Merck Associate – Document Submission Support Role For Life Sciences, Apply Online
Merck Associate – Document Submission Support Role For Life Sciences, Apply Online. Merck Life Sciences jobs. Associate-Document Submission Support job opening for life sciences candidates. Interested and eligible applicants can check out all of the details on the same below
Possible Interview Questions for the Technical Round are posted below
Associate-Document Submission Support
Posted 11 Jul 2023
Location: Bangalore, Karnataka – India
Req Id: 259785
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 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
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!
Apply now and become a part of our diverse team!
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Possible Interview Questions for the Technical Round:
- Can you describe your experience in document submission support for regulatory dossiers? How have you ensured the submission readiness of relevant documents and met registration needs and timelines?
- Answer: In my previous role, I have worked extensively in document submission support for regulatory dossiers. I have been responsible for formatting and publishing reports like CSR & DSUR, ensuring proper bookmark structure and hyperlinks, and verifying submission readiness. To meet registration needs and timelines, I have closely followed standard operating procedures (SOPs) and maintained regular communication with clients. Additionally, I have utilized my knowledge of electronic Document Management Systems and software like VEEVA to prepare submission readiness.
- How do you handle complex issues related to eDMS (electronic Document Management Systems) and regulatory operations? Can you provide an example of a complex issue you resolved independently?
- Answer: When encountering complex issues related to eDMS and regulatory operations, I approach them systematically by gathering all relevant information and analyzing the situation. By leveraging my technical expertise and problem-solving skills, I strive to identify root causes and explore possible solutions. One example of a complex issue I resolved independently was a document version control problem within the eDMS. Through meticulous investigation, I discovered the source of the issue and implemented corrective measures, ensuring document integrity and compliance.
- How do you ensure the accuracy and quality of documents during the publishing and formatting process? Can you discuss any specific measures or tools you have used in the past?
- Answer: Accuracy and quality are paramount during the publishing and formatting process. To ensure this, I have developed a meticulous approach, double-checking every detail, and adhering to established formatting guidelines. I have utilized tools like Microsoft Office, particularly Word, to create consistent formatting and layouts. Additionally, I have employed quality control measures such as thorough proofreading, cross-referencing with source documents, and conducting document reviews with stakeholders to ensure accuracy and alignment with regulatory requirements.
- How do you effectively collaborate with stakeholders, both internally and externally, in a document submission support role? Can you provide an example of a situation where your strong communication skills positively influenced team spirit?
- Answer: Effective collaboration with stakeholders is crucial in a document submission support role. I prioritize open and clear communication to foster strong working relationships. For instance, in a previous project, I worked closely with a team of cross-functional experts and external clients to prepare regulatory submission documents. By maintaining regular communication channels, actively listening to their needs, and providing timely updates and assistance, I helped foster a collaborative and supportive environment. This positive team spirit enabled us to meet deadlines and deliver high-quality submission documents.
- How do you stay updated with the evolving regulations and technologies in the field of regulatory operations? Can you share any strategies or resources you use to enhance your knowledge in this area?
- Answer: Staying updated with evolving regulations and technologies is essential in the field of regulatory operations. To enhance my knowledge, I regularly engage in professional development activities such as attending industry conferences, participating in webinars, and subscribing to regulatory newsletters and publications. Additionally, I actively seek opportunities to network with peers in the regulatory field, both online and through professional associations. These strategies allow me to stay informed about the latest trends, best practices, and regulatory updates, enabling me to adapt and excel in my role.
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