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Medical Writer

3 weeks ago

Hyderabad, India Advity Research Full time

Hyderabad 3 to 5 years Full Time

**Department**:
BA/BE & Clinical Trials

**Education Qualification**:
Graduate/Post Graduate/Doctorate degree in Life Sciences/Pharmacy/Medical Sciences or equivalent degree. Fluency in English.

**Mode of work**:
On premise
- Overall management and co-ordination of MW activities performed by the MW department.
- Interact cross-functionally with other departments (e.g. Clinical Operations, Medical Affairs, QA, PM) to ensure the timely completion of high quality deliverables.
- Ensure that all work done by the MW department is conducted in compliance with Advity.
- Research Policies, SOPs and relevant guidance’s and guidelines.
- Write and review protocols, ICFs and Clinical study reports for Phase I-IV studies (e.g. PK, FIM, BE/BA, safety), as needed.
- 5Set up and monitor assigned project timelines by maintaining department scheduling tools.
- Represent Advity in discussions with sponsors, at conferences and client meetings.
- Work with the Quality Assurance group in the development/revision and implementation of
- Standard Operating Procedures as required.
- Acquire and maintain knowledge of national and international guidelines.
- Participate in training sessions.
- Work in a safe manner that does not endanger yourself of co-workers.
- Execute other duties as may be required by management of Advity as training and experience allow