Clinical Trials
3 weeks ago
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 Trial Associate
6 days ago
Mumbai, Maharashtra, India Novartis Full time**Summary**: Designs and coordinates the overall direction of clinical development projects. Coordinates activities of associates and investigators to ensure compliance with protocol and overall pre-clinical objectives. Maintains a high level of professional expertise through familiarity with clinical literature and participates in project team meetings. May...
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Clinical Trial Monitor
2 weeks ago
Mumbai, India Bristol Myers Squibb Full time**Working with Us** Challenging. 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...
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Clinical Trials
3 weeks ago
Mumbai, India FIDELITY HEALTH SERVICES Full timeCompany 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 –...
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Clinical Trials
3 weeks ago
Mumbai, India FIDELITY HEALTH SERVICES Full timeCompany 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 –...
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Clinical Trial Associate
2 weeks ago
Mumbai, India Novartis Full time100,000+ That’s how many patients participate in our clinical trials at any given time. GCO is Novartis’ powerhouse of Global Clinical Operations, redesigned to enable faster trial recruitment and enhanced trial delivery resulting in more timely access for patients to potential novel treatments. Every day, we are the link between science and medicine -...
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Clinical Quality Assurance Compliance
3 weeks ago
Mumbai, India Maxis Clinical Sciences Full timeJob Title: Clinical Quality Assurance Compliance & training Experience: 5 plus years Location: Mumbai Type: Full-time Experience Level: [Senior] Manager/Senior Manager Department: 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...
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Clinical Quality Assurance Compliance
3 weeks ago
Mumbai, India Maxis Clinical Sciences Full timeJob Title: Clinical Quality Assurance Compliance & training Experience : 5 plus years Location: Mumbai Type: Full-time Experience Level: (Senior) Manager/Senior Manager Department: 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...
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Clinical Quality Assurance Compliance
2 weeks ago
Mumbai, India Maxis Clinical Sciences Full timeJob 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...
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Clinical Quality Assurance Compliance
2 weeks ago
Mumbai, India Maxis Clinical Sciences Full timeJob 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...
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Clinical Quality Assurance Compliance
3 weeks ago
Mumbai, India Maxis Clinical Sciences Full timeJob 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...
