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    Legal Operations OfficerLocation: Netherlands, USJob type: Permanent, Full time About the job Our Team In LEBI CHC we deliver added value as trusted partners to the CHC business, enabling its sustainable growth, caring about our consumers and people while protecting Sanofi’s independence. We are a “Feel Good Team”, of legal, Ethics, Privacy professionals that find a convivial place to perform with excellence, flourish and have fun in our journey to become the Best LEBI team In and For the World. We do so by delivering qualitative and timely legal advice, optimizing processes and resources, spotting trends and shaping the external environment, leveraging on LEBI’s CHC team capabilities and sharing accountability with the business for successes and failures. Embracing these principles is key to succeed in the position. Role modelling the Sanofi’s Play to Win values (Stretch- Take Action- Consumers/Customers centric and think One Sanofi) is another critical attribute. Main responsibilities Key contributor to LEBI CHC Strategic Planning and LEBI CHC ESG agenda, identification of KPIs, implementation and progress measurementDefine and use quantitatively and qualitatively data to identify opportunities to improve the functioning of the department, create relevant metrics and dashboardsMeasuring and reporting on the legal department's key performance indicators and metricsConduct research and benchmarking on industry trends and best practices in legal operationsManage the legal department's budget, financial reporting, and invoicing (including e-billing)Manage e-discovery and legal-hold processes in partnership with relevant digital team(s)Negotiate and monitor contracts and service level agreements with outside counsel and vendors that meet our innovation and DE&I standardsEvaluate and adopt new technologies and tools to enhance the legal department's productivity and performanceManage LEBI CHC internal and external communications, coordinating and facilitating cross-functional collaboration between the LEBI CHC department and the business and other functions in CHCBuild a knowledge management program, that nurtures a culture of sharing best practices and documentation across LEBI CHCHelp design and build targeted training programs that enhance the meets our dynamics skill building needs, in areas such as project management, data analytics, privacy, etc.Design onboarding experience for new hires of LEBI CHC, organize LEBI team meetings, events, defining and managing the agenda and follow-up on action itemsDrive the implementation of Departments initiatives and help define the right allocation of resources to business project and initiatives that need legal supportConnect and build a network of professionals and professional associations for similar roles to keep abreast of trends on efficiently and quality based LEBI Departments operations About you A minimum of 5 years of experience in legal operations, project management, or a similar role in companies or consultancy firmsA strong understanding of the legal industry, processes, and terminologyA high level of proficiency in Microsoft Office, especially Excel, PowerPoint, and Word. A good working knowledge of Visme, Google slides or similar versatile presentation toolsA working knowledge of various legal technologies and tools such as contract management systems, e-billing systems, document management systems, etc.Excellent communication, interpersonal, and presentation skillsStrong analytical, problem-solving, and decision-making skillsAbility to work independently and collaboratively in a fast-paced environmentAttention to detail, accuracy, and qualityProficiency level in EnglishAdvanced knowledge of French, will also be helpful but not a “must’A bachelor's degree in business administration, law, or a related field 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-EUR 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.
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    US General Medicines Medical - Publications Lead Job Description The US Scientific Communications team aims to support the development of high-quality medical publications to ensure clear, scientific communications of Sanofi data, enabling safe, appropriate use of and access to Sanofi medicines and to address unmet medical needs. JOB SUMMARY: The General Medicines Medical - US Cardiometabolic Publication Lead position, reporting directly to the Head, US General Medicines Scientific Communications and Medical Operations, will occupy a key leadership role by leading the strategic development, oversight, and delivery of US Cardiometabolic medical publications. JOB DUTIES AND RESPONSIBILITIES: (Note: The list below is not comprehensive; this job is also responsible for other duties as assigned) Lead the development and oversight of strategic scientific publication plans and support the execution of operational and tactical activities within the overall medical communication platforms for assigned products, technologies, or services. Lead and own strategic US Medical Publication Plans for the Cardiometabolic portfolio, ensuring robust strategic and tactical planning and implementation of congress presentations and manuscript execution in alignment with US and Global publications objectives and initiatives. Lead will oversee and/or manage publication projects, drive the recruitment/supervision of external agency partners, ensure timely delivery of tactics, collaborate with authors of peer-reviewed scientific publications to drive execution of planned publications, and understand corporate procurement processes and maintain responsibility for budgets and annual spend. Demonstrate an awareness of digital-driven publication and communication solutions that are emerging in the transmission of science and health information, incorporating solutions into strategic plans, as appropriate. Support evolving transformation of Omnichannel and support strategic development of customized HCP journeys. Also, individual will also collaborate to strategically support social media channel strategy. Collaborate closely with colleagues in US General Medicines Scientific Communications as well as cross-functionally within a matrix organization to ensure that information and knowledge transfer is conducted with internal and external stakeholders. Build effective partnerships with all stakeholders, including medical directors, statistical staff, clinical operations, field teams, HEOR, global publications, alliance partners, and CMO compliance/operations group. Demonstrate innovation, creativity, and problem-solving skills. Incorporate customer specific insights, gaps, and needs. Maintain transparency with peers and colleagues across the organization, to produce aligned strategy and tactics, while promoting synergy and avoiding duplication of effort. Sustain up-to-date working knowledge of all applicable prevailing guidance, regulation, and law that mandates the nature in which pharmaceutical organizations function. This may include but is not limited to documents prepared by FDA, OIG, DDMAC/OPDP, PhRMA, ICMJE, ACCME, etc. Ensure designated activities are appropriately executed, adherent to corporate SOPs and policies, and consistent with relevant external scientific, legal and regulatory standards. Performs other duties as assigned. REQUIRED SKILLS Ensure the successful achievement of goals, operating within all policies, procedures, and guidance to ensure compliance with SOPs and US CIA requirements, including transparency reporting. Managerial courage – ability to make difficult choices and implement successfully Strategic/critical thinking, problem solving · Innovative mindset to help evolve how publications are being created and disseminated Ability to work effectively in a rapidly evolving internal and external environment. Other responsibilities may include but are not limited to: national congress/association attendance as appropriate, planning meetings, leadership and management of publications projects and agency partners, various assigned team and cross functional working teams. Ability and willingness to maintain professional relationship with national and regional HCP authors, journals and publishers Outstanding interpersonal, written and verbal communication skills with exceptional time management skills are required for this role which requires strong cross-functional collaboration, teamwork, and stakeholder management LEADERSHIP SKILLS Plan, organize, and delegate effectively Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values and integrity to bring out the highest potential of each of our colleagues Advanced Degree: PharmD, PhD, or MD in a science subject or biomedical degree preferred. A minimum of 6 – 8 years of experience in the pharmaceutical or related healthcare industry experience A minimum of 4 - 5 years of publications experience in the pharmaceutical or related healthcare industry with expertise across all aspects of scientific publication strategy, planning, and execution during all phases of drug development and post-launch/marketed products. Experience with digital/innovative publications and implementation to Omnichannel Scientific expertise in Cardiovascular and Diabetes is highly preferred Certification as a Medical Publication Professional (CMPP) highly desirable Understanding of clinical trial and real-world evidence study design and execution, statistical methods, and reporting requirements. Understanding of good publication practices and guidances (GPP3, ICJME), Sunshine Act, Pharma Code of Conduct, and other guidance related to data communication Demonstrated track record of managing multiple conflicting priorities in a rapidly evolving, fast paced, environment with successful outcomes. Familiarity with publication management tools and systems (iEnvision) ​ 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.
