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 supervise writing tasks across various departments.

• Facilitate the resolution of client feedback.

• Produce 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.

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

• Organize quality and editorial reviews and manage source documentation.

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

• Assess statistical analysis plans along with table/figure/listing specifications.

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

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

• Identify and troubleshoot issues, escalating as necessary.

• Offer technical support, training, and consultation.

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

• Mentor and guide less experienced medical writers.

• Develop expertise in industry topics and regulatory requirements.

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

• Carry out administrative tasks and other assigned responsibilities.

• Minimal travel may be necessary, with less than 25% expected.

⛳️ 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 lead writer experience with protocols.

• Proven lead writer experience with submissions.

• Proven lead writer experience with Clinical Summary of Safety (CTD) Modules 2.7.3 and 2.7.4.

• Proven lead writer experience with Clinical Study Reports (CSRs).

• Proven lead writer experience with Investigator Brochures (IBs).

• Proven lead writer experience with Patient Narratives.

• Experience with Safety Aggregate Reports is an advantage.

• Proven lead writer experience with Briefing books.

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

• Strong project management capabilities.

• Excellent client relations experience.

• Strong time management skills.

• Experience with processes is a plus.

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

🏝️ Benefits

• Opportunities for career development and advancement.

• Supportive and engaged line management.

• Training in technical and therapeutic areas.

• Peer recognition and total rewards program.

• Company car or car allowance.

• Medical, Dental, and Vision health benefits.

• Company match for 401k.

• Eligibility to participate in the Employee Stock Purchase Plan.

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

• Flexible paid time off (PTO).

• Sick time.