Medical Writing & Regulatory Jobs at Klin Health Bio | B Pharm, M Pharm, MSc

Medical Writing & Regulatory Hiring at Klin Health Bio

Are you an experienced professional in medical writing and regulatory affairs? Klin Health Bio Pvt Ltd is hiring talented candidates for its Medical Writing & Regulatory Department. If you have a background in B Pharm, M.Pharm, or MSc with 1-3 years of experience, this could be the perfect opportunity for you.

Why Join Klin Health Bio?

Klin Health Bio Research Pvt Ltd (KHBR) is a reputed organization in the pharmaceutical and clinical research sector. Working with us will provide hands-on experience in regulatory documentation and clinical trial submissions.

Job Details

Designation:

Medical Writing & Regulatory Department

Location:

India

 Qualification Required:

• B Pharm, M.Pharm, MSc

Experience Required:

• 1 to 3 years

Key Skills Required:

• Basic knowledge of medical writing
• Excellent communication skills
• Ready for immediate joining

Roles & Responsibilities

• Prepare and review Feasibility Assessment Reports as per sponsor and regulatory needs.
• Develop and review study Protocols, ensuring compliance with regulatory guidelines.
• Draft and edit Informed Consent Documents (ICD) in English and regional languages.
• Create Case Report Forms (CRF) following regulatory timelines.
• Collaborate with clinical, bioanalytical, and regulatory teams for document preparation.
• Interpret study outcomes in coordination with the Principal Investigator.
• Coordinate with Ethics Committees (EC) for study documentation submissions and approvals.
• Prepare & review SOPs to ensure compliance.
• Submit regulatory documents to the DCGI office for timely approvals of BA/BE studies.
• Support Head-Medical Writing in delegated responsibilities.

How to Apply?

If you meet the above requirements and are excited to join our team, send your updated CV to: hr@klinhealthbio.com

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