Description

Medical Writer PRINCIPAL DUTIES AND RESPONSIBILITIES: 1. Responsible for preparation/review of the Study Synopsis. 2. Responsible for preparation/review of the Study Protocol. 3. Responsible for preparation/review of the Investigator's Brochure. 4. Responsible for preparation/review of lCD, assent form and subject diary. 5. Responsible for preparation/review of the clinical study report and other dossier related documents. 6. Responsible for interacting with KOL for inputs for Protocol writing, Data monitoring committees, and other regulatory requirements. 7. Regular interactions with sponsor's team for preparation of study related documents, presentations, etc. 8. To prepare/review departmental SOP under the guidance of the departmental Head/QA. 9. Preparation/review of documents for regulatory submission like executive summary, and presentation for expert committee meeting. 10. Preparation/review of Non-clinical Overview (Module 2.4), Clinical Overview (Module 2.5), Module 2. 7 and briefing documents. 11. Design and development of manuscript. 12. 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

Role and Responsibilities

• Medical Writer PRINCIPAL DUTIES AND RESPONSIBILITIES: 1. Responsible for preparation/review of the Study Synopsis. 2. Responsible for preparation/review of the Study Protocol. 3. Responsible for preparation/review of the Investigator's Brochure. 4. Responsible for preparation/review of lCD, assent form and subject diary. 5. Responsible for preparation/review of the clinical study report and other dossier related documents. 6. Responsible for interacting with KOL for inputs for Protocol writing, Data monitoring committees, and other regulatory requirements. 7. Regular interactions with sponsor's team for preparation of study related documents, presentations, etc. 8. To prepare/review departmental SOP under the guidance of the departmental Head/QA. 9. Preparation/review of documents for regulatory submission like executive summary, and presentation for expert committee meeting. 10. Preparation/review of Non-clinical Overview (Module 2.4), Clinical Overview (Module 2.5), Module 2. 7 and briefing documents. 11. Design and development of manuscript. 12. 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