Senior Regulatory Writer

Job ID REQ-10012472
Jun 24, 2024
India

Summary
That is the approximate number of individual regulatory documents the dynamic team at Regulatory Writing and Submissions (RWS) planned, developed and wrote. And that’s just in 2019! Come, join a global team of nearly 200 regulatory professionals- life scientists, clinicians and project managers across 6 countries and support Novartis in its mission to bring innovative medicines to patients worldwide. You will collaborate with colleagues from Statistics, Data Management and Clinical Development and have the opportunity to analyze data and derive key messaging to secure approvals from Health Authorities. Read on for details about the role and how you can join a world-class organization at the forefront of the industry to advance your career.

About the Role

Position Title : Senior Regulatory Writer

That is the approximate number of individual regulatory documents the dynamic team at Regulatory Writing and Submissions (RWS) planned, developed and wrote. And that’s just in 2019! Come, join a global team of nearly 200 regulatory professionals- life scientists, clinicians and project managers across 6 countries and support Novartis in its mission to bring innovative medicines to patients worldwide. You will collaborate with colleagues from Statistics, Data Management and Clinical Development and have the opportunity to analyze data and derive key messaging to secure approvals from Health Authorities. Read on for details about the role and how you can join a world-class organization at the forefront of the industry to advance your career.

Key Responsibilities:
• 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.

• Core member of Clinical Trial Team (CTT) / contributor to Safety Management Team. Documentation specialist in CTTs and Clinical Submission Teams (CST) to ensure compliance of documentation to internal company standards and external regulatory guidelines.

• Program Writer ensuring adequate medical writing resources are available for assigned program and consistency between documents.

• 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.

• Contribute to process improvement in RWS and/or cross-functional initiatives or activities. Coach and/or mentor less experienced writers.

• Leader in cross-functional communication to optimize feedback and input towards high quality documents. Maintain audit, SOP and training compliance.

Role Requirements :
Essential Requirements:

• ≥ 4 years medical writing experience or other relevant pharma industry experience combined with scientific and regulatory knowledge, plus in-depth knowledge of medical writing processes.

• Advanced knowledge of and experience in global regulatory environment and process.

• Excellent communication skills (written, verbal, presentations). Advanced knowledge of biostatistics principles.

• Strong ability to prioritize and manage multiple demands and projects. Ability to define and solve complex problems (“Problem-solver”)

• Broad knowledge and future oriented perspective. Ability to drive and manage organizational and team performance across cultures.