Job Description

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 European law (i.e. Medical Device Directive (MDD), a.k.a. 93/42/EEC), procedures, internal and external guidelines (e.g. MEDDEV 2.7.1) – this is a key guidance document that I did not see once on the resumes, 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 side is minor & potentially negligible need in this business unit) 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. (European) Regulatory, Product Development (typically bioengineers or mechanical engineers), Clinical Research, Quality) to identify the necessary clinical and technical information.

Job Qualifications

Education
• Ph.D plus 1 to 2 years of related medical device experience (e.g. medical writing, regulatory affairs, clinical research, engineering)

• BS/BSN or MS plus 4 to 5 years of relevant medical device industry experience

Knowledge/Requirements

• Excellent English language skills, especially writing and proofreading.
• H1B Sponsorship available
• 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).