Senior Data, Documents & Migration Stream Leader (H/F)
Servier
- Gif-sur-Yvette, Essonne
- CDI
- Temps-plein
As Work Stream Manager, you are a key driver of Worldwide Regulatory Affairs digital transformation. we are looking for a motivated, strategic, and competent professional to join our dynamic team and contribute to the successful implementation of the HRIM Program.Yours responsibilities :
- Lead the Work Streams, report the stream activities/deliveries to the Program Team and stakeholders,
- Manage Work Streams resources, schedules, and budgets
- Develop detailed project plans for the Work Streams, ensuring synchronization with other program components
- Supervise the collect, the cleaning and the metadata enrichment (IDMP) of regulatory data and documents constituting the Dossier. Ensure that all data and documents meet national and international regulatory standards
- Lead migration activities for systems such as Document Management System (eDMS), Regulatory Information Management (RIM), and Publishing. Coordinate the transition to modern solutions, in alignment with industry best practices
- Work closely with other Work Streams, Regulatory Affairs, Quality, Production, and other stakeholders to ensure integration and efficiency
- Master degree, PhD
- In-depth knowledge of pharmaceutical regulations and IDMP and xEVMPD standards.
- Proven experience in data and document management in the Regulatory Affairs end to end platform.
- Expertise in migrating systems including eDMS, RIM, and Publishing
- Employee empowerment, capacity to be agile, adaptable, and flexible, open mindedness.
- Excellent project management and strategic planning skills
- Ability to collaborate with cross-functional teams and coordinate efforts of multiple stakeholders
- Excellent communication and negotiation skills.
- Ability to make informed decisions in complex environments.
- Strong sense of organization and time management.
- Adaptability to change and ability to work under pressure.