Medical Writing

1 week ago

Ahmedabad, India Cliantha Research Full time

**Position: Medical Writer**

**Department **Medical Writing

**Basic qualification required **B.Pharm / M. Pharm, M.Sc

**Brief JDs Job Description:
- Responsible for preparation/review of the Study Synopsis.
- Responsible for preparation/review of the Study Protocol.
- Responsible for preparation/review of the Investigator's Brochure.
- Responsible for preparation/review of lCD, assent form and- Responsible for preparation/review of the clinical study report
- and other dossier related documents.- Responsible for interacting with KOL for inputs for Protocol

writing, Data monitoring committees, and other regulatory
requirements.
- Regular interactions with sponsor's team for preparation of

stussdy related documents, presentations, etc.
- To prepare/review departmental SOP under the guidance of the

departmental Head/QA.
- Preparation/review of documents for regulatory submission like

executive summary, and presentation for expert committee
meeting.
- Preparation/review of Non-clinical Overview (Module 2.4), Clinical

Overview (Module 2.5), Module 2. 7 and briefing doctunents.
- Design and development of manuscript.
- Coordinate with business development, clinical data management
and clinical operations teams for timely closure of medical writing
inputs.

Any additional responsibility given by Head of the
Department/Management

USA | CANADA | EUROPE | INDIA

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