
Senior Medical Content Specialist
2 days ago
Job Description
">- Compiles, writes, edits, and coordinates medical writing deliverables that present scientific information clearly and accurately.
- Works as a medical writer within and across departments with minimal or moderate supervision.
- Completes various documents including clinical study protocols, reports, patient narratives, annual reports, and more.
- Adheres to established regulatory standards, ICH E3 guidelines, company SOPs, client standards, and approved-templates.
- Coordinates quality and editorial reviews, ensures source documentation is managed appropriately, and resolves comments from clients.
- Serves as peer reviewer for internal team to ensure document scientific content, clarity, overall consistency, and proper format.
- Reviews statistical analysis plans and table/figure/listing specifications for appropriate content and grammar.
Requirements
">- Bachelor's degree in a relevant field with relevant writing experience; graduate degree preferred.
- At least 2 years of relevant experience in science, technical, or medical writing.
- Experience working in the biopharmaceutical, device, or contract research organization industry preferred.
- Familiarity with FDA and ICH regulations, other regulatory guidelines, and/or good publication practices strongly preferred.
- Ability to write relevant document types and possess extensive knowledge of English grammar.
Benefits
">- Interacts and builds good working relations with clients, department heads, and peers.
- Performs online clinical literature searches and complies with copyright requirements.
- Mentors less experienced medical writers on projects.
- Maintains a strong working knowledge of drug development process, regulatory guidelines, industry standards, and best practices.
- Aware of budget specifications for assigned projects.
Additional Responsibilities
">- Performs other work-related duties as assigned.
- Complies with copyright requirements.
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