Medical Writer, Clinical Trials (Associate)

Pharma Medica Research Inc.

Mississauga

On-site

CAD 60,000 - 80,000

Full time

46 hours ago
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Benefits offered by this job

Competitive compensation
Fully paid benefit plan
Career progression
Milestones awards program
Corporate discounts
Friendly atmosphere

Job summary

Pharma Medica Research Inc. in Mississauga is seeking an Associate Medical Writer to join our team.

You will prepare safety and efficacy conclusions for CSR sections across Phase I–III studies, review clinical documentation, and collaborate with sponsors and internal teams to ensure high-quality reports. The role requires a background in medical sciences, strong writing skills, and knowledge of ICH/GCP guidelines.

Qualifications

  • 1 year of medical writing experience in a CRO/pharma/biotech setting.
  • Thorough knowledge of ICH and GCP guidelines.
  • Excellent written and oral communication skills.
  • Ability to work independently and in a team.

Responsibilities

  • Write safety and efficacy conclusions for CSR sections from study data.
  • Review clinical documentation to support CSR conclusions.
  • Follow CSR templates, checklists, and PMRI manuals.
  • Prepare sponsor correspondence regarding CSR and address sponsor comments.
  • Review eCRF design and MOCK TLF for consistency with protocols.
  • Check outputs from the Clinical Data Management team for clinical relevance.
  • Develop tools to improve quality and efficiency of report writing.
  • Participate in sponsor teleconferences as needed.
  • Generate study protocols and ICFs for Phase I–III studies when assigned.
  • Collaborate with departments on protocol sections and ensure accuracy.

Skills

Medical writing proficiency
Editorial excellence
Multitasking ability
Communication skills
Team collaboration

Education

BSc in Medical Sciences or Health Science

Job description

Pharma Medica Research Inc. in Mississauga is seeking an Associate Medical Writer to join our team.

You will prepare safety and efficacy conclusions for CSR sections across Phase I–III studies, review clinical documentation, and collaborate with sponsors and internal teams to ensure high-quality reports. The role requires a background in medical sciences, strong writing skills, and knowledge of ICH/GCP guidelines.

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