Opportunity for M.Pharm, M.Sc as Senior Regulatory Writer at Novartis


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 Regulatory Writer

Job Description
1. To author, review and manage high quality clinical and safety documents: complex Clinical Study Reports (CSR), Development Safety Update Reports (DSUR), Risk Management Plans (RMP), submission documents (e.g., summaries of clinical efficacy and safety, summaries of clinical pharmacology and biopharmaceutics). 
2. Core member of Clinical Trial Team (CTT) / contributor to Safety Management Team. 
3. Major contributor to planning of data analyses and presentation used in CSRs and submission documents. 
4. Documentation specialist in CTTs and Clinical Submission Teams (CST) to ensure compliance of documentation to internal company standards and external regulatory guidelines. Provide content expertise and guidance for clinical portions of the CTD. 
5. Program Writer ensuring adequate medical writing resources are available for assigned program and consistency between documents. Extended member of International Clinical Team (ICT) 
6. Lead Writer for simple submissions, contributing to key messaging and pooling strategy, providing content guidance, and ensuring compliance of documentation to internal company standards and external regulatory guidelines. Core member of CST.  7.Contribute to process improvement in RWS and/or cross-functional initiatives or activities.

Candidate Profile
1. Masters Degree in Science or Pharmacy with Minimum 6 years to 10 years of relevant experience in medical writing
2. Advanced knowledge of and experience in global regulatory environment and process (key regulatory bodies, key documents, approval processes, safety reporting requirements).
3. Advanced knowledge of and repeat experience in global registration of drugs (complex submissions).
4. Ability to plan and priorities workload
5. Ability to work in a matrix environment
6. Ability to build effective relationships across teams
7. Active command in English with excellent written and spoken communication skills
8. Adequate knowledge of software and computer tools.
9. Creative thinking and effective interdisciplinary collaboration with other functions.

Additional Information
Experience : 6 years to 10 years
Qualification : M.Pharm, M.Sc
Location : Hyderabad, AP
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Research & Development
End Date : 20th June, 2019


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