Regulatory Writer

Jan 11, 2021

Job Description

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 and review high quality clinical and safety documentation for submission to regulatory authorities. Major Activities
1.To author and review high quality clinical and safety documents: non-registration Clinica lStudy 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.

Diversity & Inclusion / EEO

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 other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.

Minimum Requirements

Experience / Professional Requirement:
• Minimum university life science degree or equivalent is required. Advanced degree or equivalent education/degree in life sciences/healthcare is desirable.
• ≥ 2 years medical writing experience or other relevant pharma industry experience combined with scientific and regulatory knowledge, plus strong knowledge of the medical writing processes. Preferred
• 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)
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!
Global Drug Development
East Hanover, NJ
Research & Development
Full Time
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Regulatory Writer

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