Medical Writer
Nutrasource
Guelph, ON

Position Overview:

Our rapidly expanding team is seeking a Medical Writer who can work for us on a full-time basis, supporting our clinical operations team located in Guelph. Reporting to The Senior Director of Scientific Affairs, the Medical Writer is responsible for developing high-quality, scientifically valid clinical documents for pipeline and/or marketed products according to internal document standards and within project timelines.

Primary Responsibilities:

Represents medical writing on project teams and actively participates in interactions including provision of scientific background information as needed

Writing high-quality, scientifically/medically accurate documents including study protocols, study reports and Investigator Brochures

Acting as a subject matter authority on the supported therapeutic areas

Procuring, organizing, and handling reference materials from various sources including peer-reviewed scientific journals, government and medical society publications, and reputable websites

Collaborating autonomously with internal colleagues and, when appropriate, external clients.

Handling and prioritizing multiple parallel work streams to meet established achievements

Provides quality control review of various regulatory and medical communications documents

Evaluating and identifying supporting documentation, organizing and annotating references

Core Competencies:

Demonstrated ability to produce clear, concise, and effective written and verbal communications describing scientific and clinical data in English

Understanding of clinical product development, clinical research, clinical study design, biostatistics, medical terminology, the regulatory environment including FDA/ICH guidelines, and principles of GXP/ICH/CTD and other global standards

Ability to work collaboratively and coordinate the efforts of team members to resolve comments, and produce a final high-quality document

Well-organized with demonstrated ability to prioritize tasks, work simultaneously on multiple projects, and complete high-quality documents according to timelines

Expertise in gathering, evaluating, and summarizing scientific literature

Ability to find and correct errors in spelling, punctuation, grammar, consistency, clarity, and accuracy

Fluent in word processing, flow diagrams and spreadsheets

Ability to critically review own work before sending out for internal/external review by team

Ability to work in a fast-paced, cohesive, collaborative team-oriented work environment

Qualifications:

Bachelor’s degree in a scientific or health-related field required; PharmD, PhD preferred

At least one (1) year of medical writing experience as a Medical Writer in the health care industry; medical/regulatory/publication writing in the pharmaceutical/nutraceutical/biotech/device, medical communications, or CRO industries

Job Type: Full-time

Experience:

  • medical writing: 1 year (Required)