Clinical Trials

4 hours ago

Mumbai, India FIDELITY HEALTH SERVICES Full time

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: Full-time, on-site 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

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    2 days ago

    Mumbai, India Maxis Clinical Sciences Full time

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