Job description :
Our client is seeking a full-time Medical Writer with a strong scientific background and excellent writing and communication skills to assist in all aspects of document preparation, including research, writing, and document management.
The employee will report directly to the Research and Development team and will also interface with other departments to provide support in generating a range of documents for submission to Health Canada, the FDA, and other regulatory bodies or government agencies.
Some travel will be required for in-person meetings.
Duties and Responsibilities :
Provide assistance in writing and managing documents related to all phases of the drug development process, including components of clinical trial applications and other submissions containing scientific and clinical data.
As part of document preparation, perform background research in pre-clinical and clinical subject areas.
Ensure that documents are prepared according to the requirements set out by the relevant regulatory body / agency.
Coordinate with internal departments to manage document content and ensure that deadlines are met.
Skills and qualifications :
Scientific background in biological, pharmacological or related fields, with an MSc, MD, or PhD degree.
Ability to write scientifically in English.
Ability to interpret and summarize or synthesize non-clinical research in the basic sciences and clinical research.
Knowledge of the drug development process, clinical research, and ICH guidelines would be beneficial.
Previous experience writing Investigator’s Brochures or Common Technical Documents would be an asset.
Ability to interpret and adhere to document guidelines set out by regulatory bodies.
Ability to prioritize, effectively manage time, and meet deadlines.
Attention to detail.
Ability to communicate effectively (at times with multiple internal departments) when preparing documents.