Jump to content

Sanofi

Members
  • Posts

    2
  • Joined

  • Last visited

    Never

Everything posted by Sanofi

    • Full Time
    • 0
    • 0
    Reference No. R2666300 Position Title: Head MLOps (Machine Learning Engineering Department: Artificial Intelligence Platform and Applications About Sanofi:  We are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve people’s lives. Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions. Who You Are: You are an experienced software engineer who is interested in designing and developing comprehensive solutions to support and facilitate business operations. You have a strong understanding of back-end and front-end technologies and have experience implementing highly functional solutions that can scale. You have a passion for good user experience and know how to ensure user needs are met through agile development and stakeholder engagement. You are an excellent communicator, and can work with subject matter experts, graphic designers, support teams and managers to deliver professional grade solutions. Our vision for digital, data analytics and AI Sanofi has recently embarked into a vast and ambitious digital transformation program. A cornerstone of this roadmap is the acceleration of its data transformation and of the adoption of artificial intelligence (AI) and machine learning (ML) solutions. This has enabled us, to accelerate R&D, improve manufacturing and commercial performance, and bring novel drugs and vaccines to patients faster, all in order to improve health and save lives. The Digital Team at Sanofi is a unique data-driven team. We pride ourselves on being data obsessed and highly focused on using state of the art processes along with global technologies to drive impact to our solutions. We measure our insights and products based on how they preform across the globe and hold ourselves to the highest regard as our solutions can impact millions of lives. When tackling a problem, we do not just ask how we will create a solution, but how we will create a solution that reaches across the world with the best possible societal outcome. If you are passionate about improving the health and wellness of people across the globe using Data as your means, then you should look no farther than the Digital Team here at Sanofi. Join us on our journey in enabling Sanofi’s Digital Transformation through becoming an AI first organization. This means: AI Factory - Versatile Teams Operating in Cross Functional Pods: Utilizing digital and data resources to develop AI products, bringing data management, AI and product development skills to products, programs and projects to create an agile, fulfilling and meaningful work environment. Leading Edge Tech Stack: Experience build products that will be deployed globally on a leading-edge tech stack. World Class Mentorship and Training: Working with renowned, published leaders and academics in machine learning to further develop your skillsets. Location: The Sanofi Digital Data Team uses a hybrid working model combining remote and office-based work. The Canada Digital Data Hub offices will be located in the greater downtown area of Toronto. Key Responsibilities: Work closely with the respective managers across the data organization to provide the right level of resources and skillsets to deliver AI products. Hire and Build a high performing MLOps team . Lead Sanofi’s ML development standards and best practices. Collaborate with others in engineering and product leadership to create and own the long-term roadmap and deliverables for your team. Effectively communicate the roadmap and strategy within the team and across the organization. Create and manage processes that enable team members to do their best work. Develop assets, accelerators, and thought capital for your practice by providing best in class framework and reusable components. Work in agile pods to design and build cloud hosted, ML products with automated pipelines that run, monitor, and retrain ML Models. Oversee the design of AI/ML apps and the implementation of automated model and pipeline adaption. Validation working closely with solution architects, data scientists and data engineers leads/managers. Bring your deep expertise in cloud architecture / DevOps to analyze and recommend enterprise-grade solutions for operationalizing AI / ML analytics. Lead development end-to-end (Data/Dev/ML)Ops pipelines based on in-depth understanding of cloud platforms, AI lifecycle, and business problems to ensure analytics solutions are delivered efficiently, predictably, and sustainably. Researching and gain expertise on emerging tools and technologies. An enthusiasm to ask questions and try and learn new things is essential. Prototype and demonstrate solutions. Be innovative. Use your judgment to craft solutions to complex problems or seek guidance as needed. Support life cycle management of deployed ML apps (e.g., new releases, change management, monitoring and troubleshooting). Work as MLOps subject matter expert (e.g., develop and maintain enterprise standards, user guides, release notes, FAQs). Build processes supporting seamless MLOps (e.g., app monitoring, troubleshooting, life cycle management and customer support). Walk stakeholders and solution partners through solutions and reviewing product change and development needs. Maintain effective relationships with stakeholders to develop education and communication content as per life cycle events. Drive impact by leading your teams to deliver results with sustainable engineering practices. Co-Own project planning and execution of multiple features and releases. Contribute to architecture, design, and code reviews. Also not be afraid to do some hands-on development/debugging to solve complex use cases. Lead a team of high-performing engineers and tech leads. Help them grow their skillset through hands-on experience, mentorship, and feedback. Nurture a culture of excellence on the team through hiring diverse and talented engineers, predictable execution, and a high level of quality. Participate to the engineering community and be a trusted advisor to your colleagues and to our stakeholders. Key Requirements: 10+ years of relevant experience. Demonstrated Design-to-implementation consulting experience across digital and the establishment of engineering functions. Demonstrated use of technologies to develop, monitor and deploy products (e.g. Github, GitAction, Splunk, cloudwatch, Argo, Spark, MLflow, …). Demonstrated ability in the establishing of MLOps practice and associated practices in complex environments. Experience in coaching and leading agile dev teams, and building a team and culture around agile development practices. Demonstrated experience in building AI scalable industrialized products, establishing the vision for major products. Experience interacting and influencing cross-functional stakeholders to execute high-impact projects. Demonstrated leadership and coaching skills to develop individuals and teams. Experience in data science, statistics, software engineering, modular design and design thinking. Experience developing CI/CD pipelines for AI/ML development, deploying models to production, and managing the lifecycle in a regulated environment. Experience building and deploying data science apps with large scale data and ML pipelines and architectures. Strong understanding of ML and AI concepts and hands-on experience in development, deployment and agile life cycle management of data science apps (MLOps). Ability to assess new technologies and compile architecture decision records (ADRs). Excellent communication skills in English, both verbal and in writing. Sanofi is an equal opportunity employer committed to diversity and inclusion. Our goal is to attract, develop and retain highly talented employees from diverse backgrounds, allowing us to benefit from a wide variety of experiences and perspectives. We welcome and encourage applications from all qualified applicants. Accommodations for persons with disabilities required during the recruitment process are available upon request. Thank you in advance for your interest. Only those candidates selected for interviews will be contacted. Sanofi, Empowering Life #DDB #GD-SP #LI-SP At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.
    • Full Time
    • 0
    • 0
    iMove, the Sanofi VIE Program, is available to citizens of the European Economic Area (EU + Norway, Liechtenstein and Iceland) aged between 18 and 28. PLEASE NOTE that since this program is primarily an international development program, candidates cannot apply to a VIE assignment in their own country of citizenship. PLEASE NOTE that applications that are only submitted in French cannot be considered by our non-French speaking partners at Sanofi worldwide. Therefore, only applications that are submitted in English will be considered. At Sanofi diversity and inclusion is foundational to how we operate and is embedded in our Core Values. We respect the diversity of our people, their backgrounds and experiences. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our employees, patients and customers. We are looking for: Associate Project Manager Manufacturing Science Analytical Technology - VIE Contract (W/M) Target start date: 01/03/2024 Responsibilities: Provide project management support to the Toronto portfolio through the planning, execution, and delivery of key priorities for assigned projects. The scope of assigned projects may include but is not limited to the following project types: Investment, Product and Process Improvement, Industrial DevelopmentProactively monitor and control project execution to ensure all project milestones are met within approved timelinesCollaborate with local and global stakeholders from Engineering, MSAT - Manufacturing Science and Analytical Technology, Supply Chain, Production, Research&Development , Quality, and Regulatory Affairs to achieve project schedule, budget, and resource targetsMonitor financial performance of assigned projects and ensure that the budget and quarterly referential targets (T0, T1, etc.) are accurately forecasted and can be realistically achievedActively manages project risks and issues and is able to assess, escalate, and communicate the impact of the project risks/issues to stakeholders from all levels of managementChallenge ways of working to optimize timelines and costs while maintaining compliance to regulatory requirements and internal policies (VIA Project & Program Management Handbook and Sanofi project management standards and best practices)Establishes and maintains effective project management standards, tools, processes, and best practices within project teams to ensure successful delivery of all project milestones Requirements: MSc. in Biotechnology, Biochemical Engineering, or equivalent in Bioprocess or Chemical Engineering & Microbiology Minimum 1-3 years direct experience within the life sciences / biotechnology / pharmaceutical industry Previous experience in project management is requiredProficient in English and French (oral and written) is a mustAbility to analyze and interpret data and communicate clear and actionable recommendationsAbility to influence and communicate with a diverse group of stakeholders from multiple levels of managementAbility to work autonomously At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.
