Clinical Trial Medical Writer – Fidelity Health Services
- Company Overview
- Job Role & Responsibilities
- Eligibility / Qualifications
- Location & Salary
- Application Process
- Why Join Fidelity Health Services?
- Frequently Asked Questions (FAQs)
Clinical Trial Medical Writer – Fidelity Health Services
Apply for the Clinical Trial Medical Writer role at Fidelity Health Services, Mumbai. Ideal for Life Science graduates with 2–5 years’ experience.
Fidelity Health Services is seeking an experienced Clinical Trial Medical Writer to join its growing global pharmacovigilance and clinical research documentation team in Mumbai, India. This is a full-time, on-site opportunity for talented professionals passionate about advancing patient safety and regulatory excellence.
Fidelity Health Services is recognized for its global footprint with offices in Toronto, London, Mumbai, Pune, and Ahmedabad, offering tech-driven safety and compliance solutions to leading pharmaceutical and biopharmaceutical companies. The company is known for its strong regulatory expertise, innovation in pharmacovigilance services, and a commitment to high-quality documentation that supports clinical trial transparency and compliance.
Company Overview
Fidelity Health Services is a trusted name in pharmacovigilance, medical writing, and regulatory compliance. With an expanding international presence, the company helps pharma and biotech clients achieve excellence in drug safety reporting, clinical documentation, and regulatory submissions. Fidelity’s team of experts ensures compliance with global health authority standards including ICH, GCP, EMA, and USFDA.
By integrating data-driven insights and automation tools, Fidelity is redefining how safety and compliance workflows are executed in clinical research. Its focus on quality, reliability, and timely delivery makes it a preferred partner for many top-tier life science organizations.
Job Role & Responsibilities
As a Clinical Trial – Medical Writer, you will play a critical role in ensuring the accuracy, clarity, and compliance of clinical trial documentation. Your responsibilities include:
- Drafting, reviewing, and finalizing key clinical trial documents such as protocols, Clinical Study Reports (CSRs), Investigator Brochures (IBs), and Clinical Overviews.
- Preparing regulatory documents including non-clinical overviews, trial synopses, and Clinical Trial Dossiers (CTDs).
- Collaborating with cross-functional teams—clinical, regulatory, biostatistics, and pharmacovigilance—to interpret and compile data.
- Conducting literature searches and summarizing findings to support regulatory and scientific writing.
- Developing and maintaining document templates, style guides, and SOPs for medical writing consistency.
- Ensuring all materials meet regulatory standards (ICH, GCP) and internal quality assurance guidelines.
- Supporting the preparation of submission dossiers (IND, NDA, CTD modules) and handling responses to regulatory authority queries.
Eligibility / Qualifications
- Education: Bachelor’s or Master’s degree in Life Sciences, Pharmacy, Medicine, or Biotechnology (B.Pharm, M.Pharm, M.Sc Life Sciences, MBBS, BDS, B.Tech Biotech, M.Tech Biotech).
- Experience: 2–5 years of proven experience in medical or regulatory writing within the pharma, CRO, or medical device industry.
- Technical Skills: Proficiency in preparing CSRs, IBs, CTD modules, and regulatory summaries.
- Strong grasp of clinical research principles, ICH-GCP, and submission requirements.
- Excellent written communication, analytical thinking, and collaboration skills.
Location & Salary
- Location: Mumbai, Maharashtra (On-site)
- Work Type: Full-time
- Salary: Competitive, based on experience and industry standards
Application Process
Interested candidates can apply directly via the official LinkedIn listing:
👉 Apply Here
Apply early to secure your spot — limited openings available!
Why Join Fidelity Health Services?
- Work with global pharmaceutical leaders on high-impact projects.
- Gain hands-on experience in regulatory submissions and pharmacovigilance documentation.
- Develop expertise in clinical research writing and compliance.
- Be part of a growth-oriented, technology-driven organization.
Frequently Asked Questions (FAQs)
1. Who can apply for this position?
Candidates with a degree in Life Sciences, Pharmacy, Biotechnology, or Medicine and 2–5 years of relevant experience can apply.
2. What type of documents will I work on?
You’ll handle protocols, CSRs, IBs, CTDs, and regulatory summaries.
3. Is this a remote or on-site job?
This role is on-site in Mumbai, ensuring close collaboration with project and regulatory teams.
4. How can I apply?
You can apply directly through Fidelity’s LinkedIn page.
5. What is the average salary for this role?
The salary is competitive and depends on your experience and expertise in clinical or regulatory writing.
| Category | Details |
|---|---|
| Company | Fidelity Health Services |
| Vacancy | Clinical Trial – Medical Writer |
| Required Education | B.Pharm, M.Pharm, M.Sc Life Sciences, MBBS, BDS, B.Tech/M.Tech Biotech |
| Experience | 2–5 years (Medical or Regulatory Writing) |
| Location | Mumbai, Maharashtra (On-site) |
| Apply Link | Click Here to Apply |
To apply for this job please visit www.linkedin.com.
