Regulatory Affairs Manager III

eTeam; Raynham (MA); Hybride; USD 80 000 - 110 000; Plein temps

Résumé du poste

A leading medical device company is seeking a Medical Writer Specialist to prepare regulatory documents and conduct scientific writing. This role demands a Ph.D/Pharm D or an equivalent degree with 1-2 years of relevant experience, or a BS/B.Pharm/BSN/MS/MPH with 4-5 years. The candidate should have excellent writing skills, knowledge of clinical research, and proficiency in Microsoft Office Suite. The position is based in Raynham, MA, with options for remote work for experienced professionals.

Qualifications

• Ph.D/Pharm D in medical writing or related field.
• 1-5 years of medical device/drug industry experience.
• Expertise in clinical research, regulations, and scientific writing.

Responsabilités

• Prepare, write, edit, and review regulatory documents.
• Conduct literature reviews for post-market activities.
• Perform scientific writing, including abstracts and manuscripts.
• Ensure documents follow internal and external guidelines.
• Communicate with various departments for information.

Connaissances

Excellent writing and proofreading

Project management

Strong oral communication

Interpersonal skills

Formation

Ph.D/Pharm D plus 1-2 years experience or BS/B.Pharm/BSN or MS/MPH plus 4-5 years experience

Outils

Microsoft Office Suite

Bibliographic software (e.g. Endnote, Reference Manager)

Description du poste

eTeam was formed in 1999 with the goal of becoming the supplier of choice for clients, employees and contingent workers. Today, we’re one of the fastest-growing companies in New Jersey and ranked as one of the best companies to work for by Staffing Industry Analysts and New Jersey Business. We’re also an honored member of Deloitte’s Technology Fast 50.

Job Description

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 database reviews.
• Communicates with various departments (e.g. Regulatory, Product Development, Clinical Research, Quality) to identify the necessary clinical and technical information.

Qualifications

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

• 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).