Senior Medical Writer – FSP

This is a fully remote position, open to applicants in United States, +2 more locations.

📋 Description

• Oversee the precise and effective production of medical writing outputs.

• Manage the medical writing tasks linked to specific studies and facilitate coordination among various departments.

• Lead the resolution process for client feedback.

• Prepare clinical study protocols, protocol amendments, clinical study reports, patient narratives, annual reports, investigator brochures, informed consent forms, plain language summaries, periodic safety update reports, clinical development plans, IND submissions, integrated summary reports, NDA and eCTD submissions, journal manuscripts, abstracts, posters, and presentations.

• Comply with ICH E3 guidelines, company standard operating procedures, client specifications, approved templates, authorship obligations, and style and formatting manuals.

• Coordinate quality assurance and editorial reviews while managing source documentation.

• Lead team document evaluations and serve as a peer reviewer.

• Review statistical analysis plans and specifications for tables, figures, and listings.

• Establish productive relationships with clients and cross-functional teams in data management, biostatistics, regulatory affairs, and medical affairs.

• Conduct online searches of clinical literature and ensure adherence to copyright regulations.

• Identify and suggest solutions, escalating issues as necessary.

• Offer technical support, training, and advice.

• Mentor and guide less experienced medical writers on intricate projects.

• Cultivate expertise in industry topics and regulatory standards.

• Monitor budgeted hours and communicate updates and changes to medical writing leadership.

• Fulfill administrative responsibilities and other assigned tasks.

⛳️ Requirements

• 3-5 years of pertinent experience in scientific, technical, or medical writing.

• Experience within the biopharmaceutical, medical device, or contract research organization sectors is essential.

• Strong understanding of FDA and ICH regulations, additional regulatory guidelines, and/or best publication practices is critical.

• Proven experience in drafting relevant document types is required.

• Extensive knowledge of English grammar and the ability to communicate effectively.

• Strong familiarity with the AMA Manual of Style is necessary.

• Minimal travel may be needed (less than 25%).

🏝️ Benefits

• Opportunities for career development and advancement.

• Supportive and engaged line management.

• Training in technical and therapeutic areas.

• Peer recognition and a comprehensive rewards program.

• An inclusive workplace culture.

• Company vehicle or car allowance.

• Medical, dental, and vision health benefits.

• Company-matched 401k plan.

• Eligibility to participate in the Employee Stock Purchase Plan.

• Opportunity to earn commissions or bonuses based on both company and individual performance.

• Flexible paid time off (PTO).

• Sick leave.

• Reasonable accommodations provided as appropriate.