Medical Writer II

2 weeks ago

Guelph, Ontario, Canada Nutrasource Full time $80,000 - $120,000 per year

Company Overview

Nutrasource is a global CRO and consulting firm that has evolved from a small office to a leader in regulatory affairs and clinical trials since its establishment in 2002. With a focus on customer needs, we provide comprehensive testing solutions for health products to enhance wellness.

We are seeking a Mid- to Senior-Level Medical Writer who can work for us on a full-time basis in Guelph, Ontario (hybrid role) within the Scientific Affairs team.

The Medical Writer II plays a key role within the Scientific Affairs team, contributing to the preparation of high-quality clinical and regulatory documentation to support the design, conduct, and reporting of clinical trials. This individual will be responsible for authoring and reviewing a range of scientific documents, ensuring clarity, scientific accuracy, and compliance with applicable guidelines and regulations.

This position requires active contribution to the mentorship and training of junior writing staff, helping to foster excellence and consistency across the team's deliverables.

Primary Responsibilities:

· Author and review clinical and regulatory documents, including but not limited to:

  • Clinical Study Protocols

  • Investigator's Brochures (IBs)

  • Clinical Study Reports (CSRs)

  • Informed Consent Forms (ICFs)

  • Responses to regulatory authorities and other scientific communications.

· Interpret and synthesize clinical data into clear, scientifically robust documents aligned with internal and external standards (ICH, GCP, Health Canada, FDA).

· Ensure consistency and accuracy across all documents, maintaining alignment with clinical study designs, objectives, and data outputs.

· Work closely with cross-functional teams including Clinical Operations, Biostatistics, and Project Management to ensure timely and accurate delivery of documents.

· Participate in discussions related to study design and clinical endpoints, providing scientific writing input and contributing to project strategy.

· Critically analyze complex information and collaborate with clinical and statistical teams on data description, presentation and analysis

· Engage with internal stakeholders and, as needed, external clients or investigators to clarify content and ensure scientific alignment.

· Provide mentorship, guidance, and training to junior writing staff to support their professional growth and ensure adherence to internal standards.

· Contribute to the continuous improvement of internal writing processes, templates, and standard operating procedures.

· Support quality review and internal peer-review processes, offering constructive feedback to maintain scientific rigor and editorial excellence.

· Adhere to company quality systems and applicable regulatory guidelines (Health Canada/FDA/ ICH guidelines, and principles of GXP/ICH/CTD and other global standards).

· Maintain up-to-date knowledge of relevant regulatory and industry standards in medical and regulatory writing.

Core Competencies:

· Excellent scientific writing and editing skills with a strong ability to interpret and present complex data clearly and accurately.

· Deep understanding of clinical trial design, conduct, and reporting, including regulatory requirements for clinical documentation.

· Strong attention to detail and commitment to delivering high-quality work within established timelines.

· Effective interpersonal skills and the ability to collaborate productively across disciplines and organizational levels.

· Demonstrated ability to mentor and support junior colleagues in developing strong scientific writing skills.

· Strong organizational and time management skills, with the ability to manage multiple priorities simultaneously.

Qualifications:

· Education: Bachelor's, Master's, or PhD in a scientific, medical, or health-related discipline.

· Experience: Minimum 3–7 years of experience in medical or regulatory writing within a Contract Research Organization (CRO), pharmaceutical, biotechnology, or nutraceutical environment.

· Proven experience in authoring clinical and regulatory documents.

· Solid understanding of ICH-GCP, Health Canada, and FDA guidelines.

· Exceptional command of written English and demonstrated ability to write clear, accurate, and scientifically sound documents.

· Proficiency with Microsoft Office Suite; familiarity with reference management and data presentation tools (e.g., EndNote, Zotero, Excel, PowerPoint) is an asset.

Job Type: Full-time

Benefits:

  • Dental care
  • Extended health care
  • Life insurance
  • On-site parking
  • Paid time off

Work Location: In person

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