Are you passionate about clinical research and scientific documentation? Fidelity Health Services Pvt. Ltd., a leading healthcare and clinical research organization based in Ahmedabad, is hiring for the Clinical Trials – Medical Writer position.
This is a full-time, on-site opportunity ideal for professionals with experience in medical writing, regulatory documentation, and clinical research. If you have a flair for scientific writing and a strong understanding of global clinical standards, this role is for you.
Key Responsibilities
As a Clinical Trials Medical Writer, you will play a vital role in developing and managing regulatory and clinical documents that support Fidelity Health Services’ global submissions.
Your responsibilities include:
- Drafting, reviewing, and finalizing clinical trial documents such as protocols, CSRs, investigator brochures, and clinical overviews.
- Preparing regulatory documents including clinical summaries, non-clinical overviews, and trial synopses.
- Collaborating with clinical, regulatory, biostatistics, and pharmacovigilance teams for data interpretation and document preparation.
- Conducting literature reviews and analyzing data to support writing activities.
- Assisting in the preparation of submission dossiers (IND, NDA, CTD modules) and responses to regulatory authorities.
Qualifications and Skills
To qualify for this position, you should have:
- A Bachelor’s or Master’s degree in Life Sciences, Pharmacy, Medicine, Biotechnology, or related discipline.
- 2–5 years of experience in medical or regulatory writing (pharma, CRO, or medical device industry).
- Strong understanding of ICH-GCP, CTD format, and global submission standards.
- Excellent written and verbal communication skills.
- Ability to manage multiple writing projects under tight timelines.
Why Join Fidelity Health Services?
At Fidelity Health Services, you’ll be part of a passionate team that’s shaping the future of healthcare research and regulatory excellence.
Benefits include:
- Competitive salary and growth opportunities.
- Exposure to international regulatory writing projects.
- Collaborative, learning-driven work environment.
- Opportunity to contribute to impactful clinical research documentation.
How to Apply
Send your CV to: hrrecruitment@fidelityhs.com
