Immediate Start: 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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  • Clinical Trials

    7 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 –...

  • Clinical Trials

    2 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 –...

  • Clinical Quality Assurance Compliance

    21 hours ago

    Mumbai, Maharashtra, India Maxis Clinical Sciences Full time ₹ 20,00,000 - ₹ 25,00,000 per year

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    Mumbai, India Maxis Clinical Sciences Full time

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    1 week ago

    Mumbai, India Maxis Clinical Sciences Full time

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    2 days ago

    Mumbai, India Maxis Clinical Sciences Full time

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