About this role
Role Overview
- 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 and amendments, clinical study reports, patient narratives, informed consents, and more
- Adheres to established regulatory standards
- Coordinates quality and editorial reviews
- Leads team document reviews
- Acts as peer reviewer for internal team to ensure document scientific content and clarity
- Provides feedback to further define statistical output
- Interacts and builds good working relations with various departmental heads and peers
- Performs online clinical literature searches
- Identifies and proposes solutions to resolve issues
- Mentors and leads less experienced medical writers
Requirements
- 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
- career development and progression
- supportive and engaged line management
- technical and therapeutic area training
- peer recognition
- total rewards program