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    The US Scientific Communications team aims to support the development of high-quality medical publications to ensure clear, scientific communications of Sanofi data, enabling safe, appropriate use of and access to Sanofi medicines and to address unmet medical needs. JOB SUMMARY: The General Medicines Medical - US Transplant Publication Lead position, reporting directly to the Head, US General Medicines Scientific Communications and Medical Operations, will occupy a key leadership role by leading the strategic development, oversight, and delivery of US Transplant medical publications, with a focus mainly on Graft vs Host Disease. JOB DUTIES AND RESPONSIBILITIES: (Note: The list below is not comprehensive; this job is also responsible for other duties as assigned) Lead the development and oversight of strategic scientific publication plans and support the execution of operational and tactical activities within the overall medical communication platforms for assigned products, technologies, or services. Lead and own strategic US Medical Publication Plans for Transplant portfolio, ensuring robust strategic and tactical planning and implementation of congress presentations and manuscript execution in alignment with US and Global publications objectives and initiatives. Lead will oversee and/or manage publication projects, drive the recruitment/supervision of external agency partners, ensure timely delivery of tactics, collaborate with authors of peer-reviewed scientific publications to drive execution of planned publications, and understand corporate procurement processes and maintain responsibility for budgets and annual spend. Demonstrate an awareness of digital-driven publication and communication solutions that are emerging in the transmission of science and health information, incorporating solutions into strategic plans, as appropriate. Support evolving transformation of Omnichannel and support strategic development of customized HCP journeys. Also, individual will also collaborate to strategically support social media channel strategy. Collaborate closely with colleagues in US General Medicines Scientific Communications as well as cross-functionally within a matrix organization to ensure that information and knowledge transfer is conducted with internal and external stakeholders. Build effective partnerships with all stakeholders, including medical directors, statistical staff, clinical operations, field teams, HEOR, global publications, alliance partners, and CMO compliance/operations group Demonstrate innovation, creativity, and problem-solving skills. o Incorporate customer specific insights, gaps, and needs. Maintain transparency with peers and colleagues across the organization, to produce aligned strategy and tactics, while promoting synergy and avoiding duplication of effort. Sustain up-to-date working knowledge of all applicable prevailing guidance, regulation, and law that mandates the nature in which pharmaceutical organizations function. This may include but is not limited to documents prepared by FDA, OIG, DDMAC/OPDP, PhRMA, ICMJE, ACCME, etc. Ensure designated activities are appropriately executed, adherent to corporate SOPs and policies, and consistent with relevant external scientific, legal and regulatory standards. Performs other duties as assigned. REQUIRED SKILLS Ensure the successful achievement of goals, operating within all policies, procedures, and guidance to ensure compliance with SOPs and US CIA requirements, including transparency reporting. Managerial courage – ability to make difficult choices and implement successfully Strategic/critical thinking, problem solving · Innovative mindset to help evolve how publications are being created and disseminated Ability to work effectively in a rapidly evolving internal and external environment. Other responsibilities may include but are not limited to: national congress/association attendance as appropriate, planning meetings, leadership and management of publications projects and agency partners, various assigned team and cross functional working teams. Ability and willingness to maintain professional relationship with national and regional HCP authors, journals and publishers Outstanding interpersonal, written and verbal communication skills with exceptional time management skills are required for this role which requires strong cross-functional collaboration, teamwork, and stakeholder management LEADERSHIP SKILLS Plan, organize, and delegate effectively Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values and integrity to bring out the highest potential of each of our colleagues Advanced Degree: PharmD, PhD, or MD in a science subject or biomedical degree preferred. A minimum of 6 – 8 years of experience in the pharmaceutical or related healthcare industry experience A minimum of 4 - 5 years of publications experience in the pharmaceutical or related healthcare industry with expertise across all aspects of scientific publication strategy, planning, and execution during all phases of drug development and post-launch/marketed products. Experience with digital/innovative publications and implementation to Omnichannel Scientific expertise in Transplant is highly preferred Certification as a Medical Publication Professional (CMPP) highly desirable Understanding of clinical trial and real-world evidence study design and execution, statistical methods, and reporting requirements. Understanding of good publication practices and guidances (GPP3, ICJME), Sunshine Act, Pharma Code of Conduct, and other guidance related to data communication Demonstrated track record of managing multiple conflicting priorities in a rapidly evolving, fast paced, environment with successful outcomes. Familiarity with publication management tools and systems (iEnvision) ​ 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.
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    2nd or 3rd Shift ABOUT THE ROLE: Operate general manufacturing equipment under close supervision in accordance with current relevant quality standards or standardized procedures and within safety guidelines. Requires good documentation skills and attention to detail. Aseptic gowning in a classified work areas. Tasks to be completed may include formulation of bulk solutions, aseptic fills of syringes and vials under sterile conditions, filtration, vial and syringe preparation , and component staging. Operate general manufacturing equipment in strict accordance with SOPs to complete tasks as noted above, critical small or large volume sterile fills. Operate with minimal supervision complex systems and equipment and optimize their use in accordance with defined goals. May participate in plant trials for evaluating process modifications. Troubleshoot processing and equipment problems. Assist in the implementation of production procedures to optimize manufacturing processes. May provide training to new personnel in a specific technical process. Demonstrated ability in the application of requisite skills and applied additional skills and knowledge acquired through experience to perform the more complex tasks of the position. Generally receive no instructions on routine assignments while under little or no supervision. The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Requires physical demands of lifting up to 30 lbs/14 kg to 35 lbs/16 kg. The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions. May involve work with hazardous materials. Educational Qualification High School Diploma or GED. Basic Qualifications and/or Preferred Qualifications 3-5 years Pharmaceutical and clean room experience for the aseptic production of sterile products, is preferred; cGMP experience preferred. Strong content knowledge in CGMP/regulatory compliance. Gown certified. 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 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.
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    Job title: Regulatory Strategist (RS) Grade: (only for internal Job description) Hiring Manager: Global Regulatory Lead Location: multiple locations % Remote working and % of travel expected : NA Job type: Permanent, Full time Please note that this is a generic description of roles and competencies, some agility is required in reading and application About the job 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 Global Regulatory Team (GRT), and strategic partner to the Global Regulatory Lead (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. 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. Ensures 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 Ensures 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 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.
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    Sr. Project Manager Location: Bridgewater, NJ | Chatanooga, TN Remote Work: Hybrid (40% onsite, 60% remote) Job Type: Full time About the Job At Sanofi Consumer Healthcare, we have one shared mission – we work passionately, every day, to ‘serve healthier, fuller lives’ now and for the generations to come. In order to do so, we strive to act as a force for good by integrating sustainability along our business and employees’ mission and operate responsibly from both a social and environmental point of view. Everything we do is centered around people’s interests – our consumers, our customers, healthcare professionals, and our employees – across the world. We are building loved brands that serve 1bn consumers worldwide, through our key platforms: Allergy, Physical & Mental Wellness, Pain, Digestive Wellness and Cough, Cold & Flu. We aspire to become the best Fast Moving Consumer Health (FMCH) company In & For the world and we aim to build a work environment where people can thrive, grow, enjoy and be at their best. Main Responsibilities Project manager with End-to-End responsibility of innovation projects for global brands, leading a cross-functional team. The individual primary accountabilities are: Ensure all critical inputs (from different functions) are collected, clearly analyzed and discussed within the core and extended team. Manage project timeline and associated risks. Identify alternatives and drive the team to a recommended solution. Ensure each function is clear on required tasks and they deliver successfully. Ensure costs and financials are properly used in the decision-making process. Conduct launch readiness analysis​ with the cross functional team Drive open and clear communication within the team. Ensure required alignment before meeting with leadership team an/or stage gate. Effective lessons learned (projects + in-market performance). Timely update of information in required systems. Support portfolio management in business analysis. Organize project reviews and portfolio update at brand level. Coach project management on project execution and process improvements. Be a knowledge point for E2E project management execution and governance. About You Bachelor’s Degree. 7+ years of experience in project management in Consumer Healthcare or FMCG / FMCH company. Lead cross-functional team and set the pace for delivery​. Ability to understand requirements from the different functions. Manage ambiguity in a fast-changing environment. Strong ‘can-do’ attitude​. Persuasiveness & influence skills, highly collaborative with cross functional partners. Ability to manage several projects in parallel​. Good communication and partnership skills, including senior leaders. Ability to guide and mentor a team of project management Process improvement and challenging mindset aiming at simplification. Business focused and portfolio mindset. 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! #LI-SA #GD-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.
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    Project Manager Location: Bridgewater, NJ | Chatanooga, TN | Laval, QC Remote Work: Hybrid 40% onsite, 60% remote Job Type: Full time About the Job At Sanofi Consumer Healthcare, we have one shared mission – we work passionately, every day, to ‘serve healthier, fuller lives’ now and for the generations to come. In order to do so, we strive to act as a force for good by integrating sustainability along our business and employees’ mission and operate responsibly from both a social and environmental point of view. Everything we do is centered around people’s interests – our consumers, our customers, healthcare professionals, and our employees – across the world. We are building loved brands that serve 1bn consumers worldwide, through our key platforms: Allergy, Physical & Mental Wellness, Pain, Digestive Wellness and Cough, Cold & Flu. We aspire to become the best Fast Moving Consumer Health (FMCH) company In & For the world and we aim to build a work environment where people can thrive, grow, enjoy and be at their best. Main Responsibilities Project Manager with End-to-End responsibility on innovation projects for global brands, leading a cross-functional team. The individual main responsibilities are: Ensure all critical inputs (from different functions) are collected, clearly analyzed and discussed within the core and extended team. Manage project timeline and associated risks. Identify alternatives and drive the team to a recommended solution. Ensure each function is clear on required tasks and they deliver successfully. Ensure costs and financials are properly used in the decision-making process.. Conduct launch readiness analysis​ with the cross functional team Drive open and clear communication within the team Ensure required alignment before meeting with leadership team an/or stage gate. Effective lessons learned (projects + in-market performance). Timely update of information in required systems. Support portfolio management in business analysis. About You Bachelor’s Degree. 5+ years of experience in project management at Consumer Healthcare or FMCG / FMCH company. Ability to lead cross-functional team and set the pace for delivery.​ Ability to understand requirements from the different functions. Manage ambiguity in a fast-changing environment. Strong ‘can-do’ attitude​. Persuasiveness & influence skills, highly collaborative with cross functional partners. Good communication and partnership skills. Ability to manage several projects in parallel​. 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! #LI-SA #GD-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.
