Senior Medical Writer – Regulatory Focus

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

📋 Description

• Oversee the creation of precise medical writing deliverables and facilitate activities within and between departments.

• Lead the resolution process of client feedback.

• Draft protocols, 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.

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

• Coordinate quality and editorial reviews while managing source documentation.

• Lead document reviews within the team and evaluate documents as necessary.

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

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

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

• Conduct online searches of clinical literature and ensure compliance with copyright regulations.

• Identify and address issues, escalating them as needed.

• Offer technical support, training, and consultation.

• Contribute to the development of internal materials, presentations, processes, standard practices, and overall capabilities.

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

• Cultivate expertise in industry-related topics and regulatory guidelines.

• Operate within budgeted hours and communicate status updates and modifications to medical writing leadership.

• Complete necessary administrative tasks.

• Carry out other assigned responsibilities.

• Travel may be required, limited to less than 25%.

⛳️ Requirements

• At least 5 years of experience in lead regulatory writing.

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

• Proven background in writing protocols.

• Demonstrated lead writer experience with submissions.

• Familiarity with CTD Modules 2.7.3 and 2.7.4 as a lead writer.

• Experience as a lead writer for Clinical Study Reports (CSRs).

• Background as a lead writer for Investigator Brochures (IBs).

• Experience in writing Patient Narratives.

• Knowledge of Safety Aggregate Reports is advantageous.

• Experience as a lead writer for Briefing Books.

• Lead writer experience with Integrated Summary Efficacy (ISE) and Integrated Summary Safety (ISS).

• Excellent project management capabilities.

• Strong client relationship skills.

• Effective time management abilities.

• Experience with process management is a plus.

• Open to candidates located in the US, UK, and Canada.

🏝️ Benefits

• Opportunities for career development and advancement.

• Supportive and involved line management.

• Training in both technical skills and therapeutic areas.

• Peer recognition and a comprehensive rewards program.

• An inclusive corporate culture.

• Company vehicle or vehicle allowance.

• Health benefits including Medical, Dental, and Vision coverage.

• Company-matched 401k plan.

• Eligibility to participate in the Employee Stock Purchase Plan.

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

• Flexible paid time off (PTO).

• Sick leave provisions.