Merck is Hiring for Associate-Document Submission Support Role. All the Candidates who completed B.Sc/ M.Sc – Life Sciences are eligible. Interested Candidates can read the following Details and Apply for this role.
Job Description
- Company Name: Merck
- Job Role: Associate-Document Submission Support
- Qualification: B.Sc/ M.Sc – Life Sciences
- Location: Bangalore
- Batch: 2019/ 2020/ 2021/ 2022/ 2023
- Experience: Freshers
- Salary: Up to 4.5 LPA (Expected)
- Last Date: As Soon as Possible
Job Role & Responsibilities
- Report level publishing like CSR & DSUR.
- Formatting of documents for all disciplines contributing to Regulatory Dossiers and 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 routine and complex issues with minimal guidance.
- Assuring that submission documentation meets registration needs and timelines. Regular communication with the client, including face-to-face meetings, presentations, telephone, email, and conference call interaction.
- Prepare the submission readiness in VEEVA system.
Eligibility Criteria
- 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
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