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Regulatory Writer (Expert / Senior)

About the Role

500! The number of regulatory documents we authored last year. As a Regulatory Writer (Senior or Expert level, depending on experience) you will write and review high quality clinical and safety documentation for submission to regulatory authorities. As an Expert Regulatory Writer you also will develop documents which cover all Novartis therapeutic areas and therapies, ranging from Phase I to IV Clinical Study Reports to regulatory submission documents (e.g. Clinical Summaries, Clinical Overview, Briefing Books, answers to Health Authority Questions) for New Drug Applications (NDA), supplemental NDAs, Marketing Authorization Applications and Type II variations.

Location: Basel, Switzerland #LI-Hybrid

Your responsibilities:
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.

Diversity & Inclusion / EEO

We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Role Requirements

• Minimum university life science degree or equivalent is required. Advanced degree or equivalent education/degree in life sciences/healthcare is desirable.
• 2- 6 years medical writing experience or other relevant pharma industry experience combined with scientific and regulatory knowledge, plus strong knowledge of the medical writing processes.
• Knowledge & experience in global regulatory environment and process (key regulatory bodies, key documents, approval processes, safety reporting requirements).
• Knowledge of process 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.

Why Novartis: Our purpose is to reimagine medicine to improve and extend people's lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here:
https://www.novartis.com/about/strategy/people-and-culture

You'll receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. https://www.novartis.com/careers/benefits-rewards

Accessibility and accommodation: Novartis is committed to working with and providing reasonable accommodation to all individuals. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to receive more detailed information about the essential functions of a position, please send an e-mail to
diversity.inclusion_ch@novartis.com and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network

Regulatory Writer (Expert / Senior)

Basel
Vollzeit

Veröffentlicht am 14.11.2023

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