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    Maintenance Technician III The candidate should have the flexibility to work 3rd shift during Flu production season which run from June through August and 2nd shift during non-flu production season. This is not a 1st shift position. JOB RESPONSIBILITIES The candidate will work as a mechanic in a team environment to accomplish the following: Maintain and repair pharmaceutical equipment. Assist with the installation of pharmaceutical equipment. Perform changeovers and setup of pharmaceutical equipment. Perform preventative maintenance tasks as assigned by the electronic maintenance system. Comply with company policies, SOPs, cGMP and OSHA requirements. Ability to communicate and work constructively with other departments and teams. Demonstrate sound organizational, written and oral communications skills. Participate in deviation and root cause investigations as required. Utilize a CMMS to accurately document completed maintenance activities. Perform light carpentry, construction, and plumbing work (painting, spackling, bath fixtures) Perform safety inspection on ladders, eye wash, safety showers, fire hydrants, and roof BASIC QUALIFICATIONS: Be able to work a third (overnight) shift during Flu production season which run from June through August and work second shift during non-Flu production season. Position may also require some weekends, Holidays, and overtime. High School Diploma, GED, or higher with five (5) or more years of working experience in a maintenance capacity in a pharmaceutical or industrial manufacturing environment. PREFERRED QUALIFICATIONS: Experience with mechanical, electrical, and automated packaging equipment. Knowledge and experience with high speed syringe and vial filling equipment. Must be able to work as part of a team and work with minimal supervision. Clearly communicate issues and resolutions to management, peers, and other maintenance shifts. Able to understand basic mechanical and electrical concepts. Knowledge of pumps, motors, gear boxes, and drives. Proficiency in Microsoft Word, Excel, and Outlook. Be knowledgeable in LOTO, PPE, Confined Space Entry and Electrical Safety programs. Be able to wear all required safety equipment, i.e., safety glasses, hard hat, safety shoes and gloves, etc. Proficiency/experience in aseptic gowning. Knowledge of change control, Infor EAM CMMS, E-Beam, PLC, calibration. Be able to read electrical drawings, schematics, and P&IDs. Be able to fabricate parts on a milling/lathe mach. SPECIAL WORKING CONDITIONS: Must have a valid driver’s license in order to drive company vehicle to support off site building. Be able to wear all required safety equipment, i.e., safety glasses, hard hat, safety shoes and gloves, etc. Must be able to lift 50 lbs., climb stairs and work on a ladder. 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 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.
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    SUMMARY: The Associate Director, Compliance works within the Quality Assurance department and is responsible for overseeing Compliance, the Ridgefield Internal Audit Program, Inspection Readiness, GMP Training Program, Site Change Control Program as well as the Site Risk Management Program. JOB RESPONSIBILITIES Compliance · Coordinate and manage Regulatory and Sanofi GQA inspections · Coordinate, mange and develope Regulatory Agency inspection response plans · Oversee the timely closure of GQA and external audit responses and CAPA · Manage Site Internal Audit program · Oversee the site Data Integrity Program · Manage Site Inspection Readiness · Perform routine site Walk-thru inspection readiness inspections · Lead and support Quality Compliance programs (e.g. Data Integrity Plan, Quality Plan, etc.) · Lead and support initiatives for alignment to new regulatory requirements (e.g. EU MDR, MDSAP) · Coordinate gap analysis and implementation activities for the Corporate Quality Standards, Directives, and Global Operating Procedures including monitoring progress with status reports and metrics · Manage the Site Regulatory Intelligence communication process and Global Response Team site responses Training · Oversee the site GMP Training program including creation and execution of Annual Site Training plan ·Support the creation of site training plans for significant projects (e.g. product technical transfers) by working with cross-functional teams · Manage the Learning Management System (LMS) to ensure training requirements are defined in curricula and assigned to employees. Troubleshoot LMS issues · Compile and report learning metrics · Facilitate new hire GMP orientation, Annual GMP Refresher training, Train-the- Trainer training sessions and other instructor led training sessions as identified · Identify available training material from internal or external sources (i.e. computer- based learning, instructor led materials, job aids, supplier videos) and create training material as needed · Coordinate periodic reviews of employee learning plans and curricula · Lead and support Quality Culture initiatives (e.g. World Quality Week, site newsletter articles/contests) to encourage a Quality Mindset and patient focus Quality · Lead and support the Site Change Control Program · Lead and support the Site Risk Management Program · Maintain Site Risk Profile Report · Review/Approve changes to site documentation (batch records, test methods, protocols/reports, etc.) as necessary Leadership Qualifications: The Associate Director Compliance is expected to act on and demonstrate the Sanofi LEAD competencies and provide an ongoing commitment to conducting our global business according to the highest legal and ethical standards, and to continually pursue excellence in the development and delivery of all of our products and services. This includes: · Respect the laws and operating within the applicable regulations of the places in which we conduct business, as well as our own Company policies and procedures. · Act honestly and treat people with respect and courtesy. ·Constantly strive to make Sanofi a great place to work and a company respected for the quality of its people and products. ·Act as a role model for our fellow employees by acting responsibly, fairly, and honestly in dealings and exercising sound judgment. · Effectively communicate with individuals and within groups. Able to express ideas and thoughts clearly. Also understands that communication goes both ways: listens well and conveys a sense of openness and non-judgmentEffectively operate in an evolving, complex, and dynamic environment, and continuously looking internally and externally for best practices and areas for improvement. ·Perform as a versatile learner who is comfortable with complexity and ambiguity and a courageous decision maker who is candid and direct. HSE · It is required that individuals care for their own safety and wellbeing. Individuals must promote a safe working environment for employees and contractors working in their area of responsibility. · The individual must support all Sanofi and site HSE policies as well as ensure that work performed is compliant with local HSE regulations. ·Individuals must complete all required HSE trainings. Everyone is required to report all accidents and incidents and support investigations in their areas of responsibility. Individuals must ensure timely closure of HSE actions owned by their departments. REQUIREMENTS: · Bachelor’s degree in science or engineering and 10 years of experience in a GMP regulated environment or Master’s degree in science or engineering and 8 years of experience in a cGMP regulated environment · Minimum of 5 years of experience in supervisory/management role · Strong understanding of Good Manufacturing Practices and regulatory compliance Preferred Qualifications · Must be able to read and interpret complex documentation for compliance with procedures, standards, and regulations. · Demonstrated experience managing a regulatory complaince program 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. Identify available training material from internal or external sources (i.e. computer-based learning, instructor led materials, job aids, supplier videos) and create training material as needed Coordinate periodic reviews of employee learning plans and curricula Lead and support Quality Culture initiatives (e.g. World Quality Week, site newsletter articles/contests) to encourage a Quality Mindset and patient focus 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.
