Senior Medical & Regulatory Writer – Clinical Research

For over 25 years, dicentra has been a trusted global leader in regulatory consulting and clinical research for the life sciences and dietary supplement industries. We partner with innovators worldwide to navigate complex regulatory landscapes, turn scientific rigor into commercial success, and bring safe, compliant products to market.

We have an immediate opening for an experienced Senior Medical & Regulatory Writer to support the development of clinical and regulatory documentation across our clinical research portfolio. We welcome applications from professionals interested in full-time or part-time employment, as well as independent consultants available for project-based or ad-hoc assignments.

The Opportunity

In this role, you will lead the development of high-quality clinical and regulatory documents supporting studies across pharmaceuticals, medical devices, and natural health products (NHPs) / dietary supplements.

You will work collaboratively with clinical operations, biostatistics, regulatory specialists, and external partners to develop clear, scientifically accurate, and regulatory-compliant documentation.

This opportunity is ideal for an experienced medical writer who can independently manage complex writing assignments, translate scientific and clinical data into compelling technical documents, and contribute to successful clinical trial execution and regulatory submissions.

The scope and level of involvement will be determined based on project requirements and the agreed engagement arrangement, offering opportunities for both ongoing collaboration and individual project assignments.

Key Responsibilities

• Clinical Protocol Development:
  Lead the authoring, review, and revision of clinical study protocols, protocol amendments, and supporting documentation.
• Informed Consent & Investigator Documentation:
  Develop informed consent forms (ICFs), Investigator’s Brochures (IBs), and other essential clinical trial documents.
• Clinical Study Reports (CSRs):
  Author comprehensive CSRs, integrating clinical findings, statistical analyses, safety data, and scientific interpretation.
• Regulatory Documentation:
  Prepare and review clinical and scientific documentation supporting regulatory submissions to Health Canada, the U.S. FDA, and other applicable regulatory authorities.
• Cross-Functional Collaboration:
  
  Work closely with clinical operations, biostatistics, data management, and regulatory teams to ensure scientific accuracy, consistency, and completeness of deliverables.
• Document Quality & Compliance:
  Ensure documentation aligns with applicable regulatory guidance, ICH-GCP principles, company SOPs, and sponsor requirements.
• Scientific Literature Review:
  Conduct literature reviews and synthesize relevant scientific evidence to support study design, clinical documentation, and regulatory submissions.
• Project & Timeline Management:
  Independently manage writing assignments, coordinate review cycles, and deliver high-quality documentation within agreed timelines.

Qualifications & Background

• Education:
  
  Bachelor’s degree in Life Sciences, Health Sciences, Pharmacy, or a related scientific discipline; an advanced degree (Master’s, Pharm.D., or Ph.D.) is preferred.
• Experience:
  
  5+ years of medical or regulatory writing experience, with demonstrated authorship of clinical study protocols, informed consent forms, Investigator’s Brochures, and/or Clinical Study Reports.
• Clinical Research Knowledge:
  Strong understanding of clinical trial design, clinical research methodologies, and the interpretation of clinical and statistical data.
• Regulatory Acumen:
  Working knowledge of ICH-GCP guidelines, ICH E3 and relevant clinical documentation standards, and Health Canada /…