    • Full Time
    • 0
    • 0
    Reference No. R2720940 Position Title: Lead, Forecasting Department: Business Operations & Support, Canada ​ Location: Mississauga, Ontario About Sanofi Specialty Care Sanofi's specialty care business unit focuses on rare diseases, rare blood disorders, neurology, immunology, and oncology.  Sanofi's ambition is to leverage science and innovation to improve people’s lives and be the industry leader in immunology and oncology. Its approach is shaped by a long history of developing highly specialized treatments and forging close relationships with physician and patient communities. At Sanofi, we chase the miracles of science to improve people’s lives.  We believe our cutting-edge science and manufacturing, fueled by data and digital technologies, have the potential to transform the practice of medicine, turning the impossible into possible for millions of people.  Position Summary: The primary role for the incumbent is to provide brand and franchise level forecasting insights for both corporate and incentive compensation reporting. This role will be responsible for the forecasting/incentive compensation function, with the objective to facilitate the collection, interpretation and dissemination of customer insights to strengthen insight driven decision making. The main activities under their leadership are: Provide thought leadership to forecasting and incentive compensation processes. Responsible for contributing to strategic vision and development of operational plan for relevant business analytics tools including reporting, and implementation. Responsible for supporting the organization’s performance tracking and management system using and integrating multiple data sources. Responsible for the development of field sales insight strategy, including development and dissemination of reports and analytics for the franchise/TA. Key Responsibilities: Enhance local forecasting capabilities & deliver flawlessly next round of accurate forecast. This includes: Support and lead annual strategic/long-range planning process jointly with Finance, and in-depth review of franchise/TA, as needed. Partner with commercial teams to establish accurate, real time market and operational forecasts. Liaise with global and local teams to establish high quality market and forecast models. Review and evaluate, from a business perspective, business drivers, contracts/agreements, business proposals/cases as well as provide brand leads/franchise heads with recommendations to help achieve desired company results: Monitor reporting operations, improve pertinence and efficiency of data collection and reporting. Working with cross-functional partners including finance and trade, ensure budgeting and forecasting systems and process to achieve timely and accurate reporting to management and corporate personnel. Support franchises in connections with global and local supply; Work with brands to create demand scenarios in support of the long-range planning process. Leverage disparate data sources and work with unstructured data. Deploy and explain predictive Time-series and Regression Machine Learning models as well as dashboarding capabilities to better inform financial, commercial and supply chain teams of material risks and opportunities. Drive the expansion and adoption of Innovation forecasting models. Forecast innovation sales & profit potential at all stages of the qualification funnel from early idea to pre-launch based on previous statistical literature. Track post-launch forecast accuracy and core KPIs to diagnose deviance root-causes and propose actions course correct. Industrialize innovation forecast capabilities leveraging new tech platforms & technologies with internal or external vendors. Evangelize organization on innovation forecast best practices. Conduct regular consolidation of innovation forecast successes & failures for continuous improvement. Create QA processes to reassess the validity of our model assumptions over time. Support other Advanced Analytics needs such as: Promote best practices and evangelize insights from marketing measurement tools and optimization to increase ROI year-on-year. Contribute to support ad-hoc request for data analytics, consumer, and market understanding. Navigate organizational complexity effectively in a professional manner. Key Requirements: BA/BS in Business or Finance or relevant area. Advanced degree (MBA, MSc, etc) highly preferred. Minimum of 5 years of experience in forecasting is desirable, preferably in a health care setting; relevant experience in consulting focused on health care analytics and/or data science would also be considered. Evidence of team and project leadership and project management is required; Proven history of working and delivering on multiple projects simultaneously, with tight deadlines and changing priorities is required. Deep expertise of forecasting techniques (ARIMA, Smoothing, Fast-Fourier Transform) & libraries (Prophet, Tensorflow, Modeltime, ...) is a plus as well as notion of marketing mix, & other type of measurement techniques (A/B testing, trigger & survival models, transfer-demand models). Strong experience with forecast-related data sources such as external trends (google trends, weather, flu, pollen, macro-socio/economic indicators, …) and category to SKU historical sales. Detail-oriented and comfortable with all aspects of the analytics process, including managing many datasets, analyzing, and ensuring data quality, directing the work of analytics partners internal or external, and generating and validating key insights, relentless at influencing business decisions. Prior work experience with management consulting or investment banking would be an asset. Excellent people and communication skills. Excellent analytical abilities and problem-solving skills. Ability to think strategically and act in a detailed, hands-on manner. Experience in cross-functional teams without direct line authority. Ability to build consensus across functions. Advanced Computer skills including expert proficiency in MS excel; experience in statistical software or social media mining software is an asset. Fluency in written and spoken English; French is an asset. Self-starter who functions well independently and within a team. Languages: English - fluent. French - proficient. Pursue Progress. Discover Extraordinary Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people. Watch our ALL IN video and check out our Diversity, Equity and Inclusion actions at sanofi.com! Sanofi is an equal opportunity employer committed to diversity and inclusion. Our goal is to attract, develop and retain highly talented employees from diverse backgrounds, allowing us to benefit from a wide variety of experiences and perspectives. We welcome and encourage applications from all qualified applicants. Accommodations for persons with disabilities required during the recruitment process are available upon request. Thank you in advance for your interest. Only those candidates selected for interviews will be contacted. Follow Sanofi on Twitter: @SanofiCanada and on LinkedIn: https://www.linkedin.com/company/sanofi #GD-SG #LI-GZ At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.
    • Full Time
    • 0
    • 0
    Reference No. R2720291 Position Title: Medical Scientific Liaison - Autoimmune type 1 Diabetes Department: General Medicines Medical Canada Location: Toronto, Ontario, Remote CA About Sanofi – www.sanofi.ca At Sanofi, we chase the miracles of science to improve people’s lives. We believe our cutting-edge science and manufacturing, fueled by data and digital technologies, have the potential to transform the practice of medicine, turning the impossible into possible for millions of people. We never settle and now we are creating a new paradigm with a first-in-class therapy in Autoimmune Diabetes (Type 1 Diabetes). Our newest core asset, resulting from the acquisition of Provention Bio in General Medicines Autoimmune Type 1 Diabetes space, aims at delaying the onset of stage 3 type 1 diabetes. This means that for the first time, people at risk of developing this lifelong disease have fresh hope. What delayed onset means is more time for children to be children with less healthcare and more care-free childhood. The delay also gives families and healthcare professionals more time to prepare care plans for a later diagnosis. We now present an exciting opportunity for you to go further faster. If you’re excited by the prospect of bringing this innovative, first-in-class therapy to more people at risk then we want to hear from you as we build a great team who will work at the intersection of our growth in immune-mediated diseases and disease-modifying therapies in areas of high unmet need. This is a chance to bring your energy, expertise and experience to truly transformative and career-defining leadership roles where you can help change countless lives. In return, you will have a rare opportunity in pharma – the chance to help disrupt and delay a debilitating and widespread disease. This really is a ‘prime time’ role offering you huge visibility and the chance to fast-track your career in healthcare. Innovation, patient focus and disruptive thinking are all key threads of our Play To Win culture. Our Autoimmune Type 1 Diabetes journey starts now and you can help us chart a new course – not only for Sanofi but for preventive healthcare. Now is the time to add your strengths to ours! Position Summary: We are seeking a highly motivated and visionary leader interested in shaping the management of people at risk of developing/or with T1 diabetes. As an Executive MSL, you will be the trusted scientific partner in the field for external experts and decision-makers (incl. KOLs, Endos, other scientific stakeholders) engaging in mutual scientific exchanges to accelerate data dissemination on a first-in-class therapy in Autoimmune Type 1 Diabetes. You will be primarily responsible to enhance the understanding of the scientific and medical value of our innovative product in the therapeutic area. Reporting to Autoimmune type1 Diabetes medical lead, this role is strategically positioned to realize the ambition for T1D and contribute to the overall future success of Sanofi. Key Responsibilities: Being the trusted scientific partner to key external experts (incl. KOLs, Endos, other scientific stakeholders), establishing and maintaining robust, long-term peer relationships. Conducting high-touch scientific exchange with experts from key accounts (e.g., KOLs in Centers of Excellence) and beyond (e.g., broader HCP groups/scientific stakeholders outside of Centers of Excellence) to convey a compelling and highly scientific narrative on T1D disease stages, importance of screening and treatment, leveraging innovative story telling techniques. Engaging with experts from key accounts (e.g., KOLs and Endos and pediatricians in Centers of Excellence) to share scientific data, answer scientific questions and support them in developing best practices (i.e., on infusion protocols). Linking internal partners to external thought leaders for education and research collaboration. Disseminating scientific information including innovative medical education materials and research concepts to KOLs and fostering medical and scientific information exchange between the medical community. Tailoring engagement to the different segments of stakeholders, based on comprehensive stakeholders’ mapping (incl. KOLs, Endos, other scientific stakeholders) and local go-to-market model. Working with cross-functional team to leverage an omnichannel approach in the engagement with external experts and orchestrate a high-touch & personalized engagement across different innovative channels (e.g., social media, peer-to-peer communities, websites, online portals, etc.). Operating in cross-functional teams in agile setting with self-organized teams around main customer accounts in order to improve people at risk/patient pathway and remove barriers. Keeping up-to-date about medical and scientific developments in the Type I Diabetes field. Promoting experience sharing among key external experts (incl. KOLs, Endos, other scientific stakeholders) to reinforce consensus on screening and treatment protocols at local level. Gathering data and identifying insights from in-field field stakeholder interactions and providing feedback to the cross-functional organization to feed the Medical Glocal strategy (e.g., allowing enhancement of scientific messages, plans, etc.). Supporting Market Access teams in driving the access strategy by engaging with regional payers / drug formulary committees and key account decision-makers to drive evidence / clinical value discussions (incl. treatment, health economics) – where relevant. Sharing educational materials with KOLs and broader medical audiences/groups. Answering to product-specific questions to enhance the understanding of the scientific and medical value of the treatment and shape the scientific paradigm in T1D. Coordinating and directing to right teams any direct requests for ISS, RCT, Managed Access Programs or others. Key Requirements: Advanced degree in a scientific or medical field (MD, PhD, Pharm D, Pharmacist, MsC) in relevant area. Experience in Specialty / Rare disease / Type 1 Diabetes field based medical activities. Experience in academia / research environment highly preferred. Relevant experience in a hospital or clinical setting in T1D or immunology highly preferred. Excellent interpersonal skills with the ability to utilize effective, professional communications to cultivate strong working relationships with internal and external colleagues, flexible in own approach to people and situations. Skillfully plans, prioritizes, and executes multiple responsibilities and projects. Ability to work agile, demonstrate creativity and be a strong team player. Agile learner who is comfortable operating in complex environments and working on multi-disciplinary teams. Ability to build proper environment to enable Playing to Win culture to flourish. Clear understanding of medical practice, clinical decision-making and healthcare systems related to patient care in Type I Diabetes. Advanced understanding of clinical/medical science in T1D or immunology. Ability to leverage an omnichannel approach in the engagement with external experts to orchestrate a high-touch & personalized engagement based on their level of maturity and preferences. Ability to interpret key scientific data and translate this information to meet educational and research needs. Ability to develop and convey a simple yet compelling value narrative to a broad set of stakeholders. Ability to stay abreast of data, treatment trends, and new information in the profession and ability to articulate Type 1 Diabetes knowledge and translate expert feedback into appropriate insights. Developing and providing Training and Education programs. Understanding Health Economics and value outcomes to support Market Access discussions. Knowledge of relevant healthcare systems, evolving medical landscape, regulatory and payer environment, public health, and industry trends. Digital & Analytical skills: able to analyze data, feedback and turn it into insights. Ability to operate independently (with minimal supervision) and navigate complex regulatory environments in person and via digital channels from remote (non-office based) environment. Strong communication and presentation skills in English both written and verbal. Pursue Progress. Discover Extraordinary Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people. Watch our ALL IN video and check out our Diversity, Equity and Inclusion actions at sanofi.com! Sanofi is an equal opportunity employer committed to diversity and inclusion. Our goal is to attract, develop and retain highly talented employees from diverse backgrounds, allowing us to benefit from a wide variety of experiences and perspectives. We welcome and encourage applications from all qualified applicants. Accommodations for persons with disabilities required during the recruitment process are available upon request. Thank you in advance for your interest. Only those candidates selected for interviews will be contacted. Follow Sanofi on Twitter: @SanofiCanada and on LinkedIn: https://www.linkedin.com/company/sanofi #GD-SA #LI-SA At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.
