We are seeking a strong REMOTE Technical Writer.
A minimum of 5 years of clinical or industry experience preferably supporting activities in clinical research, medical affairs or similar experience in a medical/scientific area is required. More requirements listed below.
USDM Life Sciences is a leading global consulting firm focused on life sciences, specializing in regulated business processes, with an emphasis on compliance and performance.
APPLY ONLINE: USDM WEBSITE
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.
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.
Experience: A minimum of 5 years of clinical or industry experience preferably supporting activities in clinical research, medical affairs or similar experience in a medical/scientific area is required. Education: Bachelors/Masters in a scientific/technical discipline or equivalent; advance degree (M.S., Ph.D.) desired, experience in pharmaceutical, biological, or medical device development , Experience writing regulatory submissions such as NDAs/INDs,BLAs , Strong knowledge of FDA, ICH, ands GCP guidelines, Regulatory/Clinical writing experience.