Regulatory Affairs Senior Data Steward (m/f/d)

​Professional | Permanent | Full-/ Part-time | Hybrid​

If you’re passionate about changing lives for the better, this is the opportunity you’ve been waiting for. In Research & Development , we’re continuously exploring innovative new treatment options to make a stronger, more positive impact on the lives of the patients we serve. You’ll work with talented colleagues in a state-of-the-art Research & Development environment, developing innovative medicines that change the life of patients for the better and help us make progress towards our vision of a world free of pain. Join us today, and discover the difference you can make.

What the job looks like
Each day you'll enjoy a variety of challenges, such as:

• Lead / support development, implementation and maintenance of data standards and data policies in GRA Digital Eco System
• Ensure alignment of implemented data standards with external requirements where applicable, such as ISO IDMP standards in the EU & US
• Lead / support implementation and maintenance of activities related to external structured data management requirements – xEVMPD, IDMP, SPOR, ESMP, etc.
• Ensure alignment of data standards with internal cross functional systems and processes within R&D (e.g. Development, Drug Safety) and outside R&D (such as Global Operations)
• Champion data management responsibilities for Global Regulatory Affairs Digital Eco System
• Oversee creation, update and maintenance of master data, reference data and critical transactional within RIMS and ensure conformance with defined standards
• Lead / support implementation and maintenance of data quality framework, data management KPIs, monitoring and reporting activities
• Lead / support delivery of data analytics and reporting requirements from RIMS & GRA Advanced Analytics capability
• Lead / Support data transfer strategy & execution related to M&A (transfer of data, documents, submissions)
• Collaborate closely with GRA Digital Product Champions, Process champions and IT teams to ensure complete alignment between data, process and technology

What you'll bring to the table
To make the most of this role and truly thrive, you should have:

• University degree in Life Sciences, Regulatory Affairs, Systems and Data Management, or Business Administration
• Expert level understanding and 10+ years working experience with Regulatory data management, data governance and data quality initiatives
• Deep expertise and 6+ years of experience with structured data submissions (IDMP, SPOR, xEVMPD)
• Strong understanding and working experience of regulatory data sources, interfaces with R&D, Global Operations and external systems
• Strong understanding and working experience with Veeva Vault RIM Suite (Registrations, Submissions, Submissions Archive, Publishing)
• Veeva certified professionals preferred
• Ability to manage multiple tasks simultaneously in a results-driven and customer-focused environment
• Excellent communication and presentation skills in English
• Attention to details, can do attitude and a positive and proactive mindset
• Excellent team collaboration skills, with the ability to work independently when required

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