Medical Writer Jobs in Toronto Canada

Principal Medical Writer

Job Details

Job Description

For more than 25 years, Veristat has built a reputation as a thoughtful partner in the clinical development and regulatory submission process. We have done so by hiring talented people who align with our core values and share a common passion for our mission-driven work.

Do you value a collaborative work environment and the opportunity to truly make a difference? If so, you will feel right at home here. At Veristat, you can grow both personally and professionally, with opportunities to discuss your achievements and advance your career through quarterly feedback conversations and meaningful work. We do things differently than large CROs and would love to have you join our Veristat team!

The Principal Medical Writer independently plans and prepares a variety of clinical documents necessary for all phases of clinical drug and device development by organizing, analyzing, and interpreting scientific and statistical data.  Such documents include Module 2 clinical summaries of marketing applications, integrated summaries of safety and efficacy, clinical study reports, study protocols, investigator’s brochures, aggregate safety reports, and manuscripts.

As a Principal Medical Writer, You Will…

• Conduct overall planning and writing of the clinical sections of global marketing applications and other regulatory documents.
• Develop timelines and resource plans for the clinical sections of submission or for implementation of communication strategy.
• Review statistical analysis plans as required.
• Perform “peer” reviews of documents written by other medical writers as required.
• Mentor junior members of the Medical Writing department.
• Keep management informed on the progress of documents and other project-related information.
• Assist management in projecting resources and performing administrative duties as requested.
• Work independently with the sponsor representative(s) with regard to document planning, review, revision, and finalization.

Experience + Requirements

• Bachelor’s Degree in a science or related field.
• Minimum of 8 to 10 years of medical writing experience in a CRO, pharmaceutical, or biotechnology setting. Other professional and/or educational experience may contribute toward this minimum requirement, as determined on a case-by-case basis.
• Working knowledge of ICH and other regulatory guidelines is required. The ability to accurately and clearly present clinical data; strong verbal, written, and interpersonal communication skills; and proficiency in Microsoft Word is required.
• Broad knowledge of global pharmaceutical regulatory requirements is required, and experience in clinical research or other areas of the pharmaceutical industry is preferred.
• Excellent regulatory writing skills (e.g., English usage) and keen attention to detail also are required.