    • Full Time
    • 0
    • 0
    Reference No. R2721223 Position Title: Commercial Sales Lead Department: Autoimmune Type 1 Diabetes ​ Location: Mississauga, Ontario, Remote CA   About Sanofi – www.sanofi.ca At Sanofi, we chase the miracles of science to improve people’s lives. We believe our cutting-edge science and manufacturing, fueled by data and digital technologies, have the potential to transform the practice of medicine, turning the impossible into possible for millions of people. We never settle and now we are creating a new paradigm with a first-in-class therapy in Autoimmune Diabetes (Type 1 Diabetes). Our newest core asset, resulting from the acquisition of Provention Bio in General Medicines Autoimmune Type 1 Diabetes space, aims at delaying the onset of stage 3 type 1 diabetes. This means that for the first time, people at risk of developing this lifelong disease have fresh hope. What delayed onset means is more time for children to be children with less healthcare and more care-free childhood. The delay also gives families and healthcare professionals more time to prepare care plans for a later diagnosis. We now present an exciting opportunity for you to go further faster. If you’re excited by the prospect of bringing this innovative, first-in-class therapy to more people at risk then we want to hear from you as we build a great team who will work at the intersection of our growth in immune-mediated diseases and disease-modifying therapies in areas of high unmet need. This is a chance to bring your energy, expertise and experience to truly transformative and career-defining leadership roles where you can help change countless lives. In return, you will have a rare opportunity in pharma – the chance to help disrupt and delay a debilitating and widespread disease. This really is a ‘prime time’ role offering you huge visibility and the chance to fast-track your career in healthcare. Innovation, patient focus and disruptive thinking are all key threads of our Play To Win culture. Our Autoimmune Type 1 Diabetes journey starts now and you can help us chart a new course – not only for Sanofi but for preventive healthcare. Now is the time to add your strengths to ours! Position Summary: We are seeking a highly motivated and visionary leader interested in shaping the management of people at risk of developing/or with T1 diabetes. As the Commercial Sales Lead in Canada, you will be primarily responsible to hire, develop and coach our team of Key Accounts Managers in Autoimmune Type 1 Diabetes (aT1D). You will work with other cross functional team members, to identify and build our customer segmentation, to facilitate person-at-risk / patient identification and ensure infrastructure is in place so patients can be treated in a timely and efficient manner with a first-in-class therapy in aT1D. Reporting to Head of aT1D Canada, this role is strategically positioned to realize the ambition for T1D and contribute to the overall future success of Sanofi. Our Autoimmune Type 1 Diabetes journey starts now, and you can help us chart a new course – not only for Sanofi but for preventive healthcare. Key Responsibilities: Responsible for salesforce planning and execution of strategies, tactics, and actions. Support the Head of aT1D to perform the necessary market assessment to confirm salesforce resourcing and deployment. Recruit and build the salesforce team in a timely manner and perform all necessary team training pre-launch to effectively commercialize. Ensure achievement of sales and A&P spending. Ensure excellence in execution at the local level by setting objectives, milestones, and tracking KPI’s and metrics to measure commercial performance. Support team to manage key accounts and develop strong relationships with key customers including KOLs, treating physicians, nurses, and aT1D counsellors Lead or supervise negotiations with retail and hospital pharmacies, hospital administrators, infusion clinics and aT1D treatment centres to ensure patient access to timely infusion services Partnering with the Launch Lead, aT1D and other cross-functional team members to build the Glocal brand strategy (Integrated Growth Plan), providing insights on local ecosystem, trends and care pathways (e.g., treatment landscape, T1D awareness level, main prescribers and referrers along the patient pathway, etc.) to inform the strategic development process and adapting it to the local context. Plan and execute project leading to achievement of sales targets and strong KOL involvement. Ensure an optimal and continuous training plan is developed for salesforce. Monitor implementation of brand campaigns in the field through co-visiting/HCP feedback, drive local cross functional teams to secure brand strategies and customer engagement planning. In collaboration with various support functions, ensure sufficient product supply, favourable market access and efficient distribution assigned brands within Canada. Developing understanding of target accounts (e.g., Centers of Excellence or other key accounts in the Autoimmune diabetes local care pathway) functioning and existing screening/infusion infrastructure to identify operational barriers that could prevent patients from accessing screening or treatment administration. Developing strategic account plans including prioritization, based on identified barriers to address and opportunities. Engaging with accounts’ key stakeholders to convey a compelling narrative on T1D and screening and create general disease awareness (incl. T1D prevalence, severity and stages / disease progression pre-launch and treatment options post-launch) and tailoring engagement to the stakeholders’ level of maturity. Leveraging omnichannel approach with salesforce (e.g., F2F, social media, peer-peer webinars, etc.) to ensure a high-touch and personalized engagement with key accounts’ stakeholders. Key Requirements: Advanced Bachelor's degree in business, life sciences, or a related field. MBA is a plus. Desired experience in Specialty / Rare disease / Type 1 Diabetes. Minimum 7-10 years of experience within the pharmaceutical / biotech industry. 2 years of sales management in the pharmaceutical/biotech industry experience preferred. 2 years of direct sales experience in pharmaceutical industry preferred. Proven experience in leading a high performing team to deliver on results. Growth-focused and executional mindset. Ability to coach and develop a team to work agile and demonstrate creativity. Excellent interpersonal and communication skills, with ability to effectively engage internal and external stakeholders, build and cultivate strong working relationships. Unconventional thinking, always looking for new ways to achieve business goals. Self-driven, results-oriented with ambition for optimal results. Resilience, rigor and reliability. Ability to build proper environment within the team to enable Playing to Win culture to flourish (e.g., stretch & Patient focus). In-depth understanding of the market, competition and future market trends. Supply chain & distribution management. Strong analytical capabilities, incl. forecasting. Ability to develop, with cross-functional teams, a local multi-factorial stakeholder engagement strategy for a broad stakeholder ecosystem by understanding how they impact each other. Deep understanding of the entire local healthcare ecosystem. Driver and curious to learn new initiatives in digital pharma landscape. Languages: Strong communication and presentation skills in English (French is a plus) both written and verbal. Travel: More than 50% time Pursue Progress. Discover Extraordinary Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people. Watch our ALL IN video and check out our Diversity, Equity and Inclusion actions at sanofi.com! Sanofi is an equal opportunity employer committed to diversity and inclusion. Our goal is to attract, develop and retain highly talented employees from diverse backgrounds, allowing us to benefit from a wide variety of experiences and perspectives. We welcome and encourage applications from all qualified applicants. Accommodations for persons with disabilities required during the recruitment process are available upon request. Thank you in advance for your interest. Only those candidates selected for interviews will be contacted. Follow Sanofi on Twitter: @SanofiCanada and on LinkedIn: https://www.linkedin.com/company/sanofi #GD-SA #LI-SA At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.
    • Full Time
    • 0
    • 0
    We are Sanofi. We are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve people’s lives. Our teams across the world strive to transform the practice of medicine, turning the impossible into the possible for patients. We provide potentially life-changing treatments and the protection of life-saving vaccines to millions of people, and affordable access to our medicines in some of the world’s poorest countries. We are looking a talent for the Head of Global Vaccines Manufacturing Excellence role. About the Team: We are Sanofi. We are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve people’s lives. Our teams across the world strive to transform the practice of medicine, turning the impossible into the possible for patients. We’re transforming strategy, culture, and process through ONE Sanofi Industrial Ambition that will connect our science to the communities we serve. Vaccines Industrial Affairs’ unique expertise in vaccine manufacturing contributes to sanofi Vaccines’ public Health mission and company growth. Our ambition is to work together as one organization to become Best in Class – the worldwide reference for vaccine manufacturing, and to maintain a sustainable and reliable supply of cost-competitive quality vaccines for our customers around the world. Main responsibilities: Reporting to the Head of Industrial Excellence and Strategy, the Head of Manufacturing Excellence is accountable for developing, planning and leading the performance roadmaps for MSV sites network in order to improve business performance to achieve Best in Class ambition, maintaining thus global competitiveness. Boost industrial performance He or she develops and lead implementation of the Sanofi Manufacturing System (SMS2.0) program for the 10 manufacturing sites in MSV regarding Sanofi Manufacturing System to continuously improve all aspects of manufacturing operation, sustaining cost reduction improvement, in compliance with Sanofi Quality and HSE standardsEstablish harmonized Production Capacity measurement system & related Asset utilization improvementsDrive Productivity improvements programs: yields & process losses, write-off,Drive Plant cycle time and release Lead time adherence/reduction programs He or she manages the Vaccines pipeline of procurement-related saving initiatives including Identify and explore areas of opportunity by structuring, facilitating, and coordinating “idea generation workshops” with Procurement to find further saving initiatives on Materials, Indirect and MRO & EnergyEnsure each site has an up-to-date portfolio of savings initiatives endorsed by the Site Head Monitor industrial performance & Compare with Benchmark to strive for best in class He or she establishes the measurement system to monitor overall the MSV and sites performance Organize +QDCIS dashboard from level5 and below to prepare for level 6 escalationMonitor performance of individual sites to identify and implement improvement measures in collaboration with site senior management and site ME managers, through monthly reviews of performance versus defined targets, ensuring accountability at site level for resultsTrack monthly performance dashboard and monthly reportFrame budget and StratPlan exercises to focus first on performances drivers before financial impacts Industrial Methods Support the LTIP process through the capacity reporting in ConvergenceOrganize the regular update of the production capacity registerPerform Global capacity analysis for LRP and budget preparations as well as the review process.Provide expertise services/intervention to address troubleshooting or debottlenecking of process flows related to equipment, including diagnostic for transformation Benchmarking Build a network internally and externally to organize benchmark studies related to the best practices in/out of our industryOrganize Team participation into the Company benchmark studies (POBOS)Make proposals to implement the best practices in the network. Build capabilities for industrial performance Establish the capabilities building system for the networkSupport manufacturing sites as required, ensuring that the correct organization, resources and expertise are in place. Develop and nurture Continuous Improvement champion networkConduct and/or support Lean workshops and SMS Lean Academy training. Actively support SMS certification program.Organize communication between sites on SMS activities to ensure best practice sharing, cross-fertilization and implementationLeverage all Sanofi M&S Industrial Performance programsConnect with IPL’s IPM’s community to challenge all investment projects and provide performance intervention alternativesPromote performance mindset at all levels of the organization through Lean events, standardization and simplification initiatives, collaborators priorities setting up and review, recognition system, and learning organization. Manage Sourcing Risk through the CMM Organization Defining and agreeing on the procurement-related risk strategy and objectivesRegularly mapping procurement-related risk areas and identifying specific risksDeveloping and implementing a Supplier Risk Framework aligned with MSV Sourcing Risk RoadmapOwning and maintaining the risk register for materials, suppliers, specifications, regulations, and financialsCreating awareness of risk amongst procurement teams and adjacent functions to ensure effective due diligencePrioritizing identified risks and implementing measures to prevent or minimize their impact, while ensuring alignment with the business About you Experience: Crisp understanding of vaccines industrial requirements and commercial universe. Economics & financial knowledge & expertise. Experience in operational roles. Demonstrated success in leading and evaluating performance improvement programs. Ability to train staff in performance improvement methodologies. Demonstrated success in establishing and maintaining cooperative partnerships at both local and international levels. Exposure to cross sites & cross GBUs networking.Soft skills: Change management skills. Disrupts the status quo while remaining pragmatic and focus on priorities. Able to lead & animate networks, teams, experts - Strong communication skills. Strong leadership skills to engage direct team as well as manage multiple/transversal teams. Persuasion / bringing other together to gain consensus and reach global optimum. Strong capabilities on stakeholder management to drive decision making process. Complex problem solving / Judgment & decision making / Critical thinking. Result oriented. Change management skills. Business acumenTechnical skills: Strong experience in Industrial Performance or Site Manufacturing with proven track record in Lean Manufacturing Principles / Lean transformationDrive cost efficiencies while maintaining all safety, compliance and “time to market” objectives. Languages: Fluent in English Sites : France (Lyon, Gentilly, Marcy l'Etoile, Val de Reuil), Swifwater, TorontoTravel: Ability to travel worldwide ~30% of the time#LI-FR Pursue progress, discover extraordinary Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people. At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity. Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com! #LI-FR At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all. As part of its diversity commitment, Sanofi is welcoming and integrating people with disabilities.
