Senior Medical Writer – Publications

This is a fully remote position, open to applicants in Canada.

📋 Description

• Oversees the precise and accurate execution of medical writing deliverables, ensuring that scientific information is conveyed clearly and accurately.

• Manages medical writing tasks related to individual studies, facilitating coordination of medical writing efforts both within and across departments with minimal oversight.

• Produces a diverse range of documents, which may include clinical study protocols and their amendments; clinical study reports; patient narratives; annual reports; investigator brochures; informed consent forms; 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 for scientific conferences.

• Organizes quality assurance and editorial assessments.

• Evaluates statistical analysis plans and specifications for tables, figures, and listings to ensure appropriateness of content, grammar, format, and consistency.

⛳️ Requirements

• Oversees the precise and accurate execution of medical writing deliverables, ensuring that scientific information is conveyed clearly and accurately.

• Produces a diverse range of documents, which may include clinical study protocols and their amendments; clinical study reports; patient narratives; annual reports; investigator brochures; informed consent forms; 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 for scientific conferences.

• Complies with established regulatory standards, including, but not limited to, ICH E3 guidelines, as well as company standard operating procedures, client standards, and approved templates, authorship requirements, and style and formatting guides, while ensuring that medical writing projects are completed on time and within budget.

• Organizes quality assurance and editorial assessments.

• Serves as a peer reviewer for the internal team to ensure the scientific content, clarity, overall consistency, and proper formatting of documents.

• Evaluates statistical analysis plans and specifications for tables, figures, and listings to ensure appropriateness of content, grammar, format, and consistency.

🏝️ Benefits

• We are dedicated to fostering the growth of our employees through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition; and a comprehensive rewards program.

• We are committed to cultivating an inclusive culture where you can genuinely be yourself.