Overview
Regulatory Affairs Senior Data Steward (m/f/d)
Join to apply for the Regulatory Affairs Senior Data Steward (m/f/d) role at Grünenthal Group.
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.
What The Job Looks Like
* 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
* 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
Seniority level
* Associate
Employment type
* Full-time
Job function
* Research, Science, and Health Care Provider
Industries
* Pharmaceutical Manufacturing, Hospitals and Health Care, and Biotechnology Research
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