Senior Medical Writer – Regulatory Focus

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

📋 Description

• Oversee the precise and timely completion of medical writing deliverables while managing writing tasks for individual studies.

• Facilitate medical writing efforts across various departments and take the lead in addressing client feedback.

• Produce clinical, regulatory, safety, submission, and scientific meeting documents, including protocols, CSRs, IBs, patient narratives, aggregate reports, IND/NDA/eCTD submissions, manuscripts, abstracts, posters, and presentations.

• Adhere to ICH E3 guidelines, company SOPs, client standards, approved templates, authorship criteria, and style guides.

• Oversee quality and editorial reviews, manage source documentation, and guide team document evaluations.

• Serve as a peer reviewer for scientific content, ensuring clarity, consistency, and proper formatting.

• Evaluate statistical analysis plans and specifications for tables, figures, and listings, providing insights on statistical outputs and document requirements.

• Cultivate strong working relationships with clients and teams in data management, biostatistics, regulatory affairs, and medical affairs.

• Conduct clinical literature searches while adhering to copyright regulations.

• Identify and escalate issues and offer technical support, training, and consultation as needed.

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

• Develop in-depth knowledge of industry topics and regulatory requirements that impact medical writing.

• Monitor assigned project budgets, report on status and changes, and complete necessary administrative tasks.

• Undertake additional responsibilities as assigned; occasional travel may be required (less than 25%).

⛳️ Requirements

• A minimum of 5 years of experience in lead regulatory writing.

• Experience as a lead writer for Phase 2 and Phase 3 studies.

• Proven track record as a lead writer for protocols, submissions, CTD Modules 2.7.3 and 2.7.4, CSRs, IBs, patient narratives, briefing books, ISE, and ISS.

• Familiarity with Safety Aggregate Reports is advantageous.

• Excellent project management skills.

• Strong client management experience.

• Exceptional time management capabilities.

• Experience in process management is a plus.

• Equivalent experience, skills, and/or education may be taken into consideration.

🏝️ Benefits

• Opportunities for career development and advancement.

• Supportive and engaged management.

• Training in technical and therapeutic areas.

• Peer recognition and a comprehensive rewards program.

• An inclusive workplace culture.

• Company car or car allowance.

• Medical, dental, and vision health benefits.

• Company-matched 401(k) plan.

• Eligibility to join the Employee Stock Purchase Plan.

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

• Flexible paid time off (PTO).

• Sick leave.

• Reasonable accommodations provided when suitable.