    • Full Time
    • 0
    • 0
    iMove, the Sanofi VIE Program, is available to citizens of the European Economic Area (EU + Norway, Liechtenstein and Iceland) aged between 18 and 28. PLEASE NOTE that since this program is primarily an international development program, candidates cannot apply to a VIE assignment in their own country of citizenship. PLEASE NOTE that applications that are only submitted in French cannot be considered by our non-French speaking partners at Sanofi worldwide. Therefore, only applications that are submitted in English will be considered. At Sanofi diversity and inclusion is foundational to how we operate and is embedded in our Core Values. We respect the diversity of our people, their backgrounds and experiences. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our employees, patients and customers. We are looking for: Global Regulatory Affairs Associate - VIE Contract (W/M) Target start date: 01/11/2023 Responsibilities: Coordinate regulatory activities to support the Global Submission Plan with the global product regulatory team (GRT), track and update Global Simultaneous Submission plan (GSS)Coordinate regulatory activities to support the product lifecycle or development plansParticipate in the preparation of consultations with authoritiesSupport the Global Regulatory Lead (GRL) in reference to product regulatory team (GRT) meetings composed of different regulatory experts (RegCMC, RegLabeling, Regional Regulatory contacts, Regulatory Operations) : preparation, meeting minutes, follow-up of actionsDevelop the document summarizing the Global Regulatory Product Strategy (GRPS) Requirements: PhD, Pharm D or DVM or MSc in Biology, Life Science, or related field of study, Master of Science in Regulatory Affairs1 year of previous fill-time working experience preferably in Regulatory AffairsPharmaceutical industry experience is preferredYou can demonstrate solid English oral communication, presentation and writing skillsYou have solid knowledge of MS Office software, knowledge of Think-Cell would be a plusYou are rigorous and known for your analytical and synthesis skillsYou are motivated and open-minded, you like working in a team and interacting on cross-cutting and multicultural subjectsYou have a solid knowledge and understanding of complex medical and scientific subject matter as well as evolving regulatory policyYou have an unquestionable ethics, professional integrity, and personal values consistent with Sanofi values At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.
    • Full Time
    • 0
    • 0
    Position Title: Vaccines Sales Professional – Scranton, PA Who You Are: You are a self-motivated sales professional who is equally passionate about our mission to chase the miracles of science to improve people’s lives. You understand the importance of achieving your business goals through a customer focused plan of action and being a team player by sharing your knowledge and positive energy to support team success. One of the many qualities you have is discovering your customer’s needs to align on common goals and being open to doing things differently to achieve better results. Where You Will Work: Northeast Region The Team: The Sanofi Pediatric Sales Team is responsible for the promotion and sales of vaccines for children and adolescents. We are a team of sales professionals, passionate in our commitment to prevent deaths from preventable diseases and to our customers and their patients. We share a culture of company and employee commitment where we value the talent of our team members and the achievement of our business goals. Job Highlights: The Vaccines Sales Professional (VS) is responsible for achieving/exceeding annual territory sales quotas across a diverse customer base within both public and private sectors (e.g. Physician Offices & Medical Groups, Integrated Health Networks, State Departments of Health, Vaccine for Children’s program, Federally Qualified Health Centers). The VS will engage customers through virtual and face to face interactions, achieving the optimal reach, frequency, and outcomes through appropriate planning and call implementation. The VS is required to develop and maintain expertise in disease and product knowledge, utilization of business data, business planning and organization, customer engagement and selling skills, team collaboration, technical skills, and territory administration. The VS is expected to have a thorough understanding of the national brand strategy, brand messaging and resources to effectively implement specific account action plans based upon their unique marketplace. The VS is required to develop a strategic partnership with his/her customers using the Sanofi Pasteur sales model to uncover customer business needs and identify product/non-product opportunities to address their needs. VS is responsible for embracing team selling by communicating, collaborating, and orchestrating with other appropriate field and home office team members to ensure an aligned Sanofi Pasteur approach to customers. Basic Qualifications: Bachelor of Arts (BA) or Bachelor of Science (BS) degree from an accredited four-year college or university (or the equivalent if education obtained outside of the United States) 2 years of pharmaceutical, business to business sales and/or medical experience Other pharmaceutical experience where individuals have demonstrated the ability to influence others may be considered (marketing, operations etc.) Preferred Qualifications: Candidates who reside within the territory or a commutable distance The Fine Print: Candidate possesses a valid driver’s license and a record of safe driving according to Sanofi policy Candidate is able to provide 2 years of performance review documentation Candidates must complete all fleet safety training and must maintain an acceptable driving record regarding accidents and incidents. Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. #GD-SP #LI-SP At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.
    • Full Time
    • 0
    • 0
    The Strategic Account Manager will… Assume the leadership role within assigned accounts, providing overall account leadership to cross-functional internal and external team members as needed. In this capacity, the SAM will assume responsibility for assigned strategic customers and manage each as a business partnership on behalf of Sanofi. Additionally, the SAM will bear full responsibility for building a strategic account plan for assigned accounts, as well as organizing and deploying the appropriate resources within Sanofi to drive value co-creation with customers and meet/exceed Sanofi’s revenue targets. Effectively manage and grow a network of trust-based relationships with external stakeholders to generate revenue through genuine partnerships within Sanofi’s largest and most complex customers. The SAM will develop a deep understanding of the customer’s business which includes their pressures and drivers, priorities, as well as their related challenges and opportunities. They will maintain working knowledge of the customer’s business model, strategic goals and objectives, and their position within the healthcare environment including value-based health care, their competitors, and financial levers. Identify and qualify high value opportunities within their accounts by working directly with the customer to develop and drive growth strategies, team-to-team alignment, and executive relationships together with internal cross-functional team members. Accordingly, the SAM will conduct business coaching and strategy session with their account teams to facilitate the co-creation of customer value and ensure ongoing internal alignment and account growth. The SAM will function as the central focal point for communications regarding account planning, strategy, collaboration, resource allocation and customer engagement. Basic Qualifications Minimum required skills & experience: Bachelor’s degree Broad understanding of health system business, decision making processes & market trends with a proven track record of accessing C-suite to D-suite decision makers Proven ability to translate health system market knowledge and develop strategic plans with internal stakeholders The ability to execute tactical initiatives, provide ongoing feedback, and prioritize multiple projects. Broad field sales experience with demonstrated success working with P&T committees, decision makers & influencers in Hospitals, Health Systems, IHNs and other large-organized customers Possesses strong business acumen and strategic thinking skills Self-directed and organized with excellent execution and planning skills Ability to adapt and change in a shifting environment Excellent communication skills both written and oral Must possess valid driver’s license, be eligible for insurance coverage and must be able to safely operate a vehicle Minimum preferred skills & experience: MBA or other advanced degree Strong data analytics Experience working in Market Access, Pricing, Contracting or Finance Proficient with MS Office and customer management databases Experience leading teams with demonstrated impact & influence with key internal stakeholders Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. #GD-SP #LI-SP At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.
    • Full Time
    • 0
    • 0
    Job Summary The CDM Team Manager is responsible for the oversight of a team of Clinical Data Managers and all their clinical trial activities and deliverables as well as their transversal activities. The CDM Team Manager role requires a thorough understanding of clinical data, efficiencies in guiding its collection, development/maintain data acquisition standards to ensure quality and regulatory compliance, oversight of its management and assurance of its integrity in the clinical trial process. The CDM Team Manager is responsible for managing, coaching, and developing employees to develop operational excellence through ongoing training of internal data management employees and/or consultants. Key Responsibilities Ensures that, within his/her CDM team, clinical trials are compliant and documented as appropriate within the company operating procedures and regulatory guidelines. Ensures that, within his/her CDM team, the integrity and quality of the data that can be provided to Health/ Regulatory authorities for submission. Ensures an efficient implementation and follow-up of CDM activities within the partnerships for outsourced trials. Also participates in the oversight of communication, planning, resources within the partnership in collaboration with the Partnership Manager. Participates in the overview of Standards activity to support the definitions and updates of Standards interacting with Standard Manager. Follows the Key Metrics within the CDM platform for internal/outsourced trials and ensuring/supporting Major Milestones achievements in a timely manner. Works in collaboration with Clinical Department, to contribute to budget, priorities and to allocate resources to projects in development and to support needs at clinical team level. Participates in the strategy/orientation definition of Data Management activities and related environments within the company. Works in close collaboration with Global Head CDM for budget review, resource allocation and CDM overall strategy support. Responsible for identifying, participating, and overseeing transversal initiatives concerning continuous improvement. Responsible for representing CDM both internally and externally, and for analyzing current operating techniques to insure optimal usage. Requirements & Qualifications Master’s Degree in Health/Life Sciences, Computer Sciences, or other related area. Minimum 10 years of relevant industry experience – in CRO or Pharma. Minimum of 10 years of experience in data management in clinical/medical field. Minimum of 5 years of experience in people management. Extensive knowledge of data management software and computing skills (e.g. Rave, EDC systems, eCOA, SAS, Data visualization) Extensive experience with process development within data management Skills Fluent in English Ability to work in a multi-cultural environment Effective management skills Team spirit, active listening, ability to lead working groups Ability to network and communicate with various functions Experience with audit and inspections Excellent communication and organization skills Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. #GD-SP #LI-SP At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.
    • Full Time
    • 0
    • 0
    JOB PURPOSE In the scope of clinical development of our products, the incumbent's mission is to adapt and coordinate the data management strategy during development and conduct of clinical studies/projects including mRNA projects/studies. He/she ensures integrity of data and appropriate level of quality for each clinical study in order to deliver a cleaned and accurate clinical database, allowing its statistical analysis and submission. He/she acts as Clinical Data Management (CDM) referent within the clinical team and with other departments or external partners. He/she contributes to the optimization of Data Management process as well as maintenance and evolution of Data Management in Digital environment. KEY ACCOUNTABILITIES Plan and Coordinate the development and conduct of clinical trial activities in the scope of outsourcing, with internal contacts and external partners Ensure the oversight of external vendors/partners Represent CDM with Clinical Team and other departments (Digital, PV, Labs) or external parties Manage all steps of clinical study, in line with Standards and Regulations Perform and/or ensure oversight of the processes allowing to reach the required level of quality of database until its lock in the best conditions of reliability, respect of timelines, documentation and readiness for audit and inspection Contribute to improvement of global data management process through working groups, cross-functional initiatives or involvement in technical projects by providing business expertise and project management skills Cooperate transversally within Sanofi with various partners PROFILE Requirements & Qualifications Bachelor's Degree in Health/Life Science, Technical Sciences or other related area Skills and Experience in data management in clinical/medical field and lab data (minimum 3 years) Knowledge of data management software and computing skills (e.g., Rave, EDC systems, eCOA, SAS, Data visualization, RBM Tool) Project management skills (e.g., MS Project) Knowledge in outsourcing oversight Skills Fluent in English. French notion would be appreciated Ability to work in a multi-cultural environment Team spirit, active listening, ability to contribute or lead working groups Ability to network and communicate with various functions Analytical, process-oriented with interest to drive continuous improvements Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. #GD-SP #LI-SP At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.
