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Posted: 07-Sep-23
Location: Mississauga, Ontario, Canada
Type: Full Time
Categories:
Required Education:
Internal Number: Medical Writer
Intrinsik is a North American consulting firm focusing on the toxicology and regulatory challenges associated with the development of new products (pharmaceuticals, biologics, medical devices, consumer products, natural health products and cosmetics). We are continuing to grow, and will always welcome candidates with strong scientific skills, creativity and enthusiasm to join our team.
Intrinsik has an immediate opening for a Lead Medical/Clinical Writer. This is a hybrid position for any of the following locations:
- Mississauga, Ontario, Canada
- Montreal, Quebec, Canada
- Raleigh, North Carolina, USA
The medical writer will create clinical documentation according to client and company guidelines and international government regulations/guidelines and presents clinical data objectively in a clear/concise format. The lead medical writer provides scientific knowledge, analytical skills, and contributes to cross-functional working groups as needed to facilitate the preparation of reports, and the production of various regulatory dossiers.
We aim to offer our employees an environment that encourages professionalism, creativity, independence, and continual learning. The assets of any knowledge-based company are its people, and we believe strongly in investing in those assets by offering training and mentoring of our staff. Like all modern successful organizations, we are committed to growing and advancing our employees' careers by providing them with new responsibilities and opportunities within the company.
Responsibilities include:
- Authoring or reviewing clinical study protocols and clinical study reports (Phase 2/3 studies), and other regulatory submission documents (e.g., CTD Modules 2.5 and 2.7, and Integrated Safety/Efficacy Summaries, Investigator’s Brochures, and briefing documents for regulatory meetings).
- Analyzing and interpreting scientific/clinical data.
- Executing comprehensive and systematic scientific literature searches, preparing and reviewing tabulated and written summaries of publications.
- Manage medical writing activities including acting as the primary client contact, set and meet internal and external deliverable timelines, and manage contract and budget aspects of projects.
The successful applicant(s) would ideally have the following qualifications and attributes:
- Advanced degree (M.Sc. or Ph.D.) in a life science or related field of study.
- Excellent interpersonal, verbal, and written communication skills.
- Understanding of the drug development process and applicable industry guidelines and regulations (e.g., ICH).
- Minimum of 3 years of medical writing experience, preferably in the pharmaceutical industry.
- Demonstrated high degree of independence and proficiency with scientific writing and attention to detail.
- Ability to multi-task (multiple projects/issues) and prioritize workload within a deadline-oriented, fast-paced environment.
- Ability to effectively work with clients by understanding and meeting their needs and build long-lasting client relationships.
- Ability to work both autonomously and collaboratively with a team.
- Extensive knowledge of English grammar with proven written and spoken English.
