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 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.
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.
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.
#medicalwriting #clinicaltrials #publishing #scientificdata #clinicalresearch #regulatory
