Associate-document Submission Support

2 weeks ago

Bengaluru, India Merck KGaA Darmstadt Germany Full time

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.

**Associate - Document Submission Support**

**Roles and Responsibilities**:

- Report level publishing like CSR & DSUR
- Formatting of documents for all disciplines contributing to Regulatory Dossiersand all products acc to SOP Technical Submission Readiness of Submission Relevant Documents.
- Creating and updating Virtual Documents.Creating and verifying bookmark structure and hyperlinks to ensure submission-readiness of submission relevant documents.
- Supporting stakeholders with required literature via ordering at Scientific Library, formatting, uploading, approving.
- Report publishing for all safety reports, clinical safety management plans as well as nonclinical reports via publishing tool.
- Point of contact for supporting all stakeholders in eDMS related questions.Running reports in RIMS for PSMF, changing them from excel to pdf.
- Being able to independently resolve routineand complex issues with mínimal guidance.
- Prepare the submission readiness in VEEVA system

**Qualifications**:

- Degree in a Life Science or related discipline.
- Understanding of the Regulatory Operations area, including process and technology
- Excellent spoken and written English.
- Ability to handle software and databases needed to support the regulatory function according to the role.
- Excellent knowledge of Microsoft Office
- Excellent knowledge of electronic Document Management Systems
- Ability to work in teams and positively influence team spirit
- Result orientation and willingness to take ownership
- Strong customer orientation
- Strong communication skills

**What we offer**:We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress

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