Principal Medical Writer – Regulatory

This is a fully remote position, open to applicants in Canada.

📋 Description

• Oversee the precise and clear execution of medical writing deliverables while coordinating activities across various departments.

• Facilitate the resolution of client feedback.

• Prepare clinical and regulatory documents such as protocols, clinical study reports, patient narratives, investigator brochures, informed consents, plain language summaries, safety reports, clinical development plans, IND submissions, integrated summary reports, NDA and eCTD submissions, manuscripts, abstracts, posters, and presentations.

• 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 effectively.

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

• Assess statistical analysis plans and specifications for tables/figures/listings, offering insights on statistical outputs and documentation needs.

• Foster collaborative relationships with clients and teams in data management, biostatistics, regulatory affairs, and medical affairs.

• Conduct online clinical literature searches while ensuring compliance with copyright regulations.

• Identify issues and propose solutions, escalating matters as necessary.

• Offer technical support, training, and consultation to team members.

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

• Cultivate knowledge in industry-related topics and regulatory requirements impacting medical writing.

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

• Complete mandatory administrative duties and other assigned responsibilities.

⛳️ Requirements

• Experience, skills, and/or education equivalent to the qualifications established by the company may be taken into account.

• Compliance with ICH E3 guidelines, company SOPs, client standards, approved templates, authorship requirements, and style and formatting guidelines is essential.

• Capability to review statistical analysis plans and specifications for tables/figures/listings.

• Proficiency in performing online clinical literature searches while adhering to copyright regulations.

• Ability to operate within budgeted hours and communicate updates or changes regarding project status.

• Competence in providing technical support, training, and consultation.

• Ability to mentor and lead less experienced medical writers on complex projects.

• Skill in developing expertise in regulatory requirements and guidelines that affect medical writing.

• Occasional travel may be necessary (less than 25%).

🏝️ Benefits

• Opportunities for career development and advancement.

• Supportive and engaged management team.

• Training in technical and therapeutic areas.

• Peer recognition and comprehensive rewards program.

• An inclusive workplace culture.

• Access to extensive resources, including emerging technologies, data, science, and knowledge sharing.

• Occasional travel may be necessary (less than 25%).