Novartis looking for Senior Associate Regulatory Writer | M.Pharm, M.Sc

Novartis has one of the most exciting product pipelines in the industry today. A pipeline of innovative medicines brought to life by diverse, talented and performance driven people. All of which makes them one of the most rewarding employers in their field.

Post : Senior Associate Regulatory Writer

Job Description
1. To write and/or edit high quality clinical and safety documents: non registration Clinical Study Reports (CSR), Development Safety Update Reports (DSUR), Clinical Trial Registry documents. Can contribute to Risk Management Plans (RMP).
2. Participate in planning of data analyses and presentation used in CSRs.
3. Documentation consultant in CTTs to ensure compliance of documentation to internal company standards and external regulatory guidelines.
4. Act as liaison between CTTs and publishing teams to ensure timely delivery of final documents for publishing.
5. Support the development of RWS through participating in RWS workstreams and other related activities.
6. Maintain audit, SOP and training compliance.
7. Delivery of high quality clinical and safety documents in time and in compliance with internal and external standards, according to RWS metrics.
8. Completion of an adequate volume of work (taking into account complexity) per year in accordance with the Key Performance Indicators.

Candidate Profile
1. Masters Degree in Science or Pharmacy with Minimum 3 years to 5 years of relevant experience in publishing/Regulatory Operations
2. Ability to plan and priorities workload
3. Ability to work in a matrix environment
4. Ability to build effective relationships across teams
5. Active command in English with excellent written and spoken communication skills
6. Good knowledge of Regulatory tools.
7. Adequate knowledge of software and computer tools.
8. Creative thinking and effective interdisciplinary collaboration with other functions.

Additional Information
Experience : 3-5 year
Qualification : M.Pharm, M.Sc
Location : Hyderabad, AP
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : R&D
End Date : 15th June, 2019