    • Full Time
    • 0
    • 0
    WHO WE ARE: Sanofi Pasteur is the vaccines division of Sanofi. We believe in a world in which no one suffers or dies from a vaccine-preventable disease. The Swiftwater site is in northeast Pennsylvania and is home to the production of over 120 million doses of vaccine each year. As a healthcare company and a vaccine manufacturer, Sanofi has an important responsibility to protect individual and public health. THE ROLE: The mission of this position is to develop and manage the site Operational Activities, Business Continuity Program, Site cGMP Training, and to support the Vice President, Manufacturing & Supply, Vaccines US (VP M&S, US) in managing the Swiftwater site. This role includes components of site operations (understanding and translation of the vision and priorities), facilitation (enabling leadership team to work together and getting to decision faster), project management (leading highly important projects), and bridges building (connecting the dots within the leadership team and with the rest of the organization): • By coordinating site services areas with the key stakeholders of the site including US Sanofi Research & Development (R&D), Commercial Operations (Com Ops), M&S Operations (M&S) and Sanofi Business Services (SBS) to assure that the site operations are appropriately managed, and all required activities are supported timely. • By supporting the VP M&S for management of special projects, business problem resolutions and reviewing key initiatives programs and plans as needed. • By overseeing the development and implementation of the Business Continuity and Disaster Recovery Plans for the Swiftwater Site. • By supporting site engagement & communications as needed. • By providing Leadership and Manage the Site GMP Training JOB HIGHIGHTS: 1) Provide support to the VP M&S for special projects management for site operations and/or infrastructure developments or continuous improvement programs, development of KPIs, business problem resolution, any integration activities, reviewing key initiative plans and programs. Financial analysis of certain initiatives including new business opportunities for site as needed. Assist with site strategic workforce planning. Support site vision ensuring the implementation of the change efforts to achieve the vision and strategy. 2) Responsible for M&S Training & Education by providing strategic direction and leadership for the regulated Good Practices (a.k.a. GXP) and Health, Safety and Environment (HSE) training programs within Vaccines M&S, Commercial Operations and R&D (site level), as well as providing oversight for the Security Training Program at the Swiftwater (SWR) site. In specific, the incumbent is responsible for strategy, design, development, implementation, and maintenance of the GXP and HSE training programs in order to enable site personnel and temporary staff to perform their jobs effectively. The role also provides leadership to the M&S Training and Education (T&E) staff. Support both M&S-GXP and site-wide HSE training programs at the site. Designs and periodically revisits the Site Strategy for Training & Education, according to the site strategical and tactical needs and considering the directions provided by Global /Corporate bodies like Sanofi Quality Academy (SQA) and others.This includes but is not limited to the implementation, maintenance and/or improvement of the necessary systems. Responsible for providing strategic direction and leadership for M&S, T&E staff. Provide coaching and resources needed to ensure successful Instructional Design (ID) and delivery of training programs.Influence M&S senior management decision-making and/or resource allocation through the presentation of data-driven reports on training activities and efforts; drive the analysis of current and potential training programs to determine their effectiveness and efficiency (e.g.: impact on business objectives/needs, employee satisfaction, benefit/cost ratio, etc.). 3) Take lead on site visits and develop materials/presentations for external visitors/global management visitors and management forums. • Assist the SLT members and others in developing site presentations including: • Defining and developing the scope and objective of the presentation and assuring that it aligns with the Programs and Plans contained in the site Strategic Execution Plan. • Interacting with stakeholders to obtain the data sources/information for the presentation. • Creating and refining the information to meet the objectives of the meetings. Validating the final presentation with VP M&S. • Assist VP M&S in managing materials and presentations for business committees such as Global Vaccines M&S Management Committee, Sanofi Vaccines US Business Committee, Sanofi US M&S LT and other meetings. • Coordinate visits of the site of External Visitors (government agencies) and Senior management including planning, topics, people involved, agenda, tours, etc. 4) Strives for continuous improvement and take initiatives to recommend/develop innovative approaches to training strategies, tactics, and projects. As needed, interact with Global, HSE and other training affiliates. Coordination role for the site services areas and the key site stakeholders • Coordinate with SBS, Security, HSE, Site Technical Services and Engineering teams, Site HR lead and Internal Communications to assure that the site is being properly managed to support the activities of all the stakeholders. • Member of the Swiftwater Site Management Committee (SSMC). Key responsibilities include Creating and maintaining the meeting master schedule to ensure the functional responsibilities of the SSMC are met, which includes identifying and prioritizing meeting topics/discussions, and driving the SSMC action item register among members. • This role requires regular interaction with all members of the SSMC. 5) Oversee development and implementation of the Business Continuity and Disaster Recovery Plans for the site to support uninterrupted product supply. 6) Working closely with the VP to identify and prepare for critical thought leadership engagements. Work with VP and coach the SLT members to improve the business and transversal relationships. BASIC QUALIFICATIONS: BS/BA, Engineering, or similar technical field required.15+ years of Business Management in Operations and allied disciplines such as Manufacturing, R&D or Commercial Operations.Must have excellent written and verbal communication skills, as well as the ability to actively and cooperatively work with cross functional teams.10% Travel PREFERRED QUALIFICATIONS: Masters level degree in technical field (i.e. Biology and chemical/mechanical engineering) or MBA with solid business training, is desirable.Certifications: Operational excellence/Lean Six Sigma certification – green or black belt or other certifications.Demonstrated experience in developing, aligning, socializing, monitoring, adapting, and delivering strategies in dynamic, rapidly changing environments. Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. #GD-SP #LI-SP At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.
    • Full Time
    • 0
    • 0
    Our Team: The team is involved in developing regulatory product strategies for the therapeutic area, leading regulatory efforts in the development stage and post marketing of drug products. Main responsibilities: As a key member of the GRT, and strategic partner to the GRL, the RS leverages their regulatory expertise to contribute to the definition of the global regulatory strategy, to enable and drive the execution of aligned US, EU and/or global regulatory strategy for assigned projects, including Health Authority interactions. The Regulatory strategist provides regulatory expertise and guidance on procedural and documentation requirements to GRT and cross-functional teams working flexibly within and across regions to ensure the delivery of business objectives. This position is for the Pertussis Polio Hib pediatric and booster combination vaccines. The candidate is required to have agility to work transversally on combination vaccines across Canadian and French products and if required across other Therapeutic Areas within the Vaccine Global Business Unit as needed. The scope of the licensing work can include Research and Development or established product licensing. Enables the GRL by providing quality regulatory input and position to internal business partners, including but not limited to the clinical development teams, commercial and Global Regulatory Team for assigned projects. Liaises with clinical, commercial, and other internal business partners in partnership with the GRL to enable successful regulatory outcomes. Contributes to the development of a harmonized, One Sanofi regulatory voice through participation in appropriate committees, forums at the direction of the GRL. Contributes to the Global Regulatory Team (GRT) for assigned projects in alignment with the team’s one regulatory voice for providing strategic input on the TPP, business planning, governance, and committees. May be requested to lead Global Regulatory Team meetings. May represent GRT strategic position on behalf of the GRL at regulatory forums/committees at request of GRL. May serve as a regional/local regulatory lead and point of contact with Health Authorities for projects/products in their remit, as needed. Identifies regulatory risks and proposes mitigations in collaboration with the GRL, to cross-functional teams working with Sanofi standardized methodologies as appropriate. Contributes to the development of Global Regulatory Project Strategy (GRPS) and ensures alignment with the core product labeling for products in development as well as for life cycle management of products. Participates in the development and monitoring of the global regulatory environment and updating of standards and processes related to drug and biologics regulations. Ensure that respective regulatory team members have the information necessary to contribute to the development and execution of the Global Regulatory Strategy for their responsible accountabilities. May contribute to the development of global HA interaction strategy in collaboration with non-US – non-EU regions / GRA-CMC / GRA-Devices. Attends HA meetings and collaborates with the regions / GRA-CMC /GRA-Devices to communicate the outcome to senior management as needed. May lead Health Authority meetings and preparations as designated. Leads submission team or regulatory sub team to ensure NDA/BLA/ MAA/Extensions filings meet the project timelines for product launch and is responsible for the development and update of the core global dossier / collaborates with regional lead where region-specific submissions are applicable. Leads the IND/ CTA submission strategy to ensure preparation timelines meet the project timelines for clinical trial initiation. Ensure that regulatory messaging for regulatory submission documents is aligned with program level and company objectives. Contributes to content and reviews regulated documents (such as IB, PBRER, DSUR, RMP, etc). Accountable for developing the Health Authority engagement and interaction plans for their assigned products, including the authoring of the briefing document focused on the strategy and scientific content, leading the team through meeting preparations and moderating the meeting itself. Supports operational and compliance activities for assigned deliverables, develops, executes regulatory submission planning activities, including generating submission content plans, submission tracking, and document management. Accountable for complete and accurate communication/interaction (including tracking) with the relevant HAs for the projects/products in their remit. About you Knowledge, Skills & Competencies: (Minimum required) Proactively contribute with curiosity and openness to diverse perspectives Emerging understanding of clinical development of drugs and/or novel biologics products Demonstrates business acumen, leadership, influencing and negotiation skills Effective communication skills, specifically strong oral and written presentation skills preferred Ability to work in electronic document management systems, e.g., Veeva vault is a plus Demonstrated ability to handle multiple projects/deliverables simultaneously is preferred Strong sensitivity for a multicultural/multinational environment. Experience & Education: (Minimum required) BS/BA degree in a relevant scientific discipline or MSc in Biology, Life Science, or related field with at least 5 years of relevant pharmaceutical/biotechnology industry experience, including at least 3 years of relevant Regulatory Affairs experience or Advanced degree (PharmD, PhD, MD or DVM) with at least 2 years of regulatory or relevant pharmaceutical/biotechnology industry experience required Pursue progress, discover extraordinary Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people. At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity. Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com! Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. #GD-SP #LI-SP PDN At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.
