Senior Medical & Regulatory Writer – Clinical Research

dicentra Inc.; Kanada; Remote; CAD 90.000 - 140.000; Vollzeit

Zusammenfassung

dicentra Inc. is seeking a Senior Medical & Regulatory Writer to develop clinical and regulatory documentation across our portfolio.

The role supports studies across pharmaceuticals, medical devices, and NHPs/dietary supplements, collaborating with clinical operations, biostatistics, and regulatory teams. This position offers flexibility with full-time, part-time, or independent contracting arrangements, and is fully remote within Ontario.

Qualifikationen

• 5+ years of medical or regulatory writing experience.
• Authorship of clinical study protocols, ICFs, IBs, and CSRs desirable.
• Strong understanding of clinical trial design and regulatory standards.

Aufgaben

• Lead authoring, review, and revision of protocols and amendments.
• Develop ICFs, IBs, and other essential clinical trial documents.
• Author CSRs integrating findings, statistics, and safety data.
• Prepare regulatory documentation for Health Canada, FDA, and others.
• Collaborate with跨-functional teams to ensure accuracy and completeness.
• Ensure compliance with ICH-GCP, SOPs, and sponsor requirements.
• Conduct literature reviews to support study design and submissions.
• Manage writing assignments, reviews, and timelines independently.

Kenntnisse

Scientific writing

Editing

Cross-functional communication

Independent project delivery

Critical review

Ausbildung

Bachelor's degree in Life Sciences or related

Master’s/Pharm.D./Ph.D. preferred

Jobbeschreibung

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 / FDA regulatory expectations.
• Scientific Writing Excellence: Exceptional technical writing, editing, and critical review skills, with the ability to translate complex scientific information into clear, accurate, and well-structured documents.
• Cross-Functional Communication: Ability to collaborate effectively with clinical research professionals, statisticians, regulatory specialists, and client sponsors.
• Independent Project Delivery: Demonstrated ability to manage multiple writing assignments, incorporate stakeholder feedback, and deliver high-quality documents with minimal supervision.

Best workplace
We nourish an environment devoted to honesty and fairness, trust and respect. We care deeply for our team members and take work-life balance seriously, allowing our people to decide on a schedule that best fits their life and working preferences.

Best people
We unite cross-industry professionals with a shared passion for improving people’s health and wellness. Our inspiring leaders are accessible and work eagerly side-by-side with individual employees to help them understand and achieve their objectives.

Best opportunities
We encourage our team members to continuously develop and enhance their skills and expertise. We recognize and reward courageous choices and innovative ideas that result in the growth of our people and company, and in the success of our clients.

Become a part of a purpose-driven and future-oriented business that impacts and improves millions of lives worldwide!

Job Type: Full-Time Employment, Part-Time Employment, or Independent Consulting Contract (Project-Based / Ad-Hoc)

Location: Ontario (Fully Remote)