Senior Regulatory Medical Writer - Greater London - Coronado Research

    Coronado Research
    Coronado Research Greater London

    2 days ago

    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:

    • 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.

    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.

    Seniority level


    Mid-Senior level

    Employment type


    Full-time

    Job function


    Science

    Industries


    Pharmaceutical Manufacturing and Biotechnology Research


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