    • Full Time
    • 0
    • 0
    The US Marketing Specialist will be responsible for the development and management of several key marketing programs critical to the success of the VaxServe Marketing team. The successful candidate will support the tactical execution of the VaxServe strategy and support the Retail and General Markets teams including but not limited to the following: Marketing Material Review Process (MMRP)/Review Committee (RC) management, Tactical plan support, and execution. Budget management and conference support etc. Opportunity to join a high-performing team in a highly dynamic, fast-paced, competitive, and innovative market. The US Marketing Specialist will report directly to the US Marketing Director, Retail Marketing, and will be based in Moosic, PA. The Marketing Specialist’s responsibilities: MMRP Lead (~40%) Liaise with the MMRP coordinator to prioritize all activities for the overall review process within the team. Maintain active communication with stakeholders to ensure an overall efficient and effective review process is implemented. Monitor submission quality and issues and provide guidance and training as needed to the internal team and external partners. Perform quarterly reconciliations, comparing active materials and those hosted on 3rd party platforms to ensure only active, approved materials are being used. Maintain a strong understanding of the strategy and key tactics to help support efficiencies in the process. Expert in US pharmaceutical promotional guidelines. Manage claims library and MMRP Sharepoint including Best Practices. Marketing Execution (~30%) Support the marketing teams in the execution of tactics aligned with Strategy and priorities and based on the most important business needs. Support Deputy Directors with updates to their marketing pieces by working with the agencies to pull through needed updates and submitting and representing the pieces with MMRP. Liaise with the Conference coordinator to prepare and support conference participation. Support relationships with agencies, sales, and various Sanofi teams. Support miscellaneous projects such as influenza transactional e-mails, e-mail templates, etc. Budget Management (~20%) Serve as the central point for the team for submitting invoices and maintaining budget tracker, reconciling at month end, and reviewing with leadership. Individual Development (~10%) Routinely identify and prioritize areas of the job where improvement is needed. Develop, Maintain, and Execute Individual Development Plans with measurable, realistic, and attainable objectives. Required Qualifications: Bachelor's Degree1+ years of relevant marketing experienceAgile, able to multitask and manage multiple priorities at the same timeComfortable working in a fast-paced, innovative, and performance-driven environmentHigh attention to detailStrong written and verbal communication skills Preferred Qualifications Bachelor’s in science, business, or marketing with an understanding of the pharmaceutical industryStrong written and verbal communication skillsChallenge the status quoThink strategically and solve problemsCollaborate cross-functionallyProficient in Microsoft programs Location: Position is based in Moosic, PA and two days a week (Tuesdays or Wednesdays and Thursdays) are onsite. Sanofi US is only considering candidates who are currently legally eligible to work in the U.S. Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. #GD-SP #LI-SP At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.
    • Full Time
    • 0
    • 0
    The Strategic Account Manager will… Assume the leadership role within assigned accounts, providing overall account leadership to cross-functional internal and external team members as needed. In this capacity, the SAM will assume responsibility for assigned strategic customers and manage each as a business partnership on behalf of Sanofi. Additionally, the SAM will bear full responsibility for building a strategic account plan for assigned accounts, as well as organizing and deploying the appropriate resources within Sanofi to drive value co-creation with customers and meet/exceed Sanofi’s revenue targets. Effectively manage and grow a network of trust-based relationships with external stakeholders to generate revenue through genuine partnerships within Sanofi’s largest and most complex customers. The SAM will develop a deep understanding of the customer’s business which includes their pressures and drivers, priorities, as well as their related challenges and opportunities. They will maintain working knowledge of the customer’s business model, strategic goals and objectives, and their position within the healthcare environment including value-based health care, their competitors, and financial levers. Identify and qualify high value opportunities within their accounts by working directly with the customer to develop and drive growth strategies, team-to-team alignment, and executive relationships together with internal cross-functional team members. Accordingly, the SAM will conduct business coaching and strategy session with their account teams to facilitate the co-creation of customer value and ensure ongoing internal alignment and account growth. The SAM will function as the central focal point for communications regarding account planning, strategy, collaboration, resource allocation and customer engagement. Basic Qualifications Minimum required skills & experience: Bachelor’s degree Broad understanding of health system business, decision making processes & market trends with a proven track record of accessing C-suite to D-suite decision makers Proven ability to translate health system market knowledge and develop strategic plans with internal stakeholders The ability to execute tactical initiatives, provide ongoing feedback, and prioritize multiple projects. Broad field sales experience with demonstrated success working with P&T committees, decision makers & influencers in Hospitals, Health Systems, IHNs and other large-organized customers Possesses strong business acumen and strategic thinking skills Self-directed and organized with excellent execution and planning skills Ability to adapt and change in a shifting environment Excellent communication skills both written and oral Must possess valid driver’s license, be eligible for insurance coverage and must be able to safely operate a vehicle Minimum preferred skills & experience: MBA or other advanced degree Strong data analytics Experience working in Market Access, Pricing, Contracting or Finance Proficient with MS Office and customer management databases Experience leading teams with demonstrated impact & influence with key internal stakeholders Candidates must complete all fleet safety training and must maintain an acceptable driving record regarding accidents and incidents. Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. #GD-SP #LI-SP At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.
    • Full Time
    • 0
    • 0
    1st or 2nd shift position based on the business needs The Product Quality (PQ) Batch Release Professional supports two core activities: Lot Release Protocols & Batch Record Review/Disposition. The PQ Batch Release Professional will be involved in the creation of methods to improve the efficiency of the Lot Release Protocol & Batch Record Review/Disposition processes. Other activities may include completion of ESUM, revision of documents, and designation of work by PQ BR Deputy Director. Lot Release Protocols Obtain data to populate Lot Release Protocols (LRPs) Populate LRP according to procedure and submit the completed populated LRP to Batch Release management for review. Use current master controlled lot release protocols (LRP) to populate both QO approved test and manufacturing data for submission to regulatory agencies (CBER, BRDD, and International Countries). Ensure right first time population and accuracy of data including the highest quality laboratory data so the data is searchable under electronic LRP. Maintain master controlled documents through the EDMS system and create new templates as required. Publish the LRP for electronic submission to regulatory agencies. Ensure LRP submission meets cycle time requirements for product releases, and SAP confirmation for completion of activity. Act as designee to Batch Release management for LRP reviews. Work with Regulatory Affairs as the technical expert for the preparation and review of US and International Lot Release protocols. Batch Record Review/ Disposition Schedule, prioritize and prepare batches for disposition as applicable for all manufacturing areas at Swiftwater and distribution of final product to market. Assemble the batch jackets, which are viewed during Health Authority inspections. Prepare the Certificate of Analysis, which lists all acceptance criteria and test results related to a batch of product. Performs cGMP review of media/reagent/product batch records and release of media/reagents/products. Verifies Mfg/Expiry dates in PDRs. Prepares and/or approves commodity verification sheets for vaccine formulation, required for manufacturing to bulk. Performs batch record certification, required for manufacturing to execute the batch. Follow up and work effectively with colleagues throughout the organization to ensure timely disposition of product. Compliance and Performance Ensure training is up to date to perform the designated cGMP activities and requirements for Health and Safety. Record GMP data on documents (LRP and Batch Record dossiers) right first time with >95% accuracy, completeness and compliance. Execute on time changes to master documents such as LRP aligned with revised product specifications to ensure changes are completed on time. Complete SAP transactions in real time as activities are performed. Meet cycle time commitments for population of LRPs per departmental agreements/commitments, support Right First Time projects. Perform all other tasks as assigned by Manager. Continuously reviews PQBR processes, and recommends, develops and implements efficiency and quality enhancements. QUALIFICATIONS: Bachelor’s Degree Preferred Qualification: Experience in GMP working environment The position requires intense concentration and visual examination of GMP documents. Data not entered right first time causes delay in product disposition to the market, potential loss of sales, potential recall, and/or customer complaints. Certification of working documents, review and release of media reagent and review of lot release protocols are measured for productivity and quality. The activities must be performed with high level of quality to ensure quality and meet the needs of our customers. The incumbent must work within the policies, procedures, and regulations as required by the Company and under the Occupational Health and Safety Act. Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. #GD-SP #LI-SP At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.
    • Full Time
    • 0
    • 0
    POSITION OVERVIEW RESPONSIBILITIES: Lot Release Protocols Obtain data to populate Lot Release Protocols (LRPs) Populate LRP according to procedure and submit the completed populated LRP to Batch Release management for review. Use current master controlled lot release protocols (LRP) to populate both QO approved test and manufacturing data for submission to regulatory agencies (CBER, BRDD, and International Countries). Ensure right first time population and accuracy of data including the highest quality laboratory data so the data is searchable under electronic LRP. Maintain master controlled documents through the EDMS system and create new templates as required. Publish the LRP for electronic submission to regulatory agencies. Ensure LRP submission meets cycle time requirements for product releases, and SAP confirmation for completion of activity. Act as designee to Batch Release management for LRP reviews. Work with Regulatory Affairs as the technical expert for the preparation and review of National and International Lot Release protocols. Batch Record Review/ Disposition Schedule, prioritize and prepare batches for disposition as applicable for all manufacturing areas at Swiftwater and distribution of final product to market. . Prepare the Certificate of Analysis, which lists all acceptance criteria and test results related to a batch of product. Performs cGMP review of media/reagent/product batch records and release of media/reagents/products. Prepares and/or approves commodity verification sheets for vaccine formulation, required for manufacturing to bulk. Performs batch record preparation and certification, required for manufacturing to execute the batch. Follow up and work effectively with colleagues throughout the organization to ensure timely disposition of product. Compliance and Performance Ensure training is up to date to perform the designated cGMP activities and requirements for Health and Safety. Record GMP data on documents (LRP and Batch Record dossiers) right first time with >95% accuracy, completeness and compliance. Execute on time changes to master documents such as LRP aligned with revised product specifications to ensure changes are completed on time. Complete SAP transactions in real time as activities are performed. Meet cycle time commitments for population of LRPs per departmental agreements/commitments, support Right First Time projects. Perform all other tasks as assigned by Manager. Continuously reviews PQBR processes, and recommends, develops and implements efficiency and quality enhancements. REQUIREMENTS: Specific degree, duration of experience Bachelor Degree preferred and a minimum of 1 year of related experience in a cGMP controlled/pharmaceutical industry. Key technical competencies and soft skills: Experience in SAP, Geode+, LabWare, Trackwise, Word, Phenix. Excellent report writing, analytical and communication/interpersonal skills, as well as strong organizational and teamwork abilities. Good working knowledge of the cGMPs (US, Canada, Japan, Europe) Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. #GD-SP #LI-SP At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.
    • Full Time
    • 0
    • 0
    Position Summary Positioned within the Inflammation & Immunology Therapeutic Area Research organization, you will provide strategic and operational oversight on projects from discovery through development candidate nomination in a matrixed setting and serve in early development teams as the research representative. You will play a central role in building & mentoring a project leader team and delivering high-quality clinical development candidates to build a world-class immunology portfolio. Key responsibilities Lead cross-functional project teams, represent project teams at all levels of the organization, and ensure smooth transition of the project through milestones and governance committees. Oversee the strategy, resourcing and operational aspects of the project, and be accountable for the robustness of data and quality of the overall project package for milestone transitions. Operate with a portfolio mindset and recommend Go / pause / No-Go decisions for projects based on internal data, timelines as well as competitive landscape. Propose, generate buy-in and operationalize an accelerated path for high-impact, time-sensitive projects. Provide clear viewpoints and guidance on strategic positioning and differentiation of projects. Translate project strategy and progress into meaningful presentations and communications. Serve as a key contact for TA Research Head, TA leadership and key stakeholders across Sanofi. Serve as an advisor, mentor and thought partner to functional area leads within the project, including biology leads and modality leads. Develop and maintain a strong and collaborative working relationship with key stakeholders in therapeutic area research, development, commercial, platform as well as corporate functions. Help build an efficient and collaborative project leader organization, as well as train and mentor the next generation of project leaders. Required profile PhD in immunology or an adjacent discipline in biology. 10+ years of experience in pharmaceutical R&D, preferably in Immunology. A broad understanding of targets, target classes, disease indications, unmet medical needs, modalities as well as therapeutic product landscape and trends in Immunology. Strong scientific knowledge and insight in all aspects of drug discovery processes and workflows in preclinical research, as well as experience working with development, regulatory and commercial functions. Successful track record of delivering clinical candidates by managing large cross-functional teams with complex scope across geographies. Excellent scientific, interpersonal, listening, communication, collaboration, presentation, negotiation and conflict-resolution skills. Strong project and program leadership skills and a solid track record of executional excellence, moving with fast lead-time from idea to action. Ability to build effective teams through “alignment, execution and renewal” in a complex and fast changing environment independently from reporting lines. Ability to influence and persuade key stakeholders / decision makers to obtain buy-in. Ability to think strategically to develop a compelling vision, be creative to provide novel solutions, as well as be detail-oriented to solve project-intrinsic problems and challenges. Authentic and strong communicator with an ability to discuss at all levels within Sanofi and externally, ensuring an impactful communication. Ability to facilitate and steer difficult conversations to sustainable outcomes and move to action. Preferred profile Experience with multiple drug modalities (small molecules, biologics, multi-specifics) Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. #GD-SA #LI-SA At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.
