Job Description

Accountabilities:

The Associate Director, Medical Writing will oversee the creation and execution of critical clinical and regulatory documentation while supporting the evolution of medical writing capabilities. This role requires strong collaboration, attention to detail, and the ability to manage multiple priorities in a dynamic development environment.

• Serve as a primary author for complex clinical, nonclinical, and safety documents, including protocols, Investigator’s Brochures, Clinical Study Reports, informed consent forms, regulatory modules, briefing documents, and other submission materials.
• Partner with subject matter experts and document owners to develop accurate, well-structured, scientifically sound content aligned with regulatory expectations.
• Ensure medical writing activities remain inspection-ready through strong documentation practices, quality oversight, and compliance with applicable guidelines.
• Develop and maintain standardized writing processes, templates, terminology resources, and style guidelines to improve consistency and efficiency across programs.
• Manage and support medical writers, contractors, and external vendors contributing to regulatory documentation activities.
• Collaborate with cross-functional teams including clinical operations, biostatistics, regulatory affairs, and medical leadership to ensure project timelines and deliverables are achieved.
• Support strategic objectives by contributing to the development and improvement of medical writing processes, goals, and operational practices.
• Manage multiple projects and deliverables simultaneously while maintaining high standards of quality, accuracy, and compliance.

Requirements:

The ideal candidate brings strong medical writing expertise, scientific knowledge, and experience supporting clinical development programs within pharmaceutical, biotechnology, or related environments.

• Bachelor’s degree in a scientific, clinical, or related discipline required; advanced scientific degree such as a PhD preferred.
• Minimum of 5 years of sponsor-level pharmaceutical or biotechnology clinical/regulatory medical writing experience; CRO experience considered.
• Fluent or native-level American English proficiency with excellent written and verbal communication skills.
• Demonstrated experience writing eCTD Module 5 and Module 2 content for global regulatory submissions.
• Strong understanding of clinical development processes, including protocol development, clinical trials, regulatory submissions, and drug development methodologies.
• Knowledge of regulatory guidance relevant to medical writing activities and ability to ensure document compliance.
• Experience reviewing and proofreading documents for accuracy, consistency, and alignment with internal and external standards.
• Ability to analyze complex scientific data, summarize findings, and communicate conclusions effectively.
• Strong organizational skills with the ability to prioritize and manage multiple projects in a fast-paced environment.
• Ability to work independently while collaborating effectively with cross-functional teams.
• Proficiency with Microsoft Office tools; familiarity with Veeva Vault, Please Review, and pharmacovigilance documentation is preferred.
• Solution-oriented mindset with strong attention to detail and commitment to quality.

Benefits:

• Competitive annual salary range of $142,500 – $192,500 CAD.
• Remote work flexibility with preference for candidates located on the East Coast.
• Opportunity to contribute to innovative therapies addressing significant patient needs.
• Collaborative environment with scientific, clinical, and regulatory experts.
• Inclusive workplace culture that values diversity, equity, and belonging.
• Opportunities to influence processes, build infrastructure, and support organizational growth.
• Professional development opportunities within a growing biotechnology organization.