Associate Director Regulatory Writer
- East Hanover, NJ
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?
To write, review and/or handle the production of high quality clinical and safety documentation for submission to regulatory authorities in support of marketing applications. To provide authoritative documentation-related consultancy to other line functions. To coach/mentor and/or train less experienced writers.
1. To author, review and/or independently handle high quality clinical and safety documents: Clinical Study Reports (CSR), Risk Management Plans (RMP), CTD submission documents (clinical overviews, summaries of clinical efficacy and safety, summaries of clinical pharmacology and biopharmaceutics), other documents for health authorities (e.g., Briefing Books, answers to questions).
2. Lead writing team for complex submissions, actively contributing to key messaging and pooling strategy, providing specialist content guidance for clinical portions of the CTD, and ensuring compliance of documentation to internal company standards and external regulatory guidelines.
3. Ad-hoc member of Clinical Trial Team (CTT) / extended member of Safety Management Team (SMT). Core member of multiple Clinical Submission Teams (CST). Extended member of Global Clinical Teams (GCT).
4. Input into planning of data analyses and presentation (statistical analysis plan review and meetings) used in CSRs, submission documents and/or answers to questions.
5. Documentation specialist in GCTs and CSTs to ensure compliance to internal company standards and external regulatory guidelines. Provide content and strategic expertise for clinical portions of the CTD.
6. Program Writer for large and/or complex programs ensuring adequate medical writing resources are available for assigned program and consistency between documents.
7. Lead process improvement in RWS and cross-functional initiatives and/or activities.
EEO Statement The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.
• Minimum university life science degree or equivalent is required. Advanced degree or equivalent education/degree in life sciences/healthcare is desirable.
• ≥ 6 years medical writing experience or other relevant pharma industry experience combined with scientific and regulatory knowledge, plus expert knowledge of medical writing processes. preferred
• Expert knowledge of and repeat experience in global regulatory environment and process (key regulatory bodies, key documents, approval processes, safety reporting requirements).
• Expert knowledge, extensive experience, and demonstrated record of accomplishment in global registering of drugs.
• Excellent communication skills (written, verbal, presentations)
• Expert knowledge of biostatistics principles.
Why consider Novartis?
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.
Imagine what you could do at Novartis!
Back to top