Senior Medical Writer – Sponsor Dedicated, CSR, Protocols, IB, Reg Documents

This is a fully remote position, open to applicants in United States.

📋 Description

• Oversee the precise and thorough completion of medical writing deliverables.

• Manage medical writing tasks for specific studies with minimal oversight.

• Coordinate medical writing efforts within and between departments.

• Facilitate the resolution of client feedback.

• Prepare clinical study protocols, protocol amendments, clinical study reports, patient narratives, annual reports, investigator brochures, informed consents, 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 SOPs, client standards, approved templates, authorship requirements, and style and formatting guides.

• Organize quality and editorial reviews and manage source documentation.

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

• Evaluate statistical analysis plans and table/figure/listing specifications.

• Collaborate with clients and teams in data management, biostatistics, regulatory affairs, and medical affairs.

• Conduct online clinical literature searches and adhere to copyright requirements.

• Identify and address issues, escalating as necessary.

• Provide technical assistance, training, and consultation.

• Contribute to internal materials, presentations, processes, standards, and capabilities.

• Mentor and guide junior medical writers on complex projects.

• Develop expertise in industry topics and regulatory requirements.

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

• Complete administrative tasks and other assigned duties.

⛳️ Requirements

• 3-5 years of pertinent experience in regulatory writing.

• Required experience in the biopharmaceutical, device, or contract research organization industry.

• Strong knowledge of EMA, FDA, and ICH regulations, as well as other regulatory guidelines and/or good publication practices is essential.

• Proven experience in writing relevant document types is required.

• In-depth understanding of English grammar and clear communication skills.

• Strong familiarity with the AMA Manual of Style.

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

• Equivalent experience, skills, and/or education will also be taken into account.

🏝️ Benefits

• Opportunities for career development and advancement.

• Supportive and engaged line management.

• Technical and therapeutic area training.

• Recognition from peers.

• Comprehensive total rewards program.

• An inclusive culture.

• Reasonable accommodations, when appropriate, under the Americans with Disabilities Act.