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Senior Manager, Veeva RIM- Global Lead of Change, Communication and Training (all genders)
A career at our company is an ongoing journey of discovery: our 58,000 people are shaping how the world lives, works and plays through next generation advancements in Healthcare, Life Science and Electronics. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others.
United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.
We have an exciting new role within our Global Reg Affairs Operations organization. This role in Regulatory Compliance & Regulatory Information Management acts as part of the Veeva RIM Leaders Team (Tiger team) and collaborates very closely with the various leads (process, data and system leads) and the head of the Veeva Center of Excellence. While exchanging, engaging, and presenting to large and diverse user communities across the globe you interact with members from multiple functions on a broad span of levels and roles. Your ability to lead large, diverse changes across R&D and beyond with high or even unique complexity is key to perform this role. You filter, prioritize, analyze and validate complex and multifaceted information from a diverse range of external and internal sources, which requires in-depth understanding of how sub-functions or even functions work together. You are responsible and accountable for the communication and training strategy of Breeze related changes. Change management, training and communication from strategy to execution on process, data and system changes round off the portfolio. By influencing others internally and externally, including senior leaders or even key decision makers this may lead to negotiations with significant business impact that are likely to involve internal and external parties. The role designs, prepares, consolidates thus paving the way for multi-channel communication and training pathways.
Who you are:
- Excellent interpersonal skills and talent for organizational savvy
- 5+ years’ experience in the pharma industry
- Excellent understanding of global regulatory processes (submissions, registrations, publishing) across the drug life cycle from CTA/IND, over MAA/NDA/BLA towards marketed license management and maintenance
- Understanding of regulatory affairs interdependencies and cross-functional dependencies (Clinical Development, Drug Safety and Pharmacovigilance, CMC, Manufacturing, Quality, AdPromo, Medical Affairs, Commercial etc.)
- Working experience as regulatory product expert or strategist on marketed products and on marketed license management preferable
- High affinity for most current technologies
- Consistent track record in effectively using RIM systems (ideally Veeva Vault RIM)
- Very good understanding of regulatory data and information management
- Experience and knowledge on Change Management strategies to drive the change within the organization and support stakeholders
- Focus driven strategic thinker, collaborative and pragmatic
- Knowledgeable about change and communication tools to drive and coordinate the change related to Veeva Vault RIM
- Working in a matrix structure
- Able to navigate strategy towards execution
- Training oversight, training changes and improvements
- Able to oversee and manage the Veeva RIM Vault EVA Room content
- Out of the box and behind horizon thinking skills are essential
What we offer: With us, there are always opportunities to break new ground. We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!
Curious? Apply and find more information at https://jobs.vibrantm.com