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:

• The ability to Review, develop, write, and edit various scientific and regulatory documents, including clinical study reports, investigator brochures, CTD modules, briefing documents for US, 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.

Requirements:

• 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.
• Minimum 10+ years’ 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.

Additional Skills:

• 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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