Principal Medical Writer - Publications

Accountabilities:

• • Lead the development and delivery of complex medical writing and publication deliverables, ensuring scientific information is accurate, clear, consistent, and aligned with project objectives.
  • Define document strategies and coordinate medical writing activities across individual studies and multidisciplinary teams with minimal supervision.
  • Develop and review publication materials, including journal manuscripts, abstracts, posters, presentations, clinical study protocols, clinical study reports, patient narratives, investigator brochures, plain-language summaries, and other scientific documents.
  • Apply relevant regulatory standards, publication practices, client requirements, templates, authorship principles, and style guidelines while delivering projects on time and within budget.
  • Advise clients and study teams on data presentation, document development, and production strategies to achieve quality and stakeholder expectations.
  • Lead document reviews and coordinate technical, editorial, and quality review processes, ensuring source documentation is appropriately managed.
  • Serve as an expert peer reviewer, providing detailed feedback that improves clarity, accuracy, relevance, consistency, and overall document quality.
  • Review statistical analysis plans and table, figure, and listing specifications, providing input on statistical outputs and documentation requirements.
  • Build effective relationships with clients and cross-functional stakeholders across data management, biostatistics, regulatory affairs, medical affairs, and other relevant functions.
  • Conduct clinical literature searches and ensure appropriate adherence to copyright requirements.
  • Identify issues, recommend practical solutions, escalate risks when appropriate, and contribute subject-matter expertise to internal materials, presentations, processes, and standards.
  • Mentor and support less experienced medical writers working on complex documents.
  • Develop and maintain expertise in relevant therapeutic areas, industry developments, regulatory requirements, and medical writing guidelines, while contributing to external industry initiatives where appropriate.
  • Monitor project budgets, communicate status and timeline changes, contribute to bid projections, and negotiate deliverables and deadlines with relevant stakeholders.
  • Represent the medical writing function on clinical study teams, during meetings, conferences, and client presentations.
  • Complete required administrative activities accurately and within established timelines, along with other assigned responsibilities.
  • Travel occasionally as required, expected to be less than 25%.

  Requirements:

  • At least 6 years of relevant experience in medical, scientific, or technical writing.
  • Extensive experience within the biopharmaceutical, medical device, or contract research organization (CRO) environment.
  • Advanced understanding of applicable FDA and ICH regulations and guidelines and/or good publication practices.
  • Extensive experience developing and reviewing relevant medical writing and scientific publication document types.
  • Strong scientific and medical writing expertise, with excellent command of English grammar, structure, and technical communication.
  • Strong familiarity with the AMA Manual of Style and the standards expected for high-quality scientific publications.
  • Ability to interpret complex clinical and statistical information and communicate it clearly to technical and non-technical audiences.
  • Strong project coordination, prioritization, problem-solving, and organizational skills, with the ability to manage multiple deliverables and competing deadlines.
  • Demonstrated ability to work independently while collaborating effectively with cross-functional and client-facing teams.
  • Strong leadership and mentoring capabilities, with the ability to provide constructive technical and editorial feedback.
  • Sound judgment and a proactive approach to identifying risks, resolving issues, and improving processes.
  • Excellent interpersonal and communication skills, with the confidence to advise senior stakeholders and represent medical writing expertise.
  • Ability to work effectively in a fast-changing, highly collaborative global environment.

  Benefits:

  • Fully remote position in Canada.
  • Full-time employment within a global life sciences and healthcare environment.
  • Opportunities for professional development, career progression, and advancement.
  • Supportive and engaged management focused on employee growth.
  • Access to technical and therapeutic-area training.
  • Peer recognition and total rewards programs.
  • Opportunities to collaborate with multidisciplinary experts across clinical, scientific, and regulatory functions.
  • Exposure to diverse projects, therapeutic areas, emerging technologies, and global healthcare initiatives.
  • Opportunity to contribute to work that supports the development and delivery of important therapies to patients.
  • Inclusive environment designed to encourage diverse perspectives, collaboration, and authentic participation.
  • Minimal travel, expected to be less than 25%.