Senior Associate Content Management
Merck Electronics
Work Your Magic with us!
Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That`s why we are always looking for curious minds that see themselves imagining the unimageable with us.
Your Role :
Ensure technical submission readiness of submission-relevant documents.
Format documents across all disciplines and products. •
Collaborate with stakeholders to ensure document readiness. •
Create and verify bookmarks and hyperlinks for submission compliance. •
Support stakeholders with literature requests, including ordering, formatting, uploading, and approval. •
Report level publishing for all safety reports, clinical safety management plans, periodic safety reports, pharmacovigilance reports and investigational medicinal product dossier (IMPD), nonclinical reports via suitable publishing tools. •
Serve as the point of contact for supporting all stakeholders in eDMS-related questions. •
Contribute as the subject matter expert (SME) for assigned projects and represent the team in cross-functional, global, and project-related discussions. •
Generate fresh ideas to improve the team's efficiency and set exemplary standards. •
Utilize the latest tools introduced and provide constructive feedback to improve the efficiency and quality of work. Strategic Impact Ensure readiness of submission relevant documents to support product registration and lifecycle management, business continuity, and compliance with market and health authority requirements world-wide.
Collaborating across R&D functions to support basic to intermediate tasks under guidance from Submission Readiness experts. Cooperation •
Internally: International Regulatory Affairs (Regional Hubs), Regulatory CMC, Regulatory Lead (incl. US- and EU-Lead), Regulatory Project Manager, Global Patient Safety, Medical Writing, other RQS functions, Global Development Operations, R&D IT, Clinical functions, Non-clinical functions.
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