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 : 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