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    iShift - One ERP Program Sanofi is globally deploying its new back-office cross-functional and manufacturing system processes - covering Finance, SBS, Supply Chain, Trade, Manufacturing, Purchasing and Forecast, Maintenance, Quality and Warehouse Management across all GBUs - through the implementation of a Global ERP (iShift project) using SAP S/4HANA technology. This Transformation program aims at: - Enabling Global Business Units (GBU), Global Functions and Industrial Facilities with Analytics Common analytics by GBU and for Global functions to improve performance and cost management Transversal data consolidation as well as more granular analyses Common budget tools by GBU - Facilitating a seamless integration of planning and actual data setting-up automation in reporting to enable Global Shared Services (SBS) Support SBS strategy by implementing an end-to-end approach (e.g.: P2P fully covered by integrated Group solutions from eBuy to AP Invoicing, T&E, etc.) Opportunity to consolidate new activities in Shared Services (e.g.: Master Data Management, Credit Management) and to develop global Shared Services organization models (e.g.: T&E) Support reporting factories - Simplifying processes and Sanofi users’ experience State-of-the-art global systems ensuring an end-to-end process integration while providing a simplified user’s experience. Major changes to reporting or processes handled centrally at once. One source of truth on master data and a common automated internal control framework. Improved integration or divestment capabilities through a standardized methodology. JOB SUMMARY Being part of Solution Delivery Controlling team, he/she is responsible and accountable for the design and the deployment of a single technical solution covering Finance standardized processes in a single SAP solution for all businesses on all geographies. Domain covers Controlling Processes: Commercial Controlling, Industrial Controlling and related Group Reporting. He/she will bring his/her expertise of business processes and SAP solutions, best practices, and possible improvements. He/she will handle the delivery, for his/her Domain, of solution design and project deliverables for his/her Solution Delivery responsibility (SAP solutions design, implementation in the systems, all related documentation), for all projects he/she is contributing to, under the supervision and the support of the Solution Delivery Controlling Team Lead. He/she will insure within his/her perimeter and between the streams under his/her responsibility the overall consistency of the design proposed and related deliverables. MAIN DUTIES AND RESPONSIBILITIES In the context of the iShift Program, the main duties of the Solution Delivery Controlling team member: Ensure that risks and issues are identified, formalized & communicated to the Solution Delivery Controlling Team Lead. Ensure consistency of the solution for Domain and adherence to Standard and Core Model guiding principles (contribution to Design Authority) Contribute as Domain expert to AMS activities (project handover, L3 support & solution validation) Contribute as Domain expert to Integration topics with other domains Ensure Solution documentation & capitalization of knowledge; contribute to Knowledge transfer and upskilling as required; provide inputs & proposals for documentation templates & deliverable formats evolutions. Work with the Solution Delivery Controlling Team Lead to handle Escalations with SAP & relationship with Max Attention team for Domain Use correctly the Program Tools for Domain (JIRA, HPALM, …) Scoping Contribute to Scoping studies in collaboration with the Business enablement team. Provide workload estimations for new scope to be deployed for Domain, or new functionalities to be implemented as part of Continuous Improvement. Design of the Solution Lead, in collaboration with the Business Enablement team, the Global Design or Fit-Gap workshops to design the solution based on industry best practices, GBU & Global Support Functions business needs Propose adequate SAP solutions minimizing gaps with the SAP standard functionalities by challenging business requirements and specify for customizing and development the agreed solutions. Perform impact analysis for application changes for SAP and satellites applications. Collect and consolidate impacts for legacy systems Contribute to the design of transversal streams: (Master data management and migration strategy, Analytics, Authorizations, Process controls, Other Solution delivery Domain for integration topics) Collect and consolidate the information on Domain required for Infrastructure and application landscape definition Deliver all design deliverables defined by the program and under Solution Delivery responsibility (e.g.: Solution Documents, Functional specifications, Configuration documents …) Develop him/herself on the new capabilities provided by SAP S/4HANA on his/her perimeter; contribute to continuous improvement of the solution with POCs Development and testing Organize, complete, unit-test and document the configuration of the system Contribute with the development team to the specific developments (functional specifications update & inputs for unit test) Ensure quality of developments / Contribute to audits & quality KPI follow up Organize, document, and execute integration and system tests. Contribute to user acceptance tests and finalize the solution (address defects identified). Use properly the documentation and testing tools as defined by iShift Program. Complete all deliverables defined by the program and under Solution Delivery responsibility (e.g.: test protocols, test reports…) Migration and go-live Contribute to migration activities related to the stream Document and execute cut-over activities related to the stream Support the Business Enablement tram in updating training documents & contribute to trainings on the Solution Ensure go-live support and hypercare activities Handover to AMS: Lead the project transition to AMS for her/his functional domain (including knowledge transfer sessions and handover of ongoing incidents). AMS Contribute to AMS activities: provide functional expertise for complex topics and challenge / validate solution evolutions proposed by AMS team Cross- project activities Be the Referent Expert for specific topics within Domain: Provide ad-hoc support to projects during Design phase and validate evolutions. Maintain all reference documentation up to date Contribute to continuous improvement by keeping informed on new functionalities available for Domain & contributing to Proof of Concepts / Prototypes Contribute in improving the project industrialization with the aim to speed up the future iShift roll outs and Business Added Projects. KEY REQUIREMENTS Education Graduate studies (3 years): Bachelor’s degree in Finance, Bachelor’s in Supply chain, Bachelor’s degree in Science, Bachelor’s degree in IT or Engineering Professional Experience 5+ years of SAP experience Demonstrate a good track record in SAP design and customizing for modules related to Domain, preferably in a Pharmaceutical / Consumer Products industry. Very good general understanding of Domain business processes Operational experience in Domain area would be appreciated. Proofed experience working in major IT consulting firms as stream lead is considered a plus Previous working experiences in Sanofi is considered a plus Experience of SAP projects in complex and international environment Proofed SAP S/4 Hana knowledge is considered a plus At ease with Microsoft Office tools, and in general with IS tools. Knowledge and proofed experience in the Agile methodology is a plus Major Skills and Competencies Team player Strong oral and written communication skills; able to convince & federate Dynamic, results driven Rigorous & well organized Active listener, able to challenge requirements Accountability and Reliability Ability to evaluate risks & manage appropriate escalations MAIN INTERACTIONS Main Interfaces/Relationships: Internal: other iShift teams, Business (Finance/SBS, Supply chain), ITS partners and contributors (Application teams, ITS/IS, factories), AMS External: Implementation partner team, other partners, SAP 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.
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    Who You Are: The ideal candidate is a highly strategic, dynamic, and organized commercial leader who will drive strategy and execution across the U.S. Influenza Vaccine market. This person has a strong understanding of commercial marketing and sales activities coupled with deep understanding of the U.S. regulatory space and ability to manage through a complex operational and product delivery environment. The person will need to be able to create a superior customer and patient experience, as well as embedding Play to Win behaviors in all endeavors. You are motivational, energetic and a respected leader who brings the influenza vaccine strategy to life and engages the organization to adopt new ways of working to achieve the mandate of evolving the Go-To-Market model for Vaccines. You are a clear communicator, able to deliver key messages establishing both the “what” and the “why” with credibility. You are empathetic to understand what feasible given competing priorities and a “champion” is who rallies followership for the transformation through organizational influence. The Team: You will be joining the Adult Business Unit within Sanofi Vaccines and will work closely with teams across the U.S. and the Global Business. The leadership team shares the priority for creating a best-in-class high performing group driving the business forward. Job Highlights: Director, Flu Launch, Operations & Market Access – US Influenza Vaccines is a senior level marketing position with overall responsibility for strategy, execution, and performance of the entire Sanofi Influenza Vaccine portfolio. This includes marketed products Fluzone High Dose, Flublok, and Fluzone Standard Doese. With assets clinically proven to differentiate themselves vs. other available vaccines, it will be critical for this leader to develop, communicate and execute the overall strategy for the Sanofi Influenza Vaccine portfolio of products in the U.S. market. This individual will work closely with key teams across the organization including sales, thought leader liaisons (TLLs), market access, business operations, finance, medical affairs, regulatory, legal, compliance, global marketing, new product planning and supply chain. This individual will be responsible for the strategic direction and marketing execution of all influenza education and brand messaging to healthcare providers and patients. This role reports to the Senior Director, Flublok. This position will be based in Bridgewater, NJ. Sanofi US is only considering candidates who are currently legally eligible to work in the U.S. Company- paid relocation benefits will be provided for this position. Essential Job Duties and Responsibilities: Responsible for U.S. Influenza Flu Vaccine performance including unit demand, revenue, operating expenses and business operating income. Ensure cohesive customer experience from pre-book to in season pull-through.Develop and enhance brand strategic and tactical plans. Recommend and drive the alignment of resources and initiatives to achieve short-term and long-term brand and portfolio growth.Prioritize and manage marketing team’s work to ensure resources are focused on key initiatives from multiple stakeholder group. Works closely with Global Marketing to identify new product opportunities and management of global supply planning. Works closely with the Market Access team on pricing and contracting strategies and implementation Manage the annual pre-book and pull-through launch activities of Operations/Customer Service Support including:Prebook transactional emailsPackaging & Shipping materialsShelf talkersCommunications/talking points for field representativesDevelopment of promotional materials Market access liaison Contract AnnouncementsCD&A leadTraining of Direct OfferNon-Personal Promotion SupportVaxRatesByState.comPracticeENGAGECustomer Experience LiaisonAnalytics LiaisonUnites and contributes to the commercial team by communicating strategy establishing challenging goals, setting high standards and expectations, developing talented people, and recognizing outstanding contributions and indirect reports) to include but not limited to the following: ○ Annual objective setting ○ Coaching and counseling as appropriate Managing, directing & measuring work on an ongoing basis. Provides timely constructive feedback to ensure quality of work meets or exceeds company standards. Bring new ways of working and implementing agile approaches to enhance speed to market, execution iterations, and customer engagement within our digital strategy. Qualifications: A minimum of a bachelor’s degree is required. A minimum of 10 years’ pharmaceutical or vaccines experience in marketing is required. A minimum of 5 years of progressive leadership /people management experience is required. A minimum of 5 years of product management / marketing experience is required. Deep understanding of U.S. Regulatory is required.Strong understanding of Commercial Marketing and Sales is required.Experience with marketing strategy creation, strategic analysis and planning, project management Excellent interpersonal skills to negotiate, communicate, present, persuade a point of view. Ability to demonstrate the Sanofi Play to Win behaviors: Stretch, Take Action, Act in the interest of patients and customers, Sanofi First Excellent interpersonal, communication and presentation skills with the ability to interface seamlessly with other parts of organization.Exceptional leadership skills with proven ability to develop next generation leaders.Ability to work effectively in a matrixed, multi-cultural, global organization. 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. 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. #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.
