Vimta Labs Ltd, a well-established name in clinical research and analytical services, is inviting applications for the role of Medical Writer – Clinical Trials at its Hyderabad (Cherlapally) facility. This opportunity is ideal for experienced medical writers with strong expertise in clinical trial protocol design, regulatory medical writing, and eCTD submissions, particularly in biosimilars and PK/PD studies.
This role offers a chance to work closely with statisticians, sponsors, regulatory authorities, and ethics committees on high-impact clinical research projects.
🔍 Key Responsibilities
As a Medical Writer – Clinical Trials, the selected candidate will be responsible for:
- Designing and writing clinical trial protocols for Phase I–IV studies
- Preparing Informed Consent Forms (ICF) as per regulatory and ethical guidelines
- Reviewing and developing CRF / eCRF documents
- Writing and reviewing clinical study reports (CSR)
- Supporting eCTD documentation for regulatory submissions
- Collaborating with statisticians for data analysis and interpretation of study results
- Handling queries from sponsors, regulatory authorities, and ethics committees
- Ensuring compliance with ICH-GCP, CDSCO, and global regulatory standards
🎓 Qualifications & Experience
To be eligible for this role, candidates must meet the following criteria:
- 7–12 years of experience in medical writing for clinical trials
- Proven expertise in protocol design, especially for PK/PD and biosimilar studies
- Strong experience in regulatory medical writing and eCTD submissions
- Hands-on exposure to clinical study report writing
- Excellent understanding of global clinical research regulations
- Experience limited to BA/BE studies will NOT be considered
- Additional regulatory writing experience is a plus
💼 Salary & Benefits
- Competitive salary ranging from ₹5 to ₹10 LPA, based on experience
- Opportunity to work with a reputed CRO and testing organization
- Exposure to regulatory submissions and global clinical trials
- Professional growth in a scientific and compliance-driven environment
📩 How to Apply
Interested and eligible candidates can apply by sharing their updated resume via email:
Email: keerthana.rojanala@vimta.com