Novartis Ireland Dublin Ireland
2 weeks ago
500! The number of regulatory documents we authored last year. As a Regulatory Writer you will write and review high quality clinical and safety documentation for submission to regulatory authorities.
Your responsibilities include, but are not limited to:
• 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).
• Lead for outsourced Narrative projects. Coordinate other outsourced activities in RWS.
• Core member of Clinical Trial Team (CTT) / participate in Safety Management Team(SMT).
• Actively participate in planning of data analyses and presentation used in CSRs.
• Act as documentation consultant in CTTs and SMTs to ensure compliance of documentation to internal company standards and external regulatory guidelines.
• May act as Program Writer ensuring adequate medical writing resources are available for assigned... program and consistency between documents.
• Act as liaison between CTTs and publishing teams to ensure timely delivery of final documents for publishing.
• Support the development of RWS through participating in RWS workstreams and other related activities.
• Contribute to development of processes within RWS. May contribute to cross-functional initiatives.
• Fostering cross-functional communication to optimize feedback and input towards high quality documents.
• Maintain audit, SOP and training compliance.
Commitment to Diversity & Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
• Minimum university life science degree or equivalent is required. Advanced degree or equivalent education/degree in life sciences/healthcare is desirable.
• Approximately 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.
• 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.
Competitive salary, Annual bonus, Pension scheme, Share scheme, Health insurance, 25 days annual leave, Flexible working arrangements, subsidized dining facilities, Employee recognition scheme, learning and development opportunities.
Why consider Novartis?
236 million. That’s how many lives our products touched in 2022. 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.
Imagine what you could do at Novartis!
Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network
We are Novartis. Join us and help reimagine medicine.
Global Drug Development
Novartis Ireland Limited
Research & Development
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