Senior Medical Writer – Regulatory Focus

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

📋 Description

• Oversee the precise and effective execution of medical writing deliverables.

• Manage medical writing tasks for specific studies and facilitate coordination across various departments.

• Take the lead in addressing and resolving client feedback.

• Draft clinical study protocols and 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, standard operating procedures, client-specific standards, approved templates, authorship requirements, and style and formatting guidelines.

• Organize quality and editorial reviews, as well as manage source documentation.

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

• Evaluate 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 clinical literature searches while ensuring compliance with copyright laws.

• Identify and address issues, escalating them as necessary.

• Provide technical support, training, and consultations.

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

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

• Cultivate expertise in industry topics and regulatory requirements.

• Monitor project budgets, hours, status updates, and changes.

• Complete administrative duties and other assigned responsibilities.

⛳️ Requirements

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

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

• Proven experience as a lead writer for protocols, submissions, CTD Modules 2.7.3 and 2.7.4, Clinical Study Reports, Investigator Brochures, Patient Narratives, Briefing Books, ISE, and ISS.

• Experience with Safety Aggregate Reports is advantageous.

• Excellent project management skills.

• Strong client-facing experience.

• Exceptional time management skills.

• Process experience is a plus.

• Must be willing to work remotely from the US, UK, or Canada.

• Equivalent experience, skills, and/or education may be considered.

🏝️ 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.

• An inclusive company culture.

• Minimal travel required (less than 25%).