Sommario
About the Role
Major accountabilities
- Develop plans to address identified functional learning opportunities / needs necessary to enhance the team's knowledge and skills in regulatory affairs.
- Partner with stakeholders to develop effective process and compliance trainings to support organizational readiness of processes and associated systems and technology.
- Drive the E2E training preparation (i.e. concept, strategy, design, tools) and roll-out (i.e. communication, relevant training systems) for new system implementation and selected policy / Reg Intel related initiatives ensuring that the RA user community is prepared for the implementation and uptake of new or enhanced tools and legal requirements in support of their business activities
- Oversight on cross functional training and Knowledge Management (KM) initiatives and opportunities.
- In alignment with respective Regulatory Affairs team lead(s), and in collaboration with Global Development University / Novartis Learning Institute, develop and implement a lean learning concept with role specific, right-sized, and right-tied learning.
- Liaise with other groups as applicable to leverage common training approaches, tools and techniques to ensure that employees have access to the necessary resources and opportunities to enhance their skills, knowledge, and competencies
- Ensure that training programs are fit-for-purpose and aligned with industry best practices and regulatory requirements.
- Develop and maintain RA basis “universal” on-boarding package and support RA hiring managers with development of material to support target on-boarding of new joiners and post-graduate as needed
- Represent RA in Divisional Training Governance and Forums or equivalent.
- Establish metrics and evaluation methods to assess the effectiveness of capability enhancement initiatives. Regularly monitor and report on the progress and impact of training programs.
Experience and skills
- Life Science Degree or other University degree with equivalent experience
- Must have strong communication skills Regulatory and Drug development experience
- Strong knowledge on E2E process, supporting system, regulations and business change(s).
- Proven successful experience on the design and development of training concepts with cross-functional teams
- Organizational awareness, including significant experience working cross-functionally
- Proven ability to influence change and act as change advocate
- Experience in Project management tools & systems
- Technology-savvy – ability to leverage and use systems, technology and automation to (including digital assistants and AI tools) to derive impactful trainings and communications
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.