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    Job Summary Reporting solid line to the CHC Digital Performance & Finance Manager, the CHC Digital NA Performance and Finance Lead is accountable to set, monitor & control digital product & services performance, value generation and financial controls. The role covers the following responsibilities: Explore continuous improvement & value opportunities. Generate CHC Digital performance metrics and monitor results. Drive performance efficiency through mobilization of functional teams. Focus on value generation by maximizing return of investment. Monitor & control financial goals following financial framework. Work with the regional and central teams on GSA management Businesses scope: Commercial Operations (sales and marketing), Industrial Affairs, Analytics, Science & Medical, Supply Chain, all support functions (FIN, HR, SBS, etc.) and infrastructure. Both global, regional, and local. Duration of assignment: Permanent Key Accountabilities Report and monitor the product & service performance. Support continuous improvement initiatives with functional teams. In charge of digital value generation monitoring from business point of view once the application is live (applications deployment, level of usage…) at regional / local level. Looking at the business / site health supported by applications (not application health). Identify use case for value generation (ex: global applications deployment to replace local ones, use case not covered by a digital tool…) Ensure roadmap at regional level is clear and align with central function objectives. In charge of financial / budget construction and landing securitization for this region. Ensure alignment in value generation tracking at global and local level. Support clearly both region and functions in their roadmap and finance management Ensure a coordination and synchronization of initiatives led by these teams. Strong connection and teams’ synchronization on regular and high frequency basis Education Bachelor’s Degree (B.A.) or equivalent. Preferred degree in Information Technology, Business or Engineering. Required Knowledge & Experience 5+ Years of experience in Digital / IT with proven skills in Service Management. Proven hands-on experience with managing IT processes, service levels and solution governance. Strong analytical, business acumen, finance, problem-solving and reporting skills. Ability to operate in complex matrix organization at high agility and global tasks forces with different digital stakeholders. Cultural traits / P2W Behavior Push to go beyond the level we have operated until now: constantly challenge the status quo focusing on the priorities that will deliver the best outcomes and letting go what won’t: be intolerant to mediocracy, believe we can and must do better and aim at higher but never at the expenses of our values and judgment. Put the interest of the organization ahead of own of those of his/her team: consider both short- and long-term impact of decisions; puts collective and global goals above individual or local goals; share resources and capabilities with those with the greatest need and impact; enable decision making at appropriate level. Taking action and don’t wait to be told what to do: take smart and informed best bets with the information at hand and anticipate the consequences of her/his actions; use personal judgement and others’ advice to make bold and impactful decisions which move us forward. Role model our 4 values: teamwork, integrity, respect, courage. Transversal Skills & Competencies: Business Acumen (intermediate) Business Partnership (intermediate) Transversal collaboration (intermediate) Problem-Solving (advanced) Language Fluent spoken and written English. 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.
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    Our Team This position will report into the US Medical Immunology team which is a segment of the Medical Affairs Specialty Care organization. Our Medical Affairs function serves as a valued strategic partner with Clinical, Commercial, Regulatory, and Market Access on therapeutic solutions to support patients’ needs. The US Medical Immunology team is proud to support Sanofi’s deep commitment to chasing the miracles of science to improve the lives of patients. Job Description This position reports to the Head of US Medical Immunology. Main job responsibilities Provide inspirational leadership to the US Medical Affairs Respiratory team (Medical Directors, Medical Science Liaison Managers, MSLs & Medical Operations Manager) by cultivating a culture of teamwork and collaboration to ensure the delivery of key priorities, while attracting, developing and retaining top talent. Lead the development and execution of an integrated Medical Plan (Medical Science Liaisons, Evidence Generation, Medical Education, Medical Communications and Publications, Health Outcomes, Safety and Clinical Research (Phase IIIB-IV and Investigator Sponsored Trials)) and annual budget for all respiratory products. Ensure strategic and cross-functional alignment across the organization to achieve the Medical mission of supporting safe and appropriate use of all respiratory products. Provide impactful medical strategy and expertise to Clinical, Commercial, Market Access and Regulatory partners. Provide medical review and approval of promotional and medical materials in compliance with corporate standards and government/industry regulations. Review, approve and supervise all aspects of US Phase IIIB - IV clinical study programs. Lead the review and approval of IST concepts/protocols according to applicable SOPs. Develop and maintain close professional relationships with Key Thought Leaders (healthcare practitioners and researchers) within the medical and scientific community. About you Education: Training in respiratory medicine preferred or advanced degree: MD, PhD Work Experience: Significant experience in Respiratory Medical Affairs Launch and Life Cycle Management activities preferred. Strong track record in developing and executing medical strategies in the US. Strong people management and development experience. Skills / knowledge: An entrepreneurial spirit with an executive presence. Knowledge of clinical development. Scientific acumen. In-depth understanding of the scientific method and ability to apply this information for business needs based on medical and scientific rationale. People Leadership. Ability to engage and leverage team members’ strengths. Set high standards and expectations, communicate proactively, collaborate and provide meaningful feedback, coaching and support. Relationships and Influence. Effective internal and external stakeholder management, politically astute and role model cross-functional teamwork and collaboration. Excellent skills working with experts from other functions and influencing decision making without authority in a complex matrix environment. Strategic thinking. Ability to disrupt status quo with innovation while remaining pragmatic and focused on priorities. Ability to translate innovative strategies or solutions into actionable plans. Result orientation. Driven to develop and execute optimal strategy meeting corporate objectives, while creating pragmatic solutions. Comfortable with ambiguity and ability to adapt with agility, take calculated risks and anticipate potential issues. 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 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.
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    Position Summary: Hours - Monday to Friday 7 AM - 3:30 PM Electrician Position will require a Massachusetts Journeyman Electrical License. Perform daily operations, maintenance and repairs on utility systems, manufacturing equipment and building systems in a highly regulated, 24X7, cGMP environment with little to no supervision. Core Responsibilities Performs Maintenance and repairs on all Electrical systems, Building Automation & Controls and PLC’S. Operate, troubleshoot of control systems and main electrical gear. Operate, troubleshoot and repair complex utility systems which may include WFI, RODI, Clean Steam, CIP, Autoclaves, Glassware Washers, production vessels, HVAC, Cold/Warm Rooms, MV and LV electrical distribution, control systems, compressed gases, plant steam/condensate, bulk chemical distribution and waste water treatment under little to no supervision. Interpret P&IDs, equipment/system layouts, wiring diagrams, and specifications in planning and performing maintenance and repairs. Write/revise accurate operational procedures, training documents and maintenance procedures for various utility systems. Supply information and technical data for securing spare parts. Provide responsive customer support with emphasis on customer satisfaction. Perform start up and commissioning activities, as required. Work in a collaborative team environment and interact with other support groups such as Engineering, Validation, Quality Assurance and Metrology. Perform preventative and corrective maintenance on manufacturing process related equipment within a cleanroom environment. Complete and provide accurate documentation, as required in cGMP operations. Oversee work and provide training of less experienced maintenance technicians and/or new technicians.      Basic Qualifications: High School diploma or GED Minimum of 7 years’ experience performing operations and maintenance on utility systems, HVAC systems and/or manufacturing equipment in a CGMP Biotech/Pharmaceutical manufacturing environment. Experience with current predictive maintenance technologies such as infrared thermography, vibration analysis and ultrasonic testing. Preferred Qualifications: Able to work in a dynamic, cross functional maintenance team supporting other functions which may include HVAC, utilities and process maintenance. Experience reading control schematics, loop diagrams, and P&IDs. Proficient computer skills utilizing MS Office suite applications, Building Management Systems, Distributed Control Systems (DCS) and Computerized Maintenance Management System (CMMS). Proficient written and verbal communication skills. Licensure any of the following areas: Waste Water Treatment, Refrigeration/Air Conditioning, Electrician, or Plumbing or Pipe fitter. Ability to train junior technician’s in a 1-1 setting in their trade specialty. Able to work independently under little to no supervision in a team environment. Special Working conditions: May require working in a clean room manufacturing environment including gowning. May be required to work 12-hour rotating shifts, which includes alternating weekends, and/or on-call work. (will require carrying an on call phone cycled through an on call schedule) Must be able to climb ladders. Must be able to lift up to 50 lbs. 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 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.
