Prime Services CRO is seeking experienced Clinical Regulatory Medical Writers for its team in Ahmedabad, Gujarat. Candidates with at least one year of relevant experience in clinical research, regulatory medical writing, and regulatory document authoring and quality control (QC) can apply.
The position requires experience preparing and reviewing Clinical Study Reports (CSR), Investigator’s Brochures (IB), and Clinical Study Protocols. Immediate joiners and candidates serving a short notice period are preferred.
Job Details
| Particulars | Details |
|---|---|
| Company | Prime Services CRO |
| Job Title | Clinical Regulatory Medical Writer |
| Location | Ahmedabad, Gujarat |
| Experience Required | Minimum 1+ year of relevant experience |
| Preferred Joining | Immediate joiners or candidates with a short notice period |
| Application Mode | |
| Email Address | dolly.sakariya@primeservicescro.com |
Position: Clinical Regulatory Medical Writer
The role focuses on clinical and regulatory medical writing, including authoring and quality-checking regulatory documents used in clinical research.
Key Responsibilities and Work Areas
Candidates should have experience in:
- Authoring and quality control of Clinical Study Reports (CSR).
- Preparing and reviewing Investigator’s Brochures (IB).
- Authoring and QC of Clinical Study Protocols.
- Clinical trials and regulatory medical writing.
- Reviewing, editing, and quality-checking scientific and regulatory documents.
Eligibility and Requirements
Candidates applying for the Clinical Regulatory Medical Writer position should have:
- A minimum of one year of relevant experience.
- Hands-on experience in clinical trials and regulatory medical writing.
- Experience authoring and performing QC of regulatory documents, including CSR, IB, and Clinical Study Protocols.
- A strong understanding of clinical research and regulatory documentation requirements.
- Excellent scientific writing, reviewing, editing, and quality-checking skills.
Important: Candidates with only Bioavailability/Bioequivalence (BA/BE) experience will not be considered.
Required Skills
- Clinical regulatory medical writing.
- Clinical Study Report (CSR) authoring and QC.
- Investigator’s Brochure (IB) documentation.
- Clinical Study Protocol authoring and QC.
- Scientific writing, editing, reviewing, and quality control.
- Understanding of clinical research and regulatory documentation requirements.
How to Apply for Clinical Regulatory Medical Writer Jobs in Ahmedabad
Interested candidates with the required experience can share their updated CV via email.
Email: dolly.sakariya@primeservicescro.com
Immediate joiners and candidates with a short notice period are preferred.
