
Medical Writing
2 weeks ago
**Company Name**: Klin Health Bio Pvt Ltd
**Designation**: medical writing and regulatory department.
**Qualification**: B.Pharm/M.Pharm/MSc
**Experience**: 0 to 3 years
**Skills**:
3. Ready for immediate Joining.
**Responsibilities**:
1. Preparation and review of Feasibility Assessment Report as per sponsor and regulatory requirements.
2. Preparation and review of Protocol as per sponsor and regulatory requirements.
3. Preparation and review of Informed Consent Document (ICD) in English and vernacular language according to protocol.
4. Preparation a Case Report Form (CRF) within proposed time line as per the regulatory requirements.
5. Coordination with clinical, Bio analytical department and principal and co-investigators, and other respective departments while preparation of Protocol, Feasibility Assessment Report, Informed Consent Document and Case Report Form.
6. Interpretation of study outcome in coordination with Principal Investigator.
7. Coordination with Ethics Committee (EC) in submission of study related document and obtain approval.
8. Preparation and review of in-house Standard Operating Procedure (SOP).
**9. **Ensure the submission of DCGI NOC documents to the office of DCGI for BA/BE studies for requisite approval on time.
**10. **Any other responsibility delegated by Head-Medical Writing.
**Salary**: ₹15,000.00 - ₹50,000.00 per month
**Benefits**:
- Health insurance
- Provident Fund
Schedule:
- Day shift
- Morning shift
**Experience**:
- total work: 1 year (preferred)
Ability to Commute:
- Wagholi, Pune, Maharashtra (required)
Ability to Relocate:
- Wagholi, Pune, Maharashtra: Relocate before starting work (required)
Work Location: In person
**Speak with the employer**
+91 9766135872
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