Senior Medical Writing Analyst (Remote) - California, Virtual Address

Work Flexibility: Remote

We are currently seeking a Senior Medical Writing Analyst (Remote) to support our Sports Medicine Business Unit, part of the Stryker Endoscopy Division, to be based remotely anywhere within the United States.  Our Sports Medicine team delivers a wide range of innovative sports medicine implants, instrumentation, resection and biologic solutions, focusing on minimally invasive and open approaches to the shoulder, knee, hip and small joints.

Who we want

• Dedicated achievers. People who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations. 

• Self-directed initiators. People who take ownership of their work and need no prompting to drive productivity, change, and outcomes.

• Meticulous documenters. Detail-oriented people who enjoy maintaining meticulous documentation of reports, metrics, proposals, and presentations. 

• Data translators. Highly effective communicators who can transform data findings into recommendations to compose reports and executive level presentations. 

• Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, data and insights to drive continuous improvement in functions.

What you will do

As the Senior Medical Writing Analyst (Remote) you will be responsible for creating clear, accurate, and regulatory-compliant documentation related to clinical submissions. Your primary role involves translating complex scientific and technical information into accessible content for various audiences, including, regulatory bodies. You will work closely with cross-functional teams (Medical Writer, Regulatory, Clinical, Quality, Marketing) in the preparation of clinical documents such as clinical evaluation documents and Post Market Clinical Follow-up documents for both periodic updates and new products.

• Perform formal literature searches, and succinctly summarize scientific content for assigned projects.

• Participates in post-market surveillance activities by conducting routine systematic literature reviews (e.g. screens articles against inclusion/exclusion criteria, extracts data from included studies, interprets study results, synthesizes literature, and prepares summaries into formal reports) for specific medical device groups or sub-groups.

• Author integrated safety/performance data summaries including Clinical Evaluation Plans and reports, PMCF Plans and reports, summary of effectiveness and safety from raw data or summary tables.

• Leads the scoping of clinical evaluation documents which includes alignment of information between the clinical evaluation and its various input documents such as technical documents, instructions for use and risk management files.

• Able to think analytically, have the ability to interpret data from scientific literature and clinical studies and synthesize the results and in a clear, concise, and scientifically accurate manner in the clinical document.

• Independently resolves document content issues and questions from external and internal reviewers and ensures timely approvals from all reviewers.

• Assist in the maintenance of the Stryker Endoscopy library for all relevant literature.

• Assist in the development of internal procedures, templates and style guides.

• Recognize potential scheduling and resource conflicts for projects and provides recommendations to resolve.

• Provide clinical science subject matter expertise and consultation to Clinical Research Associates, Biostatistics, Data Management, Regulatory Affairs, Clinical Safety and other internal and external stakeholders.

• Collaborate with other staff to resolve complex or unclear situations. Propose and participate in departmental continuous improvement initiatives. 

• Work and make independent decisions and be able to take the initiative to lead projects and assignments.

• Plan, organize, and implement multiple concurrent tasks.

What you need

• Bachelor’s Degree required, preferably in a Scientific Discipline.

• Master’s or Ph.D. or other higher degree in health-related field (RN, BSN, BPharm/MD/MPH) preferred.

• Minimum of 2+ years of experience in clinical or healthcare related field is required.

• 1+ year of experience in Scientific or Medical Writing, relevant academic or clinical research experience (PhD, Post-doc) is required. 

• Understanding and experience in the use of scientific journals, publication guidelines, databases, search strategies, literature management software.

• Knowledge and experience with MEDDEV 2.7/1 Rev. 4,  EU Medical Device Regulation 2017/745 (MDR) and MDCG compliant clinical evaluations and clinical study documents preferred.

• Technical aptitude and attentiveness to detail.

• Knowledge in clinical operations, risk management, regulatory submissions and US and international guidelines preferred.

$75,300.00 - $156,900.00 salary plus bonus eligible + benefits. Actual minimum and maximum may vary based on location. Individual pay is based on skills, experience, and other relevant factors.

Travel Percentage: 10%

Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability.

Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.