Senior Data, Documents & Migration Stream Leader (H/F)
www.servier.com
The Work Streams leader’s position is a central part of the Holistic Regulatory Information Management HRIM) Program. Under the Program Director’s direction, you lead the Work Streams dedicated to the Regulatory data, documents, and migration of the data and the documents. You will work closely with other Work Stream leads, experts, and key business users to ensure the success of the initiative.
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
Your profile :
- 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.
Quel que soit votre domaine d'expertise, votre travail au sein du Groupe Servier contribue à faire avancer le progrès thérapeutique au bénéfice des patients. Vous ferez partie d'équipes reconnues pour leur excellence scientifique et développerez votre plein potentiel dans un environnement professionnel qui vous encourage à vous développer. Des parcours d'intégration sur mesure, des opportunités de mobilité, des formations de qualité, un management responsable, un esprit d'équipe... Tout cela et plus encore dans un lieu de travail axé sur votre bien-être.
Chez Servier, nous sommes engagés dans le progrès thérapeutique au service des besoins des patients. Nous mettons la diversité de nos collaborateurs comme une source de richesse pour l'accomplissement de cette vocation.