Sponsor Dedicated Protocol Medical Writer II

This is a fully remote position, open to applicants in Canada, +3 more countries.

📋 Description

• Collaborate closely with Clinical Scientists on study protocols and amendments.

• Deliver precise and effective medical writing outputs.

• Oversee medical writing tasks for individual studies with limited supervision.

• Organize medical writing efforts both within and across various departments.

• Facilitate the resolution of client feedback.

• Prepare clinical study protocols, amendments, reports, patient narratives, annual reports, investigator brochures, informed consent documents, plain language summaries, periodic safety update reports, clinical development plans, IND submissions, integrated summary reports, NDA and eCTD submissions, journal manuscripts, abstracts, posters, and presentations.

• Comply with ICH E3 guidelines, company SOPs, client specifications, approved templates, authorship criteria, and style and formatting manuals.

• Oversee quality and editorial reviews, as well as manage source documentation.

• Lead team document assessments and serve as an internal peer reviewer.

• Evaluate statistical analysis plans and specifications for tables, figures, and listings.

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

• Conduct online searches of clinical literature and adhere to copyright regulations.

• Identify issues and suggest solutions, escalating concerns as necessary.

• Offer technical support, training, and consultation.

• Mentor and guide junior medical writers on complex projects.

• Cultivate expertise in industry topics and regulatory standards.

• Track assigned project budgets and communicate updates and adjustments.

• Fulfill necessary administrative responsibilities and other designated tasks.

⛳️ Requirements

• 3-5 years of relevant experience in medical writing, with a demonstrated background in protocol writing.

• Required experience in the biopharmaceutical, device, or contract research organization sectors.

• Experience in late-stage development is essential.

• Background in Oncology/Hematology/Cell therapy is preferred.

• Strong knowledge of FDA and ICH regulations, along with other regulatory guidelines and good publication practices, is crucial.

• Proven experience in writing relevant document types is necessary.

• Familiarity with Veeva/CARA is advantageous.

• Extensive knowledge of English grammar and the ability to communicate effectively is essential.

• Strong familiarity with the AMA Manual of Style is required.

• Equivalent experience, skills, and/or education will also be considered.

• Minimal travel may be necessary (less than 25%).

🏝️ Benefits

• Opportunities for career development and advancement.

• Supportive and engaged management.

• Training in technical skills and therapeutic areas.

• Peer recognition and a comprehensive rewards program.

• A culture centered on total self.

• A workplace focused on diversity, inclusion, and belonging.