Manager, Medical and Scientific Writing in Canada Creek, Nova Scotia at Jobgether

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Manager, Medical and Scientific Writing based in Canada.

This leadership role oversees medical and scientific writing activities supporting clinical research and regulatory submissions across the pharmaceutical, biotechnology, and medical device sectors. You will combine hands-on medical writing expertise with people leadership, project oversight, and quality management. The role involves authoring and reviewing complex clinical and regulatory documents across multiple stages of clinical development. You will help establish standards, improve processes, monitor performance, and ensure consistently high-quality deliverables. You will also work directly with clients and cross-functional teams while contributing to business development and service improvements. This is an opportunity to shape a growing medical writing function while supporting important clinical development programs.

You will provide functional leadership for day-to-day medical and scientific writing operations, balancing hands-on technical delivery with team development, project management, quality oversight, and continuous improvement.

• Lead the planning, execution, tracking, and delivery of assigned medical and scientific writing projects.
• Ensure project objectives, timelines, policies, procedures, and quality standards are consistently met.
• Mentor project team members and monitor compliance with established standards and practices.
• Perform peer reviews of clinical and scientific documents, applying relevant therapeutic expertise and scientific knowledge.
• Author accurate, concise documents supporting regulatory submissions and clinical trial activities, including briefing packages, IND/NDA/BLA summaries and overviews, ISS and ISE documents, clinical study protocols, CSRs, DSURs, Investigator’s Brochures, patient narratives, manuscripts, posters, and abstracts.
• Ensure appropriate quality control checks are completed for medical writing deliverables.
• Recruit, train, motivate, and develop medical writing staff while supporting strong professional and technical performance.
• Conduct annual and semi-annual performance reviews and oversee staff training and development activities.
• Establish and achieve annual departmental goals and objectives.
• Monitor performance metrics and KPIs and analyze results to improve medical and scientific writing activities.
• Contribute to the development and maintenance of policies, SOPs, working instructions, guidelines, and best practices for medical writing and document publishing.
• Investigate and implement new reporting systems, tools, and processes that improve the effectiveness and efficiency of medical writing services.
• Build strong client relationships while maintaining a focus on quality, responsiveness, and successful project delivery.
• Support new business development activities, including cost estimates and responses to Requests for Proposals.
• Conduct business analysis and benchmarking to identify opportunities for continuous improvement.
• Represent departmental needs and priorities as part of the management team.
• Maintain professional development and stay current with applicable medical writing regulations, guidance, and industry standards.

Requirements:

The ideal candidate combines extensive medical writing experience with strong leadership, scientific judgment, regulatory knowledge, and the ability to manage multiple projects and stakeholders in a clinical research environment.

• Advanced degree, preferably a Ph.D., in Clinical, Medical, or Life Sciences, or a Master’s degree with substantial relevant experience.
• At least 11 years of medical writing experience within a pharmaceutical clinical trial or scientific research environment.
• At least 2 years of experience managing projects and/or people.
• Proven experience developing clinical research documents, including Clinical Study Reports and regulatory submission documents.
• Experience preparing scientific publications and other clinical or scientific materials.
• Experience across multiple therapeutic areas and Phase I–IV clinical trials is an asset.
• Strong understanding of clinical trials and common clinical trial statistical analysis methods.
• Ability to understand complex medical information and clinical results and communicate them clearly in written and verbal formats.
• Excellent organizational skills with the ability to manage multiple projects, clients, and changing priorities.
• Strong knowledge of GCP and ICH guidelines, including ICH E3 requirements for the structure and content of Clinical Study Reports.
• Excellent interpersonal and teamwork skills, with a detail-oriented, customer-focused, and quality-driven approach.
• Strong leadership, mentoring, project management, and stakeholder management capabilities.
• Proficiency with Microsoft Office and Adobe Acrobat.
• Experience with the TRS Toolbox pharma edition plugin is an asset.
• Strong commitment to continuous learning and professional development.

Benefits:

• Estimated salary range of $130,000–$150,000 CAD.
• Performance-based bonus opportunity.
• Medical, dental, and vision coverage.
• Life and AD&D insurance.
• Short-term and long-term disability coverage.
• Tuition reimbursement.
• Fitness reimbursement.
• Employee Assistance Program (EAP).
• Pension plan.
• Generous paid time off and sick leave.
• Remote work from a home-based office anywhere in Canada, in accordance with the applicable work-from-home policy.
• Opportunity to lead and develop a medical and scientific writing function supporting clinical research programs.
• Exposure to regulatory submissions, clinical trials, scientific publications, and multiple therapeutic areas.
• Opportunities to contribute to process improvement, business development, and service innovation.
• Inclusive environment with accommodations available throughout the recruitment and selection process for candidates with disabilities.