Genpact Jobs For Life Sciences Candidates – BSc Apply Now

Genpact Jobs For Life Sciences Candidates – BSc Apply Now

Genpact Jobs For Life Sciences Candidates – BSc Apply Now. BSc Life Sciences Lead Associate-Submission Publisher job opening at Genpact. Genpact Bengaluru BSc Life Sciences Job. Interested and eligible applicants can check out all of the details on the same below

Possible Interview Questions May be asked for Lead Associate-Submission Publisher at Genpact are posted below

Lead Associate-Submission Publisher-HEA009275

Primary Location: India-Mumbai

Schedule: Full-time

Education: Level Bachelor’s / Graduation / Equivalent

Job Posting: Jul 5, 2023, 10:23:09 PM

Un posting: Date Ongoing

Master Skills: List Operations

Job Category: Full Time

Job Description for Lead Associate-Submission Publisher at Genpact:

With a startup spirit and 115,000+ curious and courageous minds, we have the expertise to go deep with the world’s biggest brands—and we have fun doing it. We dream in digital, dare in reality, and reinvent the ways companies work to make an impact far bigger than just our bottom line. We’re harnessing the power of technology and humanity to create meaningful transformation that moves us forward in our pursuit of a world that works better for people. Now, we’re calling upon the thinkers and

doers, those with a natural curiosity and a hunger to keep learning, keep growing. People who thrive on fearlessly experimenting, seizing opportunities, and pushing boundaries to turn our vision into reality. And as you help us create a better world, we will help you build your own intellectual firepower. Welcome to the relentless pursuit of better.

We are 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.)

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 1-5 in CTD format), publishing; and
  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

Genpact is an Equal Opportunity Employer and considers applicants for all positions without regard to race, color, religion or belief, sex, age, national origin, citizenship status, marital status, military/veteran status, genetic information, sexual orientation, gender identity, physical or mental disability or any other characteristic protected by applicable laws. Genpact is committed to creating a dynamic work environment that values diversity and inclusion, respect and integrity, customer focus, and innovation. For more information, visit www.genpact.com. Follow us on Twitter, Facebook, LinkedIn, and YouTube.

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Possible Interview Questions May be asked for Lead Associate-Submission Publisher at Genpact

1. Can you explain your experience in submission publishing and your familiarity with regulatory guidelines and requirements? Answer: In my previous role as a Submission Publisher, I have gained extensive experience in the preparation and publishing of regulatory submissions. I am well-versed in regulatory guidelines such as eCTD, CTD, and regional submission requirements. I have successfully compiled and submitted various types of regulatory documents, including INDs, NDAs, and post-approval submissions. I am proficient in using electronic publishing tools and have a solid understanding of validation processes, document formatting, and publishing standards.

2. How do you ensure accuracy and compliance in submission publishing, considering the strict timelines and regulatory requirements? Answer: Accuracy and compliance are of utmost importance in submission publishing. To ensure this, I meticulously review and verify all documents and data before publishing. I adhere to established quality control processes and conduct thorough checks for formatting, consistency, and completeness. I closely follow regulatory guidelines and submission requirements to ensure compliance with specific agency standards. I also maintain effective communication with cross-functional teams to obtain necessary approvals and resolve any potential issues promptly.

3. Can you describe a situation where you had to manage multiple projects simultaneously and meet tight deadlines? How did you prioritize and ensure successful completion? Answer: In my previous role, I often had to handle multiple projects simultaneously, each with its own set of deadlines. To effectively manage these projects, I created a detailed project plan, identifying key milestones and deliverables for each submission. I prioritized tasks based on regulatory requirements, urgency, and interdependencies. I communicated with stakeholders to set realistic expectations and ensured that resources were allocated appropriately. Additionally, I proactively monitored progress, identified potential bottlenecks, and took necessary measures to keep projects on track, ultimately meeting all deadlines successfully.

4. How do you handle unexpected challenges or changes in regulatory requirements during the submission process? Answer: Unexpected challenges and changes are not uncommon in the regulatory landscape. When faced with such situations, I remain adaptable and proactive. I closely monitor regulatory updates and promptly assess the impact on ongoing submissions. I collaborate with cross-functional teams, including regulatory affairs and quality assurance, to develop appropriate strategies and ensure compliance with the new requirements. I communicate effectively with stakeholders, including regulatory authorities, to address any concerns and resolve issues promptly. Flexibility, attention to detail, and effective problem-solving skills are key in navigating these challenges.

5. Can you provide an example of a successful collaboration with cross-functional teams to ensure timely submission of regulatory documents? Answer: In a recent project, I worked closely with a cross-functional team consisting of regulatory affairs, clinical operations, and medical writing to prepare and submit a New Drug Application (NDA). Through effective collaboration, we established a clear timeline, allocated responsibilities, and conducted regular meetings to track progress. I provided guidance on submission requirements and document formatting, ensuring that all components were prepared in accordance with regulatory guidelines. By maintaining open communication and addressing challenges proactively, we successfully completed the submission ahead of the deadline, leading to regulatory approval.

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