Principal Medical Writer
1 day ago
Senior Medical Writer (Canada) Job Description
We are seeking a Senior Medical Writer to work as an embedded writer with a client in the Immunology therapeutic space. This is a remote role working from Canada on the EST timezone.
The successful candidate will provide high-quality medical and scientific writing from planning and coordination through delivery of final drafts to internal and external clients. They will collaborate with internal and external clients, supporting and enabling effective and efficient communication that results in operational excellence.
Key Responsibilities:
- Serves as primary author for an FSP client who writes and provides input on routine documents such as clinical study reports and study protocols and summarizes data from clinical studies.
- May research, write or edit complex clinical and scientific and program level documents, including IBs, INDs, and MAAs.
- Reviews routine documents prepared by junior team members. May provide training and mentorship for junior writers and program managers on document preparation, the use of software for document development, document types, regulatory requirements, and therapeutic area knowledge.
- Ensures compliance with quality processes and requirements for assigned documents. Provides input on and independently develops best practices, methods, and techniques for achieving optimal results, including various client specific processes.
- May assist in program management activities. Identifies and resolves out of scope activities. Duties could include developing timelines, budgets, forecasts, and contract modifications.
- Represents the department at project launch meetings, review meetings, and project team meetings.
Requirements:
- Bachelor's degree in a scientific discipline or equivalent and relevant formal academic / vocational qualification; Advanced degree preferred.
- Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years of regulatory writing).
- Experience working in the pharmaceutical/CRO industry preferred.
- Experience working within FSPs preferable.
- Additional qualifications in medical writing (AMWA; EMWA; RAC) advantageous.
Desirable Skills and Qualities:
- Excellent data interpretation and medical writing skills, including grammatical, editorial, and proofreading skills
- Strong project management skills
- Excellent interpersonal skills including problem solving.
- Strong negotiation skills
- Excellent oral and written communication skills with strong presentation skills
- Significant knowledge of global, regional, national, and other document development guidelines
- In-depth knowledge in a specialty area such as preclinical, therapeutic, regulatory submissions, communications, etc.
- Great judgment and decision-making skills
- Excellent computer skills and skilled with client templates; Good knowledge of document management systems and other relevant applications (e.g., Excel, Outlook).
About Thermo Fisher Scientific:
Thermo Fisher Scientific is a global organization that enables our customers to make the world healthier, cleaner, and safer. We share a common set of values - Integrity, Intensity, Innovation, and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation, and support patients in need.
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