Principal Medical Writer - Publications

Job description

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%. How Jobgether works: We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team. We appreciate your interest and wish you the best! Why Apply Through Jobgether? Data Privacy Notice: By submitting your application, you acknowledge that Jobgether will process your personal data to evaluate your candidacy and share relevant information with the hiring employer. This processing is based on legitimate interest and pre-contractual measures under applicable data protection laws (including GDPR). You may exercise your rights (access, rectification, erasure, objection) at any time. #LI-CL1 This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Principal Medical Writer - Publications based in Canada. This is a senior medical writing opportunity focused on producing high-quality scientific publications and complex clinical documentation.You’ll lead writing strategies and deliverables across studies, working closely with multidisciplinary clinical and scientific teams.The role combines scientific expertise, publication knowledge, regulatory awareness, and strong editorial judgment.You’ll translate complex clinical and statistical information into clear, accurate, and compelling documents for scientific audiences.As a senior contributor, you’ll advise stakeholders, manage reviews, resolve feedback, and help maintain consistently high-quality deliverables.You’ll also mentor other writers and contribute to evolving processes, capabilities, and best practices within a global life sciences environment.This remote role is ideal for an experienced medical writer who enjoys ownership, collaboration, and work that ultimately supports advances in patient care.