Clinical Trials

7 days 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 discipline2–5 years of hands-on experience in medical or regulatory writing (pharma, CRO, or medical device industry).Team-oriented with independent work capability

  • Clinical Quality Compliance

    4 days ago

    Mumbai, Maharashtra, India Maxis Clinical Sciences Full time ₹ 15,00,000 - ₹ 28,00,000 per year

    This role will be responsible for oversight on end-to-end clinical trial activities from quality perspective. This role will be accountable for Quality Compliance (QC) activities of Clinical Trial Medical Science team and Operations team, Clinical Trial Supply Management (CTSM) team, and Clinical Data Management team by way of Review of all study related...

  • Clinical Trial Manager

    2 weeks ago

    Navi Mumbai, Maharashtra, India Medpace Full time ₹ 9,00,000 - ₹ 12,00,000 per year

    Medpace is currently looking forClinical Trial Manager (CTM)to lead global clinical research studies. This position is fully office-based in our Mumbai, India office. Medpace is a scientifically led organization involved in full services for our clients, giving the Medpace project teams the empowerment to truly lead and execute clinical...

  • Clinical Quality Assurance Compliance

    1 week ago

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

    Job Title:Clinical Quality Assurance Compliance & trainingExperience: 5 plus yearsLocation:MumbaiType:Full-timeExperience Level:[Senior] Manager/Senior ManagerDepartment:Clinical Research DepartmentPurpose of this Role:This role will be responsible for oversight on end-to-end clinical trial activities from quality perspective. This role will be accountable...

  • Clinical Trials

    1 week 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

    1 week 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

    7 days 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 Trial Coord

    2 weeks ago

    Mumbai, India PPD Full time

    We are vital links between an idea for a new medicine and the people who need it. We are the people of PPD — thousands of employees in locations worldwide connected by tenacity and passion for our purpose: to improve health. You will be joining a truly collaborative and winning culture as we strive to bend the time and cost curve of delivering life-saving...

  • Clinical Trial Manager

    6 days ago

    Mumbai, Maharashtra, India Bristol Myers Squibb Full time ₹ 6,00,000 - ₹ 12,00,000 per year

    Working with UsChallenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the...

  • Clinical Quality Assurance Compliance

    3 weeks ago

    Mumbai, India Maxis Clinical Sciences Full time

    Job Title: Clinical Quality Assurance Compliance & training Experience : 5 plus yearsLocation: MumbaiType: Full-timeExperience Level: (Senior) Manager/Senior ManagerDepartment: Clinical Research DepartmentPurpose of this Role:This role will be responsible for oversight on end-to-end clinical trial activities from quality perspective. This role will be...

  • Clinical Quality Assurance Compliance

    7 days ago

    Mumbai, India Maxis Clinical Sciences Full time

    Job Title: Clinical Quality Assurance Compliance & trainingExperience: 5 plus yearsLocation: MumbaiType: Full-timeExperience Level: [Senior] Manager/Senior ManagerDepartment: Clinical Research Department Purpose of this Role:This role will be responsible for oversight on end-to-end clinical trial activities from quality perspective. This role will be...