Sponsor Dedicated Protocol Medical Writer II/Sr

This is a fully remote position, open to applicants in Canada, +1 more country.

📋 Description

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

• Ensure the precise and comprehensive completion of medical writing deliverables.

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

• Facilitate coordination of medical writing efforts across various departments.

• Take the lead in addressing client feedback.

• Compose clinical study protocols and amendments, clinical study 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, as well as journal manuscripts, abstracts, posters, and presentations.

• Adhere to ICH E3 guidelines, company standard operating procedures, client standards, approved templates, authorship requirements, and style guides.

• Organize quality and editorial reviews while managing source documentation.

• Lead document reviews within the team and serve as an internal peer reviewer.

• Evaluate statistical analysis plans and the 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 while ensuring compliance with copyright regulations.

• Identify and address issues, escalating them as necessary.

• Offer technical support, training, and consultation.

• Mentor and guide less experienced medical writers.

• Cultivate expertise in industry-related topics and regulatory standards.

• Track budgeted hours and communicate updates and changes to medical writing leadership.

• Accomplish necessary administrative responsibilities and any additional assigned tasks.

⛳️ Requirements

• 3-5 years of pertinent experience in medical writing, with demonstrated proficiency in protocol writing.

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

• Experience in late-stage development is essential.

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

• Strong knowledge of FDA and ICH regulations, as well as other regulatory guidelines and good publication practices, is a must.

• Proven experience in writing relevant document types is required.

• Familiarity with Veeva/CARA is necessary.

• Comprehensive understanding of English grammar and the ability to communicate effectively.

• Strong knowledge of the AMA Manual of Style.

• Occasional travel may be necessary (under 25%).

🏝️ Benefits

• Opportunities for career development and advancement.

• Supportive and engaged line management.

• Technical and therapeutic area training provided.

• Peer recognition initiatives.

• Comprehensive total rewards program.

• An inclusive and diverse workplace culture.

• Limited travel requirements (less than 25%).