Senior Regulatory Writer
- Hyderabad, India
900! 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.
Your responsibilities include, but are not limited to:
• 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).
• Core member of Clinical Trial Team (CTT) / contributor to Safety Management Team. Major contributor to planning of data analyses and presentation used in CSRs and submission documents.
• 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.
• Program Writer ensuring adequate medical writing resources are available for assigned program and consistency between documents. Extended member of International Clinical Team (ICT)
• 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.
• 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.
• ≥ 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 (key regulatory bodies, key documents, approval processes, safety reporting requirements).
• Advanced knowledge of and repeat experience in global registration of drugs (complex submissions).
• 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.
• Proven track record in matrix environment. Some experience in managing global, cross-functional teams or simple global projects. Ability to motivate and coach people.
Why consider Novartis?
799 million. That's how many lives our products touch. And while we're proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people's lives?
We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment. Where you're given opportunities to explore the power of digital and data. Where you're empowered to risk failure by taking smart risks, and where you're surrounded by people who share your determination to tackle the world's toughest medical challenges.
We are Novartis. Join us and help us reimagine medicine.
Novartis are an equal opportunities employer and welcome applications from all suitably qualified persons.
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