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Principal Medical Writer
2 months ago
Senior Medical Writer (Canada) Job Description
A senior medical writer is needed to provide high-quality medical and scientific writing for a client in the Immunology therapeutic space.
Job Responsibilities:
- Write and provide input on routine documents such as clinical study reports and study protocols.
- Research, write or edit complex clinical and scientific documents, including IBs, INDs, and MAAs.
- Review routine documents prepared by junior team members and provide training and mentorship.
- Ensure compliance with quality processes and requirements for assigned documents.
- Assist in program management activities, including developing timelines, budgets, and forecasts.
- Represent the department at project launch meetings, review meetings, and project team meetings.
Requirements:
- Bachelor's degree in a scientific discipline or equivalent.
- 5+ years of experience in regulatory writing, preferably in the pharmaceutical/CRO industry.
- Experience working within FSPs is preferred.
- Additional qualifications in medical writing are advantageous.
Key Skills:
- Excellent data interpretation and medical writing skills.
- Strong project management skills.
- Excellent interpersonal skills, including problem-solving and negotiation.
- Excellent oral and written communication skills.
- Significant knowledge of global, regional, and national document development guidelines.
- In-depth knowledge in a specialty area such as preclinical, therapeutic, regulatory submissions, communications, etc.
About the Company:
Thermo Fisher Scientific is a global organization that enables our customers to make the world healthier, cleaner, and safer. We value a collaborative environment, with teams of colleagues eager to share expertise and have fun together.
What We Offer:
A competitive salary, an extensive benefits package, a flexible working culture, and a collaborative environment where you can grow professionally and personally.
