Regulatory Writer

17 hours ago

Hyderabad, Telangana, India Sandoz Full time
Job Description

Major accountabilities:

- To author and review high quality clinical and safety documents: non-registration Clinical Study Reports (CSR), Development Safety Update Reports (DSUR), Risk Management Plans (RMP).
- 2. Lead for outsourced Narrative projects. Coordinate other outsourced activities in RWS.
- 3. Core member of Clinical Trial Team (CTT) / participate in Safety Management Team (SMT).
- 4. Actively participate in planning of data analyses and presentation used in CSRs.
- 5. Act as documentation consultant in CTTs and SMTs to ensure compliance of documentation to internal company standards and external regulatory guidelines.
- 6. May act as Program Writer ensuring adequate medical writing resources are available for assigned program and consistency between documents.
- 7. Act as liaison between CTTs and publishing teams to ensure timely delivery of final documents for publishing.
- 8. Support the development of RWS through participating in RWS workstreams and other related activities.
- 9. Contribute to development of processes within RWS. May contribute to cross-functional initiatives.
- 10. Fostering cross-functional communication to optimize feedback and input towards high quality documents.
- 11. Maintain audit, SOP and training compliance.

Key performance indicators:

- Delivery of high quality clinical and safety documents in time and in compliance with internal and external standards -Customer / partner/ project feedback and satisfaction -Adherence to Novartis policy and guidelines

Minimum Requirements:

Work Experience:

- Minimum 3-5 years of medical writing experience or 1-3 years of experience with MBBS/PhD.
- Good knowledge of and some experience in global regulatory environment and process (key regulatory bodies, key documents, approval processes, safety reporting requirements).
- Knowledge of process for and some experience in global registering of drugs (simple submissions).
- Excellent communication skills (written, verbal, presentations) Very good understanding of biostatistics principles.
- Ability to prioritize and manage multiple demands and projects.
- Ability to define and solve complex problems ( Problemsolver )
- Broad knowledge and future oriented perspective
- Proven track record in matrix environment
- Experience in contributing to global, cross-functional projects.
- Global, cross-cultural perspective and customer orientation

Skills Desired

Clinical Research, Clinical Trials, Detail-Oriented, Medical Writing, Regulatory Compliance, Safety

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