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Medical Writer

2 weeks ago

Pune Maharashtra, India Docthub Health Tech Private Limited Full time

**Position: Medical Writer**

**Experience: 2- 5 Years**

**Locations -Pune, Maharashtra**

**Educational Qualifications: MPharm Pharmaceutics, MSc (Master of Science), BPharm (Bachelor Of Pharmacy)**

**About Company: It is Health Care Industry**

**Description**

**Skills**:

- Ready for immediate Joining.

**Responsibilities**:

- Preparation and review of Feasibility Assessment Report as per sponsor and regulatory requirements.
- Preparation and review of Protocol as per sponsor and regulatory requirements.
- Preparation and review of Informed Consent Document (ICD) in English and vernacular language according to protocol.
- Preparation a Case Report Form (CRF) within proposed time line as per the regulatory requirements.
- 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.
- Interpretation of study outcome in coordination with Principal Investigator.
- Coordination with Ethics Committee (EC) in submission of study related document and obtain approval.
- Preparation and review of in-house Standard Operating Procedure (SOP).
- Ensure the submission of DCGI NOC documents to the office of DCGI for BA/BE studies for requisite approval on time.
- Any other responsibility delegated by Head-Medical Writing.

**Salary**: Up to ₹50,000.00 per month

Schedule:

- Day shift

**Experience**:

- total work: 1 year (preferred)

Ability to Commute:

- Pune, Maharashtra (required)

Ability to Relocate:

- Pune, Maharashtra: Relocate before starting work (required)

Work Location: In person

**Speak with the employer**

+91 95102 02546