Senior Medical Writer – Early phase

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

📋 Description

• Oversees the precise and accurate completion of medical writing outputs, ensuring that scientific information is communicated clearly and correctly.

• Manages medical writing tasks associated with individual studies, coordinating activities across departments with minimal oversight.

• Directs the resolution of client feedback.

• Produces a range of documents, which may include clinical study protocols and 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 meetings.

• Complies with established regulatory requirements, including but not limited to ICH E3 guidelines, along with company standard operating procedures, client standards, and any approved templates, authorship requirements, and formatting guides, ensuring timely and budget-conscious completion of medical writing projects.

• Coordinates quality assurance and editorial reviews.

• Ensures proper management of source documentation.

• Leads team document reviews and assesses documents as necessary.

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

• Evaluates statistical analysis plans and table/figure/listing specifications for content appropriateness, grammar, formatting, and consistency.

• Offers feedback to clearly define the necessary statistical output and document requirements.

• Engages with and cultivates strong working relationships with clients, department heads, and peers in data management, biostatistics, regulatory affairs, and medical affairs, as needed, to produce writing deliverables.

• Conducts online clinical literature searches while adhering to copyright laws.

• Identifies and suggests solutions to issues, escalating them as needed.

• Provides technical support, training, and consultation to departmental and other company personnel.

• May assist in the development of internal materials and presentations or modifications to internal processes, standard practices, and capabilities.

• Guides and mentors junior medical writers on complex projects, as required.

• Cultivates in-depth expertise on key topics within the industry and the regulatory frameworks that impact medical writing.

• Monitors budget specifications for assigned projects, ensuring work remains within budgeted hours and communicates status and changes to medical writing leadership.

• Completes necessary administrative tasks within designated timeframes.

• Performs additional work-related duties as assigned.

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

⛳️ Requirements

• 3-5 years of pertinent experience in regulatory writing.

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

• Strong comprehension of EMA, FDA, and ICH regulations, as well as other regulatory guidelines and good publication practices is essential.

• Experience in writing relevant document types is mandatory.

• Comprehensive knowledge of English grammar and the ability to communicate effectively is required.

• Strong familiarity with the AMA Manual of Style.

🏝️ Benefits

• We are dedicated to the development of our staff through career growth and advancement opportunities.

• Supportive and engaged line management.

• Technical and therapeutic area training.

• Peer recognition.

• Total rewards program.

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