    • Full Time
    • 0
    • 0
    Reference No. R2708332 Position Title: Director of Generative AI – Text and NLP for Research Department: R&D Data & Computational Sciences Location: Toronto At Sanofi, we chase the miracles of science to improve people’s lives. We believe our cutting-edge science and manufacturing, fueled by data and digital technologies, have the potential to transform the practice of medicine, turning the impossible into possible for millions of people. As one of Canada’s leading investors in life sciences, manufacturing and research and development, we focus on delivering new and better ways to address unmet medical needs. Our life-changing and lifesaving products are grounded in science that Canadians can trust. They empower self-care, prevent and treat diseases, and help people live better. Our vision for digital, data analytics and AI Sanofi has embarked into a vast and ambitious digital transformation program. A cornerstone of this roadmap is the acceleration of its data transformation and of the adoption of artificial intelligence (AI) and machine learning (ML) solutions. This has enabled us, to accelerate R&D, improve manufacturing and commercial performance, and bring novel drugs and vaccines to patients faster, all in order to improve health and save lives. The Digital Team at Sanofi is a unique data-driven team. We pride ourselves on being data obsessed and highly focused on using state of the art processes along with global technologies to drive impact to our solutions. We measure our insights and products based on how they perform across the globe and hold ourselves to the highest regard as our solutions can impact millions of lives. When tackling a problem, we do not just ask how we will create a solution, but how we will create a solution that reaches across the world with the best possible societal outcome. If you are passionate about improving the health and wellness of people across the globe using Data as your means, then you should look no farther than the Digital Team here at Sanofi. Join us on our journey in enabling Sanofi’s Digital Transformation through becoming an AI first organization. Who You Are: You are a dynamic ML / AI expert with either industry or academic experience in leading a team focused on the development, use and adoption of generative AI for biomedical text and sequence data. We are looking for people who can use and extend large LLMs for various applications, are comfortable with relevant engineering and scaling issues needed for use of this technology in a large company but also understand the biology and the underlying methods and algorithms. In our experience the best candidate for this position are people who are passionate about the use of machine learning and AI to unlock the mysteries of science and change the way biomedical research is performed. Key Responsibilities: Lead a team of AI/ML and software engineers to evaluate, develop, extend and apply LLMs and generative AI algorithms to various use cases in Research and Development (clinical) in a large pharma company. Develop, implement, test and refine advanced ML methods for the processing, analysis, modeling integration and visualization of large scale biomedical text data. Use AI and ML methods for knowledge extraction from text and other structured data and for integrating this data with other types of structure and unstructured data using multi-modal genAI methods. Use AI and ML methods for text and report generation for clinical and regulatory applications. Be in close contact with life and medical sciences researchers to discuss project specifications, needs, data, testing and use of the products being developed. Work closely with the leading generative AI companies (our vendors) to make sure our products are state of the art and up to date. Work with developers, engineers, and MLOps to deliver AI/ML solutions to product teams. Key Requirements: PhD or MSc in computer science, machine learning, computational biology or related area with at least 6 years of experience in working on the development of methods related to deep NN, LLMs, generative AI or related topics. Deep technical understanding of the theory and practice of deep neural networks both in terms of training and inference. Experience in the use of AI for NLP and text analysis and in use cases downstream of NLP LLMs. Demonstrated ability to lead a team of data scientists and generate software solutions that are of practical use. Hands-on AI/ML modeling experience of complex datasets combined with strong understanding of theoretical foundations of AI/ML. Experience developing deployable code and deploying models in product-focused development under an agile environment. Comfortable working in cloud and high-performance computing environments (e.g. AWS, GCP, Databricks, Apache Spark). Excellent written and verbal communication, business analysis, data visualization and data storytelling skills. Strong interest in the use of AI in the life and medical sciences to improve patient lives. Pursue Progress Discover Extraordinary Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people. Watch our ALL IN video and check out our Diversity, Equity and Inclusion actions at sanofi.com! Sanofi is an equal opportunity employer committed to diversity and inclusion. Our goal is to attract, develop and retain highly talented employees from diverse backgrounds, allowing us to benefit from a wide variety of experiences and perspectives. We welcome and encourage applications from all qualified applicants. Accommodations for persons with disabilities required during the recruitment process are available upon request. Thank you in advance for your interest. Only those candidates selected for interviews will be contacted. Follow Sanofi on Twitter: @SanofiCanada and on LinkedIn: https://www.linkedin.com/company/sanofi #DBBCA #DDB At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.
    • Full Time
    • 0
    • 0
    The Clinical Study Unit (CSU) Region Head, N.A. is responsible for the organization, management and leadership of the CSU countries US and Canada. This position is business critical to reposition the US CSU first-in-class and market competitive with other biopharma operating in US. Criticality is linked to US market potential – ranked #1 commercial market at Sanofi. This senior leader role will deliver the GROW US Initiative which includes the following ambition – Increase US patient contribution to 20% of global patients in 2023, >25% beyond 2023 Re-establish US presence in Global Clinical Pivotal Studies: D&I, Pat/ Site Centricity, Operational / Quality Excellence Establish partnership with US medical, leveraging expertise and networks for KOLs, investigative sites, and diverse populations Build best-in-class integrated asset management (cross-functional strategy) when communicating in external environment, specifically with sites Deliver innovation and initiatives for ACT4PT, Global ONE, D&I, etc. as pilots in NAM Region Attract and retain key local talent, including Site Partnership Manager, Local Study Managers, and Medical Advisors with site networks for Sanofi key TAs The Clinical Study Unit (CSU) Region Head, N.A. drives and leads all clinical study activity in the North American Cluster and is responsible for ensuring clinical studies are performed according to deadlines, commitment, quality and cost efficiency. S/he ensure that the Cluster countries are aligned to the strategic company priorities and evolution of the business, developing its Cluster strategy aligned to global clinical development and medical plans. The Cluster Head assumes the role of CSU Country Head and its corresponding job description for the country s/he is based in with appropriate management support based on span of control. Main responsibilities include Internal and external stakeholder management and representation of the Cluster Defining and executing strategic roadmaps for: (1) CSU Cluster’s clinical study pipeline, (2) Future of clinical trials including the evolution of the business, (3) Business development with the key Investigators, KOLs and their institutions Providing clinical development expertise to Medical Affairs to implement global and local post-marketing studies Integrating medical and scientific intelligence to contribute to the Global Development strategy Connecting with Patient Associations, according to regulations. Attracting, developing, and retaining talent Fostering digital innovation and leading change management in collaboration with medical communities. Leading and contributing to global CSU and Clinical Sciences & Operations (CSO) workstreams Optimizing quality, cost efficiency and speed of the clinical studies in the Cluster while ensuring business continuity Serving as member of Regional CSU Leadership team as well as other relevant teams/focus group About You Significant and proven in-depth experience in Clinical Research or related area In-depth Knowledge of drug development process, clinical trial design, and broad scientific knowledge within a number of Therapeutic Areas Strategic planning experience, budget management, rigorous priority setting for self and team Knowledge of North American pharma industry and a solid network Excellent stakeholder management and influencing skills Proven ability to inspire and lead large teams through change and transformation to foster innovation and to work well in a transversal and matrixed environment Ability to manage risk and anticipate change Data based decision making Excellent project management skills Ability to present, influence and interact with C-Suite Native fluency in English (written and oral) Advanced scientific degree in science/medicine (MSc, PhD, MD, Pharma) Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. #GD-SA #LI-SA At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.
    • Full Time
    • 0
    • 0
    Group Head, Distinguished Scientist, Non-viral Gene Therapy Formulation, Genomic Medicine Unit We are seeking a Group Head, Distinguished Scientist, to join the newly created non-viral gene therapy research group in the Genomic Medicine Unit. The candidate will play a leadership role in executing and maintaining the strategy to develop targeted and non-targeted, non-viral gene therapy treatments for rare and common diseases. Specifically, the remit of the candidate will be to: Lead a dynamic, multi-site LNP formulation, chemistry and protein sciences team comprised of Ph.D. and non-Ph.D. scientists that are impactful contributors on project teams at various stages from early research, lead nomination and clinical candidate. Responsible for applying scientific expertise and judgement to initiate, design, direct and execute engineering for the formulation and chemistry of targeted/non-targeted nanoparticles to cell and/or tissues to deliver DNA and mRNA cargo, working cross-functionally with biology project teams. Continue to refine and execute chemistry and formulation strategy within the non-viral gene therapy organization that enables Sanofi to remain on the cutting edge of non-viral gene therapy. Work closely with biologists to enable design of critical go/no-go experiments to enable progression of drug candidates to the clinic Refine, and develop/implement strategy (where needed) for high throughput screening of targeting conjugates to lipid nanoparticles Contribute to lipid design while working cross-functionally with other chemists locally and globally Liaise cross-functionally with CMC process development teams to ensure smooth transition of programs from research to development when programs are at the appropriate maturity Act as an impactful contributor and leader for transversal and cross-functional initiatives. Work across R&D organization to test and advance innovative processes, hypotheses and methodologies; encourages curiosity and challenges the status quo in order to foster innovation. Enable productivity, execution with a sense of urgency, teamwork, accountability, scientific rigor and excellence. Foster a culture of employee growth and development Qualifications: Leading-edge knowledge of principles, concepts, and practices in non-viral gene delivery (specifically to LNP chemistry and nucleic acid formulation); experience of translating treatments from early research to the clinic is strongly preferred. PhD plus minimum 10 years of relevant (direct LNP formulation and chemistry) research experience in an academic or biopharmaceutical setting demonstrating continuous growth in depth and breadth of knowledge. Minimum of 5 years of experience in the biopharmaceutical setting with significant team leadership experience is required. Applies technical, functional and industry knowledge to design and execute projects that shape the strategic direction of the group. Hands-on manager and experienced leader that exercises foresight and judgement in planning, organizing and guiding complex projects. Track record of successfully applying high- level scientific judgement in a variety of complex and unprecedented situations. Flexibility to rapidly changing priorities and deadlines and ability to lead others through change in a dynamic, fast paced industry and work environment. Recognized as an outstanding scientist and subject matter expert / innovator in the field. Outstanding track record of scientific publications, presentations, patents, projects as a leading contributor or senior author. Excellent track record of project impact as a key contributor. Excellent interpersonal and communication skills: impactful oral and written communication. Experience in preparing high quality documents including technical reports, presentations, SOPs, experimental protocols and regulatory filings. Candidates must be authorized to work in the USA. Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. #GD-SA #LI-SA PDN At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.
