Clinical Trials - Medical Writer

Company Overview:

FIDELITY HEALTH SERVICES is a global pharmacovigilance company focused on patient safety and regulatory compliance. With offices in Toronto, London, Mumbai, Pune, and Ahmedabad, we deliver tech-driven safety and quality solutions to pharmaceutical and biopharmaceutical clients worldwide.

Role Summary:

Clinical Trial – Medical Writer Role in Mumbai

·      Responsible for Drafting, review, and finalize clinical trial documents including protocols, clinical study reports (CSRs), investigator brochures, and clinical overviews.

·      Prepare regulatory documents such as non-clinical overviews, clinical summaries, and trial synopses.

·       Collaborate with clinical, regulatory, biostatistics, and pharmacovigilance teams to collect and interpret data.

·      Conduct literature searches and prepare summaries to support medical and regulatory writing activities.

·      Develop and maintain templates, style guides, and standard operating procedures for document preparation.

·      Ensure all written materials adhere to company and regulatory standards (ICH, GCP, and relevant health authority guidelines).

·       Review and edit scientific content for accuracy, clarity, grammar, and consistency.

·      Contribute to the preparation of submission dossiers (e.g., IND, NDA, CTD modules) and responses to regulatory queries.

Key Requirements:

• Proficiency in preparing and reviewing documents such as protocols, CSRs, IBs, and CTD modules.
• Strong understanding of clinical research principles, ICH-GCP guidelines, and regulatory submission requirements.
• Bachelor’s or Master’s degree in Life Sciences, Pharmacy, Medicine, Biotechnology, or related discipline
• 2–5 years of hands-on experience in medical or regulatory writing (pharma, CRO, or medical device industry).
• Team-oriented with independent work capability