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    Job Summary Lead one or more indications/projects in Rare Disease or Rare Blood Disorder Therapeutic Area, under minimum supervision of senior statistical project leader or team leader. Major Duties and Responsibilities Lead a project /one or several indications of a project in rare disease and rare blood disorder clinical development. With minimum direction from senior statistical project leader or team leader, provide statistical support and scientific leadership for responsible projects. Accountable for statistical aspects of clinical development plans, studies and submissions activities (when applicable), including quality, relevance to external stakeholders (e.g. regulatory authorities, medical journals), and scientific validity. Mentor people working on the project. Promote teamwork, quality, operational efficiency, and innovation. Create productive work environment. Ensure project team compliance with SOPs and departmental standards. Plan and track project activities, timelines, and resource use. Provide justification for planned resource needs. Seek to optimize resource utilization through efficient and well-managed resource allocation and across projects or areas. Capacity to respond to unscheduled increase in project workload. Ensure productive collaborations with other functions in the aligned project team and with other statistics project leaders and in communicating with senior leadership. Represent statistics in cross function working groups. Contribute to operation process optimization and provide inputs to statistics standards. Required Education/Experience PhD/MS in statistics or related discipline with at least 6 years of pharmaceutical experience. Broad knowledge and good understanding of advanced statistical concepts and techniques. Proven experience in clinical development such as submissions, interactions with regulatory agencies or other external stakeholders. Demonstrated strong project management, interpersonal and communication skills. Experience in rare diseases or rare blood disorders preferred. 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.
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    JOB SUMMARY: We are seeking a highly motivated and talented Postdoctoral Researcher to join our Protein Engineering group within Sanofi LMR (Large Molecule Research) department to work on a novel mechanism of action for agonist antibodies. This position will work closely with experienced scientists in a dynamic, fast-paced, and highly collaborative environment. Our Protein Engineering group has a great track record of patents and publications. We have a state-of-art structural biology capability within the group, offering a unique opportunity to collaborate closely with protein engineers, structural biologists, and computational biologists. RESPONSIBILITIES: The successful candidate should have the expertise in the structural biology and yeast display-based antibody/protein engineering. Previous experience in the field of agonist antibodies for immuno-oncology therapeutic area is highly desired. The project will involve a combination of protein production, biochemical/ biophysical characterization, yeast display-based engineering, and structural biology analysis and techniques. The project will focus on expanding the recently discovered mechanism for agonistic antibodies to produce a generic platform modality through antibody engineering and structural biology. Design and perform structural biology experiments, such as X-ray crystallography and cryo-EM, to understand the mechanism of action of agonistic antibodies. Analyze structures and design structure-based mutations. Perform yeast display-based antibody engineering. Perform protein expression and purification, and biophysical/biochemical characterization of engineered antibodies, including ELISA, SPR, and mass photometry. Analyze and interpret data independently and communicate results to the team and stakeholders. Publish research findings in peer-reviewed journals and present at scientific conferences. REQUIREMENTS: Ph.D. in Structural Biology, Biochemistry, Molecular Biology, or related fields. Experience with structural biology techniques and protein/antibody design engineering is required. Experience with yeast display technology for antibody engineering is highly desired. Strong background in protein engineering, molecular biology, and protein purification is highly desired. Experience in the field of agonist antibodies for immuno-oncology therapeutic area is desired. Ability to work independently, design and execute experiments, troubleshoot technical issues, and analyze and interpret complex data. Excellent communication skills and ability to work collaboratively with other team members. Strong track record of scientific publications in peer-reviewed journals. 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.
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    About the Job: Our Team: In GQA, it is our mission to define the Sanofi Global Quality Audit process and to coordinate its implementation across the group. We are committed to provide an accurate, independent assessment of Sanofi M&S / R&D sites, country offices and key third parties for compliance with Sanofi Quality Policy requirements and applicable regulations through constructive audit and inspection support activities. We lead the external liaison group and manage our external relations to contribute positively to the development of regulations, guidance, policies, and initiatives that are external and relevant to Sanofi. We are change leaders that challenge the current processes against external benchmark and industry trends, to target the best-in-class audit process and organization. Main responsibilities: Leadership of the Global Quality Audit team. Provides direction and support for the GQA team for Sanofi site regulatory inspections Ensures close interaction with the Chief Quality Officer and Global Quality Senior Leadership team to ensure good governance of the GQA activities, audit findings and related CAPA. Interacts with Sanofi Internal Audit and Internal Control to identify and implement audit approaches that provide synergies and benefit to Sanofi. Implements Risk based approached and drives the transformation within GQ-Change management mind set role modelling play to win behaviours About You: Experience: FDA & external liaison advocacy expert Soft skills: risk-based decision making, relationship management, change management, transformation mind-set, empowering teams and leading by influence Technical skills: Regulations and golden standard auditing practices Languages: Fluent in English, French is a plus 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 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.
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    Senior Principal Scientist – Medicinal Chemistry DESCRIPTION: Integrated Drug Discovery (IDD) is the small molecule drug discovery platform within Sanofi. IDD is an international, interdisciplinary group that spans medicinal chemistry, structural biology, screening, biochemistry, biophysics, cellular pharmacology, delivery technologies, sample management and more. Our vision is to deliver valuable, high quality synthetic drugs of varying modalities to improve the lives of patients. Our mission is to provide innovation and key enabling technologies to drive the discovery of synthetic small molecules and emerging synthetic modalities as drug candidates in the Sanofi Research Portfolio; to deliver high quality science and innovative approaches to drug discovery, and to perform as a highly collaborative flexible and forward-looking organization with broad impact across the Sanofi pipeline. We are seeking a dynamic and experienced medicinal chemist to join our Cambridge, MA-based team as a Senior Principal Scientist. KEY DUTIES AND RESPONSIBILITIESThe successful candidate is a proven, experienced team leader with a track record of success in medicinal chemistry and multidisciplinary drug discovery. A Senior Principle Scientist is responsible for applying deep scientific expertise and judgement to initiate, design, and direct medicinal chemistry in support of research goals; is an expert in analyzing, interpreting and communicating scientific content to teams and stakeholders; demonstrates continuous growth in depth and breadth of scientific knowledge and understanding of strategic goals of group, team and company; successfully works as an impactful contributor, and as a leader of project teams and transverse initiatives; is an experienced and supportive manager and mentor of other medicinal chemists; has an established and growing reputation in the external scientific community through high impact publications, productive scientific collaborations and active participation in conferences. QUALIFICATIONS PhD in Organic/Medicinal Chemistry with 7+ years of experience in a pharmacuetical/biopharmapharmacuetical environment; or Master’s degree in Organic Chemistry with 9+ years of experience in a pharmacuetical/biopharmapharmacuetical environment; or Bachelor’s degree with 12+ years of experience in a pharmacuetical/biopharmapharmacuetical environment Exceptional technical skills and demonstrated ability to work and thrive in a collaborative cross-functional team setting; proven ability to analyze complex data sets, draw conclusions, and design follow-on experiments Experience in all phases of the small molecule discovery process from hit ID to candidate nomination Demonstrated track record of intellectual contributions in drug discovery as evidenced by impactful peer-reviewed publications, presentations, patents, and project achievements Strong interpersonal and communication skills (written and verbal) Experience in managing, coaching, and developing less experienced chemistry team members Experience working with CROs and external collaborators Comfortable and efficient in fast moving complex 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 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.
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    JOB DESCRIPTION: Sanofi Genomic Medicine Unit (GMU) CMC is dedicated to building best-in-class CMC technology and successful development of Sanofi gene and cell therapy programs that will bring cures to patients with unmet medical need. The Vectorology group within GMU CMC Predevelopment is responsible for the engineering of next-generation plasmids to improve the viral vector production platforms. We are seeking a highly motivated CO-OP student to join the team. The successful candidate will work with his/her supervisor to design, plan, and conduct molecular biology and cell culture experiments to investigate the impact of expression vector modification and/or host cell line engineering on recombinant AAV (rAAV) production. The successful candidate will have the opportunity to work both independently as well as part of the team to achieve group objectives. The candidate will have the opportunity to develop a diverse skill set in molecular biology and cell culture. Through this experience, she or he will gain knowledge of rAAV production platforms and optimization strategies. KEY RESPONSIBILITIES: Work with supervisor to plan, design and execute experiments, analyze data, and interpret experimental results. Conduct molecular biology assays such as, molecular cloning, plasmid preparation, quantitative PCR etc. Perform mammalian cell culture experiments like cell maintenance, cell transfection. Document laboratory experiments in a timely manner. BASIC QUALIFICATIONS: Currently enrolled in a molecular biology, cell biology or similar BS, MS or Ph.D degree program. PREFERRED QUALIFICATIONS: Experience with molecular biology, mammalian cell culture/aseptic techniques. Good organizational skills. Ability to use basic Microsoft office software such as Excel and PowerPoint. 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.
