Senior Medical Writer – Regulatory Submission Documents

This is a fully remote position, open to applicants in Canada, +1 more country.

📋 Description

• Collaborate closely with Clinical Scientists on protocols and their amendments.

• Ensure the precise and accurate completion of medical writing deliverables.

• Oversee medical writing activities for individual studies with minimal oversight.

• Coordinate medical writing efforts both within and across departments.

• Lead the resolution of client feedback.

• Produce clinical study 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, as well as style and formatting guides.

• Organize quality and editorial reviews while managing source documentation.

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

• Evaluate statistical analysis plans and table/figure/listing specifications.

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

• Conduct online clinical literature searches while complying with copyright regulations.

• Identify and suggest solutions, escalating issues when necessary.

• Offer technical support, training, and consultation.

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

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

• Develop expertise in industry topics and regulatory requirements impacting medical writing.

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

• Complete administrative tasks and other assigned responsibilities.

⛳️ Requirements

• 3-5 years of relevant experience in medical writing, with a strong focus on Protocol writing.

• Background in the biopharmaceutical, device, or contract research organization sectors.

• Experience in late-stage development.

• Familiarity with Oncology/Hematology/Cell therapy.

• Comprehensive understanding of FDA and ICH regulations, along with other regulatory guidelines and good publication practices.

• Proven experience in writing relevant document types.

• Experience with Veeva/CARA.

• In-depth knowledge of English grammar and exceptional communication skills.

• Strong proficiency with the AMA Manual of Style.

• Some travel may be required (less than 25%).

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

🏝️ Benefits

• Opportunities for career development and advancement.

• Supportive and engaged line management.

• Training in technical and therapeutic areas.

• Recognition from peers.

• Comprehensive total rewards program.

• An inclusive workplace culture.

• Minimal travel requirements (less than 25%).