Principal Medical Writer – Publications

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

📋 Description

• Oversee the precise and effective completion of intricate medical writing deliverables.

• Direct medical writing tasks for specific studies, encompassing document strategy and cross-department collaboration.

• Take charge of addressing client feedback.

• Draft clinical study protocols, amendments, clinical study reports, patient narratives, investigator brochures, informed consent documents, plain language summaries, safety reports, clinical development plans, regulatory submissions, journal manuscripts, abstracts, posters, and presentations.

• Ensure adherence to ICH E3 guidelines, regulatory standards, SOPs, client standards, templates, authorship requirements, and style guides.

• Provide guidance to clients and study teams on data presentation and production strategies.

• Lead document reviews and coordinate quality and editorial assessments.

• Act as an expert peer reviewer.

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

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

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

• Identify and address issues, escalating as necessary.

• Serve as a technical subject matter expert and contribute to internal materials, presentations, processes, and capabilities.

• Mentor and guide less experienced medical writers.

• Cultivate expertise in industry topics and regulatory requirements.

• Engage with external industry groups.

• Monitor project budgets and assist with bid projections.

• Communicate project status and negotiate timelines and deliverables with medical writing leadership.

• Represent the medical writing team on clinical study teams, at conferences, meetings, and client presentations.

• Complete administrative tasks and any other assigned responsibilities.

⛳️ Requirements

• A minimum of 6 years of relevant experience in science, technical, or medical writing.

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

• Advanced comprehension of FDA and ICH regulations and guidelines and/or good publication practices.

• Significant experience in writing pertinent document types.

• Comprehensive knowledge of English grammar and a strong ability to communicate clearly.

• Strong familiarity with the AMA Manual of Style.

• Experience with complex medical writing deliverables and relevant clinical/regulatory document types.

• Equivalent experience, skills, and/or education will also be taken into account.

🏝️ Benefits

• Opportunities for career development and advancement.

• Supportive and engaged management.

• Training in technical and therapeutic areas.

• Peer recognition and comprehensive rewards program.

• Inclusive workplace culture.

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

• Opportunities for various career paths and employment progression.

• Minimal travel requirement (less than 25%).