- Review, develop, write, and edit various scientific and regulatory documents, including clinical study reports, investigator brochures, CTD modules, and briefing documents for EU & UK authorities.
- Ensure all documents comply with regulatory requirements, industry guidelines, and internal company standards.
- Participate in interpreting and planning data presentation for individual study reports and summary documents for nonclinical and clinical programs.
- Assist in responding to regulatory agency queries and document revisions as required.
- Perform quality control reviews of documents to ensure consistency, grammar, and adherence to templates.
- Ensure that all content meets the highest standards of clarity, accuracy, and scientific integrity.
- Provide scientific expertise in interpreting data and transforming it into clear documents and summaries.
- A degree in life sciences (e.g., Biology, Pharmacology, Medicine, or related fields) is required; an advanced degree (e.g., MSc, PhD, MD) is preferred.
- Extensive experience as a medical writer within a pharmaceutical, biotech, or CRO environment, with experience in authoring clinical and/or regulatory documentation.
- Familiarity with drug development processes, regulatory submission requirements, and guidelines.
- Experience with clinical trial documentation and regulatory submissions.
- Excellent written and verbal communication skills, with strong attention to detail and a commitment to accuracy and quality.
- Ability to interpret complex scientific data and present it in a clear and concise manner.
- Knowledge of clinical research terminology, medical literature, and regulatory guidelines.
- Proficient in Microsoft Office Suite (Word, Excel, PowerPoint).
- Familiarity with medical publishing standards and platforms.
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Senior Regulatory Medical Writer - Greater London - Coronado Research
Description
Join to apply for the Senior Regulatory Medical Writer role at Coronado Research
We are a growing Scientific and Technology led regulatory consultancy.
To support our growth, we are currently seeking a freelance Senior Regulatory & Scientific Writer to join our expanding team. You will be responsible for producing high-quality scientific and regulatory documents that support the development and commercialization of pharmaceutical and biotechnology products across a variety of therapeutic areas.
Key Responsibilities:
Requirements:
Additional Skills:
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Science
Industries
Pharmaceutical Manufacturing and Biotechnology Research
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Medical Writer/Senior Medical Writer
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