Medical Writer II – Senior Medical Writer
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Job Description
Senior medical writer coordinating and managing content for clinical and regulatory documents in biopharmaceutical settings. Collaborating with clients and teams to ensure high-quality deliverables.
Responsibilities:
- Writes, edits, and coordinates content for clinical/regulatory documents
- Leads the clear and accurate completion of medical writing deliverables
- Manages medical writing activities associated with individual studies
- Completes a variety of documents that may include clinical study protocols, clinical study reports, patient narratives, annual reports, investigator brochures, informed consents, and more
- Leads the resolution of comments from the client
- Acts as peer reviewer for internal team to ensure document scientific content, clarity, overall consistency, and proper format
- Interacts and builds good working relations with clients, department head, and peers in data management, biostatistics, regulatory affairs, and medical affairs
- May contribute to development of internal materials and presentations or changes to internal process, standard practices, and capabilities
- Mentors and leads less experienced medical writers on complex projects
Requirements:
- Bachelor’s degree in a relevant discipline with relevant writing experience; graduate degree preferred
- 3-5 years of relevant experience in science, technical, or medical writing
- Experience working in the biopharmaceutical, device, or contract research organization industry required
- Strong understanding of FDA and ICH regulations, other regulatory guidelines, and/or good publication practices strongly required
- Experience writing relevant document types required
- Extensive knowledge of English grammar and ability to communicate clearly; strong familiarity with AMA Manual of Style
Benefits:
- Health benefits to include Medical, Dental and Vision
- Company match 401k
- Eligibility to participate in Employee Stock Purchase Plan
- Eligibility to earn commissions/bonus based on company and individual performance
- Flexible paid time off (PTO) and sick time
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