Regulatory Affairs Manager III

The Medical Writer Specialist is responsible for preparation of documents that support the presentation and/or publication needs of assigned therapeutic areas and/or medical devices in the DePuy Synthes Strategic Medical Affairs Team for a wide range of audiences. Key Job Activities:

• Primarily focuses on preparing, writing, editing, and reviewing regulatory (e.g. Clinical Evaluation Reports (CERs), clinical data reports or summaries) documents and responses to regulatory authorities (e.g. notified bodies).
• 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.
• Performs scientific writing (e.g. abstracts, manuscripts, presentations).
• Organizes and incorporates information for documents, such as references, graphics, tables, and data listings.
• Ensures documents are produced in accordance with procedures, internal and external guidelines (e.g. MEDDEV 2.7.1), and electronic templates.
• Ability to quickly acquire understanding of therapeutic areas, medical device portfolios, business objectives, clinical data/evidence
• Independently, critically writes and edits scientifically complex documents for substantial intellectual content.
• Reviews and provides input on clinical data being considered for presentation and/or publication to ensure alignment with scientific strategies and corporate goals.
• Expert knowledge of clinical research, device/drug development processes, regulatory requirements, good clinical and data management practices.
• Ability to understand and interpret statistical results of clinical studies; specifically summarize complex results and present them in clear, concise, and scientifically accurate manner to various end users.
• Performs MAUDE data base reviews
• Communicates with various departments (e.g. Regulatory, Product Development, Clinical Research, Quality) to identify the necessary clinical and technical information.

• This position is located in our corporate offices in Westchester, PA or Raynham, MA or remote (for experience professional).

• Ph.D/Pharm D plus 1 to 2 years of related medical device/drug industry experience (e.g. medical writing, regulatory affairs, clinical research, engineering)
• BS/B.Pharm/BSN or MS or MPH plus 4 to 5 years of relevant medical device/drug industry experience Knowledge/Requirements
• Excellent English language skills, especially writing and proofreading.
• Clinical, scientific or research background, highly preferred.
• Experience writing CERs, highly preferred.
• Knowledge in narrative or systematic literature reviews (e.g. PRISMA, Cochrane), highly preferred.
• Experience in medical writing or demonstration in scientific writing ability in accordance with International Committee of Medical Journal Editors (ICMJE) authorship guidelines, preferred.
• Expert understanding of scientific or clinical research and methods.
• Understanding of statistical data and good data management practices.
• Strong oral communication, presentation, project management and prioritization skills.
• Excellent interpersonal relationships.
• Highly proficient in Microsoft Office Suite and bibliographic software (e.g. Endnote, Reference Manager).

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