Summary
About the Role
Major accountabilities:
Lead the preparation of initial Risk Management Plans (RMPs) and other aggregates reports as required for newly launched, acquired products, or new indications RMP update. Drive key messaging and pooling strategy, offering expert content guidance for RMP documents.
Lead coordination to ensure information received, analyzed and incorporated into RMP updates as per the regulatory requirements.
Independent QC of deliverables to ensure the information presented is complete, consistent and compliant to regulatory and Novartis standards.
Provide support to the planning of data analyses and presentation, including statistical analysis plan reviews and meetings, for RMP submissions.
Support in creating strategy for data analyses and presentation in global periodic safety reports and other department’ deliverables as required; as well as in addressing the Health Authority (HA) comments adequately in deliverables, or SOPs.
Support in the development of safety document templates and Standard Operating Procedures pertaining to the department’s deliverables.
Contribute to global projects focusing on process, system & quality improvement initiatives (including AI projects).
Contribute as subject matter expert during Health Authorities inspections/audits and contribute to development, implementation of appropriate Corrective and Preventative Actions (CAPA). Act also as mentor/trainer.
Essential Requirements:
Graduate/Postgraduate/Doctorate degree in Life Sciences/Pharmacy/Medical Sciences or equivalent degree.
4 to 8 years of experience in drug safety/ development or closely related areas of responsibility, with a minimum of 3 years’ experience in safety /medical /scientific / regulatory writing.
Sound expertise in data analysis and presentation, strong project management and communication skills, paired with ability to lead global and cross-functional work groups.
Excellent understanding of drug development process, GCP and medical terminology.
Fluent English (oral and written).
Desiderable Requirements:
Preferably, at least 2 years of experience in safety writing.
You will 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
Other Spanish standard benefits are Company Pension Plan; Life and Accidental Insurance; Meals, Allowance or Canteen in the office; Flexible working hours.
Commitment to Diversity and Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
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.
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
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Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
