Senior Medical Writer – Regulatory Submission Documents

This is a fully remote position, open to applicants in United States, +1 more country.

📋 Description

• Collaborate closely with Clinical Scientists, concentrating on protocols and protocol amendments.

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

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

• Coordinate medical writing efforts within and across various departments.

• Lead 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 for scientific meetings.

• Comply with ICH E3 guidelines, regulatory standards, SOPs, client specifications, approved templates, authorship requirements, and style and formatting guidelines.

• Organize quality and editorial reviews.

• Appropriately manage source documentation.

• Lead team document reviews and assess documents as necessary.

• Serve as a peer reviewer for scientific content, ensuring clarity, consistency, and adherence to format.

• Review statistical analysis plans along with table, figure, and listing specifications.

• Offer feedback to define statistical outputs and document requirements.

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

• Conduct online clinical literature searches while adhering to copyright regulations.

• Identify issues and propose solutions, escalating as necessary.

• Provide technical support, training, and consultation.

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

• Mentor and lead less experienced medical writers on complex projects.

• Cultivate expertise in industry topics and regulatory requirements that impact medical writing.

• Monitor project budgets and communicate any status updates or changes to medical writing leadership.

• Complete necessary administrative duties.

• Perform other assigned work-related responsibilities.

⛳️ Requirements

• 3-5 years of relevant experience in medical writing.

• Demonstrated experience in writing protocols.

• Experience in the biopharmaceutical, device, or contract research organization sector.

• Familiarity with late-stage development.

• Background in Oncology/Hematology/Cell therapy.

• Strong knowledge of FDA and ICH regulations, other regulatory guidelines, and good publication practices.

• Experience with relevant document types.

• Proficiency in using Veeva/CARA.

• Extensive understanding of English grammar.

• Effective communication skills.

• Strong knowledge of the AMA Manual of Style.

• Ability to work within budgeted hours and communicate status updates and changes.

• Minimal travel may be required (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.

• Inclusive work culture.

• Company car or car allowance.

• Medical, dental, and vision health benefits.

• Company matching for 401k.

• Eligibility for the Employee Stock Purchase Plan.

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

• Flexible paid time off (PTO).

• Sick time.

• Remote work arrangements.