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    mRNA Associate Director, Drug Substance Platform Development - Vaccine In the race for the future of health– The Sanofi mRNA Center of Excellence (CoE) At Sanofi, we believe in a world in which no one suffers or dies from vaccine-preventable diseases. And while the pandemic has shaken up our industry, creating new opportunities and risks, we believe the acceleration of innovation with mRNA technology means vaccines for more people faster than before. That’s why we’re looking for bold, optimistic world-changers to join the team at our mRNA Center of Excellence. We’re investing €400m a year into the new Center, hiring a team of 400 dedicated employees for it and using it as the foundation to implement integrated end-to-end mRNA vaccine capabilities and research with R&D, digital and CMC teams. Bring your ambition and optimism for the future to Sanofi. About the Opportunity As an Associate Director within the Global CMC Drug Substance Development function, you will provide leadership to a group composed of scientists and engineers focusing on developing the next generation mRNA platform process within the mRNA CoE. The candidate will be responsible for designing and developing robust mRNA processes with stage appropriate control strategies from Phase 1 to approval. KEY RESPONSIBILITIES FOR POSITION About growing with us for winning with us In this role you will…. Build and lead a group of scientists and engineers to design and develop a scalable platform process for synthesizing and purifying mRNA drug substance Work with CMC Product Development & Industrialization team to develop processes that meet manufacturability requirements Develop plans to maintain, improve, and develop new competencies and assess resources (including personnel, facilities and equipment) necessary to meet current and future goals Coach and mentor direct reports to ensure continued development of platform competencies Establish criteria for measurable performance of the team and monitor with KPIs Deliver QbD based work packages to progress programs from pre-IND to approval including CQA definition, product and process design, characterization, and control strategy Ensure that platform is adhering to current regulatory practices and cGMP guidelines. Ensure safety of teams and compliance with good research practices, local and Global HSE/biosafety regulations Develop PAT for enhanced process monitoring and control. Actively participate and drive Sanofi’s position in conferences and scientific collaborations, with academia, industry, and regulatory agencies COMPETENCIES / REQUIREMENTS FOR POSITION About you Qualifications/ Education & Work Experience MS with > 13 years or PhD with > 7+ years of experience developing mRNA drug substance development Understanding of complex R&D landscapes globally, ability to identify cutting-edge technologies and new directions, strong academic and biotech/pharma scientific networks Experience leading multi-disciplinary teams Good oral communication, management, and interpersonal skills Results oriented, collaborative, decisive, strategic innovative thinker with passion for developing people Fluent in English Ability to travel domestic and international 10 – 20% 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 #mRNA 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.
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    Department Description Manufacturing Operations is responsible for supporting large scale mammalian cell culture and multi-stage large scale chromatography manufacturing operations as part of a 24/7 large-scale therapeutic protein or vaccine manufacturing facility. Operations’ main functions are leading deviation investigations and managing CAPA implementation, partnering with direct manufacturing staff for enhancing and improving the manufacturing instruction set, overseeing and supporting manufacturing’s training program, and identifying and managing continuous improvement initiatives. Senior Manufacturing Compliance Engineer uses expert knowledge of compliance and GXP manufacturing processes to manage investigation and improvement initiatives within manufacturing operations. Core Responsibilities Practices and promotes safe work habits and adheres to Sanofi’s safety procedures and guidelines. Manages cross functional team to drive complex investigation close outs, determine root cause and implement appropriate Corrective and Preventative Action. Utilizes manufacturing process knowledge and investigation skill sets to identify and resolve manufacturing issues, improve process operations and affect positive change. Conducts complex document revisions and /or document management including batch production records, manufacturing procedures, and cross functional procedures. Works with manufacturing managers and supervisors to develop and maintain training materials and curricula on process operations, theory and compliance. Trains new Manufacturing Compliance Engineers. Leads cross-functional continuous improvement teams with Engineering, Validation, Quality Assurance, Quality Control, Facilities, Metrology, and Manufacturing Technical Services. Works independently with minimal supervision and direction. Participates in determining objectives of assignment. Performs work that consistently requires independent decision making and the exercise of independent judgement and discretion. Effectively utilizes Microsoft office applications. Creates and presents trending and metrics reports. Provides direction to the Manufacturing Compliance Engineers in the absence of the operations manager. Understands concepts and applications of specialized or functional area, uses independent thought, analytical ability to achieve objectives that can impact the performance of standard resources that have been allocated through a plan or a budget. Compiles facts and diagnostics from a broad variety of sources (other functions/ internal stakeholders, customers, suppliers, regulators ...) to monitor the level of satisfaction or compliance associated with the delivery of products or services. Coordinates with others via teamwork and may provide technical or behavioral expertise and guidance to deliver results. Awareness of objectives of other functions and reacts quickly to recommend and promote efficient solutions or alternatives of complex issues. *Key Responsibilities may differ among employees with same job title and may change over time in accordance with business needs. Leadership Qualifications: An ongoing commitment to conducting our global business according to the highest legal and ethical standards and to continually pursue excellence in the development and delivery of all our products and services. This includes: Adhering to all applicable laws and regulations of the places in which we conduct business, as well as our own Company policies and procedures. Being honest and treating people with respect and courtesy. Constantly striving to make Sanofi's a great place to work and a company respected for the quality of its people and products. Acting as role models for our fellow employees by acting responsibly, fairly and honestly in our dealings and exercising sound judgment in performing our jobs Basic Qualifications Bachelor's degree in Sciences, Technical, Engineering or Advanced degree with 3-4 years in a cGXP manufacturing environment or a master’s degree in Sciences, Technical, Engineering or Advanced degree and 2 years of experience in cGXP manufacturing environment. Knowledge and understanding of Manfacturing. Knowledge of GXP regulations and guidance. Minimum of 2 years' experience with deviation management systems (e.g. Trackwise, Viva). Excellent critical thinking and technical writing Excellent written and oral English language skills. Proficient with change control requests, CAPAs and deviation quality systems Proficient in critical thinking and technical writing Experience leading cross functional teams and facilitating team meetings. Ability to influence in a cross-functional environment. Experience authoring and reviewing standard operating procedures, on-the-job-trainings and other controlled documents. Proficient in balancing the speed of delivering work with quality and shows commitment to make improvements in both aspects. Effectively tracks tasks related to deviations, CAPAs, or CCRs to ensure on-time adherence, and delivers results on time. Ability to work independently with minimal supervision to problem solve efficiently adhering to on-time delivery. Special Working Conditions Ability to gown and gain entry to manufacturing areas. Ability to work off shift hours, seldom, to support product release. 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 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.
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    Our Team: This position will report into the US Medical Immunology team which is a segment of the Medical Affairs Specialty Care organization. Our Medical Affairs function serves as a valued strategic partner with Clinical, Commercial, Regulatory, and Market Access on therapeutic solutions to support patients’ needs. The US Medical Immunology team is proud to support Sanofi’s deep commitment to chasing the miracles of science to improve the lives of patients. Job Description: This position reports to the MSL Regional Director, Resp & GI Non-Alliance Immunology. Main job responsibilities: Uses strong knowledge of relevant disease and disease management protocols, healthcare environment and competitors to articulate the medical and scientific value of our products with external stakeholders. Establishes robust, long-term peer relationships with Key Opinion Leaders and other stakeholder partners. Effectively utilizes the Scientific Engagement Model to plan territory and individual stakeholder (Key Opinion Leaders, HCPs, Payers) engagement interactions consistent with the Field Base Medical Activity Plan and medical function priorities. Critically and routinely evaluates information gained from published studies and stakeholder interactions to develop key insights that deepen our understanding of the market’s needs and opinions of external stakeholders, and therefore contribute to enhancement of medical strategy. Keeps abreast of medical and scientific developments in the therapeutic field to help identify and critically assess research opportunities, and plays a supportive role in the execution of evidence generation plans to enhance the value of our products in a real-world setting. Collaborates with our Clinical Studies Unit to support clinical trials. Responds to unsolicited requests regarding interest in investigator sponsored studies (ISS), and supports ISS submissions through appropriate internal processes. Organizes educational meetings or local scientific advisory boards when requested. Supports speaker training. Responds to unsolicited requests for medical information associated with supported products and disease state area. About you List the requirements that are ideally required to be qualified for the position. Remember, the fewer the restrictions, the easier it is to expand the talent pool and increase the diversity of candidates. Education: MD, PhD, PharmD preferred. Work Experience: Previous MSL experience in dermatology preferred. Skills / knowledge: Ability to interpret key scientific data and translate this information to meet educational and research needs. Utilizes effective, professional communications to cultivate strong working relationships with internal partners and external stakeholders. Exemplary presentation skills with ability to distil complex data into a simple and impactful story. Demonstrates scientific expertise - stays abreast of data, treatment trends, and new information in the therapeutic area. Ability to translate expert feedback into appropriate insights. Proficiency with digital tools. ​ 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. 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 #IMM2023 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.
