Are you a skilled professional with a background in pharmacy or science, eager to contribute to the medical writing and regulatory field? Klin Health Bio Pvt Ltd is seeking talented individuals to join our Medical Writing and Regulatory Department. If you have 1-3 years of experience and a passion for precision and communication, this could be your next career move!
About Klin Health Bio Pvt Ltd
Klin Health Bio Pvt Ltd is a dynamic organization dedicated to advancing healthcare through excellence in clinical research, regulatory compliance, and bioanalytical services. We are looking for motivated candidates to support our mission of delivering high-quality outcomes in the pharmaceutical and biotechnology sectors.
Job Opening: Medical Writing & Regulatory Department
We are hiring for the position of Medical Writer in our Regulatory Department. This role offers an opportunity to work on critical documentation and collaborate with cross-functional teams to ensure regulatory compliance and study success.
Job Details
| Field | Details |
|---|---|
| Designation | Medical Writing & Regulatory Department |
| Qualification | B.Pharm / M.Pharm / M.Sc |
| Experience | 1 to 3 years |
| Email for CV | hr@klinhealthbio.com |
Required Skills
- Basic knowledge of medical writing
- Excellent communication skills (written and verbal)
- Ability to join immediately
Job Responsibilities
- Prepare and review Feasibility Assessment Reports per sponsor and regulatory requirements.
- Develop and review Protocols aligned with sponsor and regulatory guidelines.
- Create and review Informed Consent Documents (ICD) in English and vernacular languages as per protocol.
- Design Case Report Forms (CRF) within proposed timelines, adhering to regulatory standards.
- Coordinate with clinical, bioanalytical, and investigative teams during the preparation of Protocols, Feasibility Reports, ICDs, and CRFs.
- Interpret study outcomes in collaboration with the Principal Investigator.
- Liaise with the Ethics Committee (EC) for submission and approval of study-related documents.
- Draft and review in-house Standard Operating Procedures (SOPs).
- Ensure timely submission of DCGI NOC documents to the DCGI office for BA/BE study approvals.
- Handle additional responsibilities as assigned by the Head of Medical Writing.
How to Apply
If you’re ready to make an impact and meet the qualifications, we’d love to hear from you! Please send your updated CV to:
Email: hr@klinhealthbio.com
Contact Us
For further details, reach out to:
Email: hr@klinhealthbio.com
Application Deadline: Open until position is filled
Join Klin Health Bio Pvt Ltd and contribute to groundbreaking work in medical writing and regulatory affairs. We look forward to welcoming you to our team!