    • Full Time
    • 0
    • 0
    Reference No. R2713383 Position Title: Computational Scientist – (Machine Learning) Digital R&D Large Molecule Research Team Department: Data Strategy Program Management Location: Cambridge, MA About Sanofi: We are an innovative global healthcare company, driven by one purpose: chasing the miracles of science to improve people’s lives. Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions. Sanofi has recently embarked on a vast and ambitious digital transformation program. A cornerstone of this roadmap is the acceleration of its data transformation and of the adoption of artificial intelligence (AI) and machine learning (ML) solutions to accelerate R&D, manufacturing and commercial performance, and bring better drugs and vaccines to patients faster, to improve health and save lives. In alignment to our digital transformation, we have launched a new major strategic initiative in 2023: the Biologics x AI Transformation. This is positioned to be a unique data-driven team, with expertise in AI platforms, data engineering, ML operations, data science, computational biology, strategy, and beyond. We are working as one to identify, design, and scale state-of-the-art AI capabilities targeted to truly transform how we research biologics.   Who You Are:  You are a dynamic Computational Scientist who will work with other scientists to apply cutting-edge computation, Machine Learning/Deep Learning approaches to revolutionize our large molecule computational tools by contributing to accelerating and improving the process of design and engineering of novel biologics drug candidates. Job Highlights:   Apply and develop artificial intelligence and machine learning (AI/ML) approaches (e.g. classification, clustering, machine learning, deep learning) on pharma research data sets (e.g. activity, function, ADME properties, physico-chemical properties, etc.) Building models from internal and external data sources, algorithms, simulations, and performance evaluation by writing code and using state-of-the art machine learning technologies. Close interactions with other Computational scientists, data engineers, software engineers, UX designers, as well as research scientists in core scientific platforms focusing on protein therapeutics, in an international context (US, Europe, China) Update and report relevant results to interdisciplinary project teams and stakeholders Key Functional Requirements & Qualifications:  Advanced degree (e.g. M.Sc., PhD) in a field related to AI/ML or Data Analytics such as: Computer Science, Mathematics, Statistics, Physics, Biophysics, Computational Biology or Engineering Sciences. Ideally 1+ years of industry experience, new grads will also be considered. Should have a track record of applying ML/Deep Learning (DL) approaches to solve molecule-related problems. Familiarity with protein structure or sequence featurization/embeddings. Familiarity with advanced statistics, ML/DL techniques including various network architectures (CNNs, GANs, RNNs, Auto-Encoders, Transformers, PLM etc.), regularization, embeddings, loss-functions, optimization strategies, or reinforcement learning techniques. Proficiency in Python and deep learning libraries such as PyTorch, TensorFlow, Keras, Scikit-learn, Numpy, Matpilotlib. Familiarity with data visualization and dimensionality reduction algorithms Ability to develop, benchmark and apply predictive algorithms to generate hypotheses Comfortable working in cloud and high-performance computational environments (e.g. AWS) Excellent written and verbal communication, strong tropism for teamwork Strong understanding of pharma R&D process is a plus. At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all. Sanofi is committed to welcoming and integrating people with disabilities. Only those candidates selected for interviews will be contacted. Sanofi is an equal opportunity employer committed to diversity and inclusion. Our goal is to attract, develop and retain highly talented employees from diverse backgrounds, allowing us to benefit from a wide variety of experiences and perspectives. We welcome and encourage applications from all qualified applicants.  Accommodations for persons with disabilities required during the recruitment process are available upon request.  Thank you in advance for your interest.  As a healthcare company and a vaccine manufacturer, Sanofi has an important responsibility to protect individual and public health.  This position will require individuals to be fully vaccinated against COVID-19 as part of your job responsibilities.     Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.  Pursue Progress Discover Extraordinary Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people. #GD-SP #LI-SP At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.
    • Full Time
    • 0
    • 0
    Our Team: Our structure biology team embedded within the vibrant scientific environment of Large Molecules Research at Sanofi in Cambridge Crossing has an exciting postdoc opportunity for a structure biologist to accelerate biologics discovery. The postdoc will work as a valued team member to apply the latest advances in structural biology and biophysics within our research portfolio while playing a role in Sanofi’s ongoing efforts to reinvent drug discovery. Click the link below for more information about Sanofi's Postdoctoral careers. Sanofi's Postdoctoral Program | Careers at Sanofi Main Responsibilities: The successful candidate is a team player with excellent communication skills, has expertise in all aspects of cryoEM from sample preparation, data collection, data processing through 3D reconstruction. The postdoc will establish a molecular cryoET and AI/ML enhanced hybrid microscopy workflow to visualize large conformational dynamics in therapeutically relevant protein complexes. About You Experience: Structure biology and/or CryoEM research contributions demonstrated through authorship in peer-reviewed publication(s) Soft skills: Self-motivated, innovative, and able to handle multiple challenging projects in parallel. Excellent presentation skills to communicate structural biology findings and enhance team-based progress. Ability to work independently, and effectively within timelines and collaborate in a highly multidisciplinary environment.Technical skills: Expertise in cryoEM grid preparation, screening, and data collection Knowledge in all aspects of single particle cryoEM data processing, three-dimensional structure determination, and model buildingBasic understanding of Linux terminal usage/shell-scripting is required. Experience in cloud computing, Python scripting and understanding of AI/ML applications in structural biology is a plus.Education: PhD in protein biochemistry, biophysics, structural biology, or related discipline. Languages: English Preferred qualifications: Protein purification, analytical and biophysical characterizationCryoET sample preparation, data collection and processing Protein engineering and in silico protein design Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. #GD-SA #LI-SA PDN At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.
    • Full Time
    • 0
    • 0
    About the Role The Associate Director, US Regulatory Affairs (RA) serves as the regulatory lead on relative Review Committees (RCs), for products in the Rare Disease, Rare Blood Disorder and Neurology portfolio. As the RC RA representative, work with brands on competitively positioning assigned products appropriately while maintaining compliance with applicable FDA regulations and company policies for the advertising and promotion of prescription drugs and biologics. Essential Functions Represents Global Regulatory Affairs (US RA AdPromo) as a member of cross-functional brand and portfolio team review committees (RC), providing regulatory input into the review and approval of US advertising, promotion, disease-state, market access, and press materials. Submits materials on form FDA 2253 when applicable. Provides US RA AdPromo strategic guidance and subject matter expertise for responsible investigational and marketed products, to meet both short- and long-term business objectives while mitigating risk. Consults with senior management and provides input to the global organization as needed. Contributes US RA AdPromo input to the development of optimal FDA product labeling on original and supplemental New Drug Applications and/or Biologics License Applications. Primary Liaison with OPDP/APLB and effectively manages relationships with FDA contacts. Establishes and maintains strong collaborative relationships with Regulatory and other R&D colleagues, as well as other stakeholders (e.g., Legal, Medical, Marketing, Communications and Compliance). Work collaboratively with medical and scientific personnel on the development and review of materials related to advertising and promotion. Participate in training of sales and marketing personnel on promotional, labeling and advertising regulations. Participates in the development, monitoring and updating of standards and processes related to drug, device, and biologics US AdPromo regulations and guidances. Other Position Responsibilities: Work with other RC team members to provide input into improvement of systems and/or processes. Provide teams with insight into changes in the regulatory environment, including updates on FDA enforcement letters, meetings, guidance documents, and policies, etc. Review current policies/practices and guidelines issued by Federal regulatory agencies and update management as needed. Competencies and Capabilities This individual is expected to competently and confidently represent Regulatory Affairs as a key member of cross-functional RC teams for assigned, as well as for all verbal and written communications with OPDP/APLB reviewers Significant understanding of the U.S. pharmaceutical marketplace, especially the rules and regulations related to the promotion of prescription drugs in the Uniteed States The individual will require strong verbal and written communication skills; strong interpersonal skills; good listening skills; strong negotiation skills; demonstrated customer focus and demonstrated ability to facilitate appropriate team decisions. Minimum Requirements: Educational Background: Bachelor’s degree from an accredited four-year college or university (Area of specialization: Life Sciences) Job-Related Experience: At least five (5) years of experience involving the direct implementation of promotional labeling and advertising regulations in the biotech/pharmaceutical/medical device industry; this must include extensive experience providing regulatory input and evaluation as part of a promotional review committee. This position can be located in Cambridge, MA or Bridgewater, NJ. Hybrid remote working arrangement can also be considered. Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. #GD-SG #LI-GZ PDN At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.
    • Full Time
    • 0
    • 0
    Sanofi is seeking a Computational Scientist to extend the application of artificial intelligence (AI) and machine learning (ML) approaches in the Drug Metabolism and Pharmacokinetics (DMPK) research platform in Cambridge, USA. As a member of the Quantitative Pharmacology Research-ML function, the individual will be responsible to: Design, develop and use AI/ML approaches to learn and predict pre-clinical and clinical pharmacokinetic (PK) and pharmacodynamic (PD) responses for small and large molecules. The scope of project responsibility will range from early discovery to support modality selection and design, to late development and First in Human PK/PD assessment. Establish AI/ML frameworks by analysing and using internal as well as public datasets. The Quantitative Pharmacology Research (QPR)-ML group of DMPK supports multiple therapeutic areas and research platforms within the broader R&D organization. Work within and across these multiple partner lines the successful candidate needs to have good communication and collaboration skills. Be expected to keep up with emerging literature, top of the art AI/ML approaches, and present both internally and externally in publications and/or external meetings. Preferred Requirements: A Ph.D. in Engineering, Computer Science, Mathematics, Statistics, Physics or a field related to AI/ML with 0-5 years of relevant research experience in an academic or industrial setting. Industry experience with a track record of applying ML/Deep Learning (DL) approaches in molecule-related problems and ADME prediction preferred. Strong familiarity with advanced statistics, ML/DL techniques Good understanding of PK and PK/PD principles and familiarity with mechanistic PK/PD modeling, and non-linear mixed effect modeling Proficiency in Python and deep learning libraries such as PyTorch, TensorFlow, Keras, Scikit-learn, Numpy, Matpilotlib. Strong familiarity with dynamical modeling tools such Matlab, Monolix, NONMEM Strong familiarity with data visualization and dimensionality reduction algorithms Experience in developing Shiny applications or other web-based tools is a plus Strong written, presentation and verbal communication skills are essential. Ability to work independently and commit to the development of self. Ability to work in a matrix and in a global environment. Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. #GD-SA #LI-SA PDN At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.
×
×
  • Create New...