Lead Medical/Clinical Writer – North America
Intrinsik Corp., is a North American consulting firm that provides regulatory strategy and support from the pre- clinical stage through to market, including content authoring, preparation, submission and maintenance of regulatory documents in Canada, the United States, and Europe.
Intrinsik has an immediate opening for a Lead Medical/Clinical Writer at our Mississauga, ON, Canada location who is looking for an opportunity to work in an environment that truly values scientific excellence, creativity, and initiative. 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.
- 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
- 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
The successful applicant(s) would ideally have the following qualifications and attributes:
- Undergraduate (B.Sc.) or advanced degree (M.Sc. or D.) in a life science or related field of study.
- Excellent interpersonal, verbal, and written communication
- 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
- Demonstrated high degree of independence and proficiency with scientific writing and attention to
- Ability to multi-task (multiple projects/issues) and prioritize workload within a deadline-oriented, fast- paced
- Ability to effectively work with clients by understanding and meeting their needs and build long-lasting client
- Ability to work both autonomously and collaboratively with a
- Extensive knowledge of English grammar with proven written and spoken
Please submit a cover letter and resume via e-mail to Heather Wilson at .moc.1632706574kisni1632706574rtni@1632706574nosli1632706574wh1632706574