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    HEOR Director - Rare Disease Purpose of Role: To support rare disease portfolio to plan and generate robust evidence to maximize the value propositions from both a global and US perspectives working within the market access team. Major Activities / Key Responsibilities Health Economics strategy, evidence generation and reimbursement support Oversee and guide development of quality research projects, economic models, trial design recommendations and other activities in support of programs/products . The incumbent interfaces with Clinical, Medical Affairs and business partners including Marketing, External Affairs and Market Access. He/she is accountable for the overseeing direct report at director level on product launches and post launch evidence generation activities. The incumbent will also lead planning, design, implementation and completion of innovative evidence based research programs that are consistent with program/product strategies. The research programs developed will provide appropriate evidence and/or tools to be used for internal decision making and for external audiences at product launch and over product life cycle. (Note: The list below is not comprehensive; this job is also responsible for other duties as assigned). Minimum requirements within this job function: Develops strategies and provides new ideas and concepts on how to move the program, product or therapeutic franchise forward Manage the HEVA evidence generation strategy Manage team budgets and execution of ongoing studies according to budget and timeline expectations Identify new HEVA evidence generation opportunities to maximize lifecycle management Assist countries in developing or adapting health economic models and other materials for reimbursement, payer objection handling and other purposes Develop and maintain effective relationships with key internal stakeholders including North American Medical Affairs, European Medical Affairs, Sanofi Emerging Market regional teams, and Established Products. Sets strategic evidence generation priorities and direction for assigned responsibilities and is able to incorporate this into appropriate planning documents Takes a leadership role in the development of relationships and continued advocacy with external advisors in appropriate therapeutic areas. Develops collaborative research relationships that provide data of value to decision makers. Leverages interactions to identify strategies that will improve the impact of research and build advocates for data. Interacts with senior level management providing high level strategies and long term vision of assigned work. Implementation of evidence generation tactics consistent with HEVA strategic goals including designing, budgeting, contracting, tracking, reporting, and publication plans Provides input to clinical and medical teams regarding opportunities to execute HEVA strategies within their planned research activities by identifying the appropriate evidence to collect and report. Serves as a resource to commercial organization in terms of pricing, positioning and reimbursement of products based on economic evaluations. All incumbents are expected to demonstrate effective communication, organizational and interpersonal skills to be able to work effectively as part of a multidisciplinary team. The incumbent is expected to work independently, but in concert with the direction provided by their management, in accordance with defined functional policies and precedents, budgetary guidelines, company values, ethics and applicable law. 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 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.
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    Position Overview Reporting to Global Head of Translational and Nonclinical Biostatistics (TED) under Global Biostatistical Sciences (GBS) in Sanofi Vaccine Business, the Head of Nonclinical Biostatistics is responsible for the statistical oversight of activities in clinical assay characteristics/qualification/validation for late phase clinical testing of immunogenicity/antibody responses; CMC analytical science for drug products and drug substance assay statistical strategies in design and validation/qualification. Responsible to provide statistical expertise in responding to regulatory questions in clinical studies related to clinical assay testing. In addition, ensure the outsourced assay activities are aligned with Sanofi standard and regulatory requirements. People’s management of direct reports. Key Responsibilities: Key interface with internal and external stakeholders for below statistical support: Clinical testing Internal (late phase clinical testing); lead the statistical activities in assay development, qualification, validation and testing to ensure the science, quality and compliance. Responsible for regulatory response and medical journal submissions. Clinical Testing External; lead the stats contents when applicable in assay development, qualification, validation and testing to ensure the science, quality and compliance at CRO. Responsible for regulatory response and medical journal submissions when applicable. Research Assay development; Provide stat support to research assay development and qualification. Responsible for regulatory response and medical journal submissions when applicable. Provide statistical support for external lab evaluation and activities relate to outsourcing (qualification, bridging, concordance, etc.) Support new technologies for testing and diagnostics: Provide statistical support on bioassay, biomarker, diagnostic, serology testing, etc. External collaboration: represent Sanofi in external collaborations, e.g., IMI consortiums, industry standard and white paper when involving new technologies related to testing and diagnostic assay. CMC support: Lead the statistical support of analytical method development and qualification/validation to ensure science, quality and compliance. Responsible for regulatory response and medical journal submissions. Design of Experiment (DoE) application and training: apply statistical and modern experimental techniques to improve assay efficiency and to improve existing processes by identifying and reduce source of variabilities. Develop and deliver statistical training materials as well as software tools for scientists. People’s management responsibilities including line management, coaching, mentoring, empowering and performance review for direct reports. Manage and mentor direct reports with technical supervisions/inputs including project assignments, review statistical analysis plan and report; workload tracking and managements. Set up objectives and development plans with individual staff members and provide on-going mentoring and guidance. Continue to build team, coach and empower staff to allow them to reach their full potential to best support projects. Performance evaluation of direct reports according to HR guidelines. Create a supportive and stimulating working environment. Working with other TED and GBS Lead, manage employees in a matrix organization (if employee works across functions) Hiring, and managing new staff when needed. Advocate sound statistical principles Educate scientists to apply the sound statistical principles in study conducts including design, data handling, analysis and reports to increase the success rates moving the programs to clinical stages. Develop and deliver statistical trainings to scientists. Continuous improvement of the preclinical biostats platform to make it a high performing organization Focus on company goals to identifies areas for improvement in both projects and operational aspects and proposes initiatives to address challenges. Contributes to GBS and TED initiatives from preclinical perspectives to make the organization highly efficient. Communicates nonclinical vision and strategy, and supports employee involvement in departmental activities Requirements Education, Experience and skills: A Ph.D. or MS in statistics/biostatistics or related discipline with at least 8-10 years of pharmaceutical experience in related areas. Broad knowledge and good understanding of statistical techniques and regulatory requirements in clinical assay and diagnostic testing. Managerial experience in leading a team to support global functions is desired. Demonstrated strong project management skills and multitasks under time pressure. Effective communication skills Excellent English writing skills in responding to internal and external reviews. Ability to meet the regulatory standard when document the statistical sections. Ability to represent Sanofi in cross-company activities such as consortiums or professional associations. 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.
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    Senior Principal Scientist, Preclinical Safety Projects, US Job Overview and Responsibilities: This position will provide the department of Preclinical Safety a wide range of support associated with Toxicology and Safety Pharmacology needs on Discovery and Development Project Teams of Sanofi Group. This position would provide toxicology scientific expertise across the drug discovery and development value chain on biotherapeutics and small molecules. Activities include, but are not limited to: Serve as Preclinical Safety project team representative on multi-disciplinary Discovery and Development teams responsible for the progression of both biotherapeutics and small molecule compounds for regulatory submissions. These activities include designing and coordinating a multi-disciplinary effort to support such projects through the development of the nonclinical safety strategy and program which includes, but is not limited to attending various project team meetings; the design and interpretation of toxicity studies; the preparation and/or review of written safety pharmacology and toxicology reports; and the authoring of the nonclinical document sections for regulatory submissions (including CIBs INDs, MAAs, CTAs, CTDs and BLAs) Interact with multiple functions (Pharmacology, Regulatory Affairs, Clinical, Project Leaders & Managers, etc.) on a daily basis Participate in issue-resolution teams, where she/he will be required to contribute to hypotheses generation and drive the science for toxicology issue resolution in drug discovery and development. Participate in Preclinical safety-US and global Preclinical safety Department activities (staff meeting, scientific forums, etc.), and special projects Participate in special projects or inter-industry working groups, as needed. Provide scientific input on design and analysis of research activities Serve as internal expert for scientific issues related to nonclinical safety issues Ensure high scientific standards and adhering to requested timelines in all aspects of the position Basic Qualifications: PhD in toxicology, pharmacology, immunology or related disciplines and two years of post-doctoral experience At least 5-8 years of relevant Toxicology experience Authoring of the nonclinical document sections for regulatory submissions (including CIBs INDs, MAAs, CTAs, CTDs and BLAs) Knowledgeable about GLP policies and/or regulatory nonclinical testing requirements for pharmaceutical development of biotherapeutics and small molecules Excellent verbal and written communication skills Demonstrate leadership and expertise in preclinical safety disciplines Preferred Qualifications: The candidate should have knowledge in biochemistry, toxicology, pharmacology, Immunology, physiology, and statistics. DABT certification is preferred, but not required. Experience as a GLP Study Director is preferred. Location Information: The successful candidate will report to the Head of Preclinical project in the US This position is based in Cambridge, MA. 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.
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