Job Opportunity For BPharma Candidates at GENPACT – Apply Online. Bachelor’s degree in Pharmacy, life sciences, and business-related field candidates apply. Interested and eligible candidates can check out all of the details regarding the same below:
JOB TITLE: Lead Associate – Submission Publisher – LIF012813
Primary Location: India-Mumbai
Schedule: Full-time
Education Level: Bachelor’s / Graduation / Equivalent
Master Skills List: Operations
Job Category: Full Time
Genpact is inviting applications for the role of Lead Associate. Submission Publisher
The Submission Publisher manages all activities in publishing, dispatching and archiving of Global submissions (Renewals, Annual Report, PA Changes, dispatch and archival etc.) Job Opportunity For BPharma & Life science Candidates.
Responsibilities:
• Publishing of Annual Report for US FDA and Renewals for EMEA, APAC, and ROW etc.
• Publishing submissions using electronic publishing tools such as Liquent Insight Publisher and validating submissions using various validation tools
• Performing quality checks on the submissions and dispatching the submission via appropriate health agency gateway or media
• Archiving of the submission using archiving tool
• Ensure documents provided in submission content plan are correct through client’s electronic document management system
• Submission activity will include assembly creation, document verification, rendering, bookmark/ hyperlinking, compilation (as per Module
validation of submission as per country specific eCTD or NEES (where applicable) requirements
• Ensure adherence to the specific project specifications or standards throughout the lifecycle of the submission
• Should manage Publishing tasks- initiate, plan, execute, control and close assigned projects
• Conducting training for the new on-boarded team members
• Tracking updates on new regulatory requirement for publishing
• Prepare training documentation
Qualifications we seek in you!
• Bachelor’s degree in Pharmacy, life sciences or business-related field
• Profound experience in regulatory affairs, Pharmaceutical or Biotech industry, publishing and/ or document management
• Good computer skills, including Microsoft office suite (Word, PowerPoint and Excel), Adobe Acrobat, regulatory publishing software and document management systems
• Excellent communication and organizational skills
Possible Interview Questions for the role of Lead Associate – Submission Publisher at Genpact:
- Can you describe your experience in managing the submission publishing process in a regulatory environment?
Answer: “In my previous role as a Submission Publisher, I had the opportunity to manage the submission publishing process for regulatory submissions. I was responsible for ensuring the timely compilation, publishing, and delivery of regulatory submissions to health authorities. I worked closely with cross-functional teams, including regulatory affairs, clinical operations, and medical writing, to gather and review the required documents. I have experience in using electronic document management systems (EDMS) and publishing tools to compile, format, and publish submissions in compliance with regulatory guidelines.”
2. How do you ensure accuracy and quality in the submission publishing process?
Answer: “Accuracy and quality are crucial in the submission publishing process. I pay meticulous attention to detail and have a thorough review process in place. I ensure that all documents are properly formatted, that the hyperlinks and bookmarks are working correctly, and that the submission package meets the required standards. I also conduct quality checks to verify that the correct versions of documents are included, and I perform a final review before publishing. I actively collaborate with stakeholders to address any issues or discrepancies to maintain the highest level of accuracy and quality.”
3. How do you handle tight deadlines and manage multiple submissions simultaneously?
Answer: “Managing tight deadlines and multiple submissions is a common challenge in the regulatory publishing field. I am skilled at prioritizing tasks, setting realistic timelines, and coordinating with internal teams to ensure smooth workflow. I have experience in planning resources, utilizing project management tools, and providing regular updates to stakeholders to ensure everyone is aligned. I am flexible and adaptable, able to handle changing priorities and work efficiently under pressure to meet deadlines without compromising quality.”
- Can you describe your experience with regulatory guidelines and standards related to submission publishing?
Answer: “I am well-versed in regulatory guidelines and standards related to submission publishing, including eCTD (electronic Common Technical Document) specifications, ICH (International Council for Harmonisation) guidelines, and regional health authority requirements. I stay updated with the latest regulatory changes and attend training sessions and conferences to enhance my knowledge in this area. I have hands-on experience in applying these guidelines during the publishing process to ensure compliance and submission readiness.”
- How do you effectively communicate and collaborate with cross-functional teams during the submission publishing process?
Answer: “Collaboration and communication are essential in the submission publishing process. I maintain open and proactive communication with cross-functional teams to ensure a smooth and efficient workflow. I establish clear channels of communication, hold regular meetings to discuss timelines, and address any issues or challenges that may arise. I actively listen to the input and feedback from team members, providing guidance and support when needed. By fostering a collaborative environment, I promote effective teamwork and successful delivery of regulatory submissions.”
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