Genpact BSc Associate Job Opening For Life Sciences, Apply Online
Genpact BSc Associate Job Opening For Life Sciences, Apply Online. BSc Life Sciences candidates apply. Interested and eligible candidates can check out all of the details regarding the same below:
Possible Interview Questions for the Role of Lead Associate. Submission Publisher-LIF012813 at Genpact are posted below
Job: 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
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.
Possible Interview Questions for the Role of Lead Associate. Submission Publisher-LIF012813 at Genpact:
- Can you explain your experience in regulatory affairs and how it relates to the role of Lead Associate Submission Publisher? Answer: I have a strong background in regulatory affairs, specifically in the pharmaceutical and biotech industry. I have experience in managing submissions, publishing documents, and ensuring compliance with regulatory requirements. I am familiar with electronic publishing tools such as Liquent Insight Publisher and validation tools. My experience also includes performing quality checks, dispatching submissions, and archiving documents. I have a good understanding of submission formats like CTD and country-specific requirements.
- How do you ensure the accuracy and quality of submissions when using electronic publishing tools and validation tools? Answer: When using electronic publishing tools and validation tools, I follow a meticulous process to ensure accuracy and quality. First, I review the submission content plan to ensure that all documents are correct and in the proper format. Then, I use the electronic document management system to verify the documents and perform any necessary rendering, bookmarking, and hyperlinking. I also compile the submission according to the specific requirements, such as Module 1-5 in CTD format. Before dispatching the submission, I conduct thorough quality checks using validation tools to identify any errors or inconsistencies.
- How do you stay updated on new regulatory requirements for publishing and ensure compliance? Answer: Staying updated on new regulatory requirements is essential in the field of publishing. I actively track and monitor regulatory updates through reliable sources such as health agency websites, industry publications, and regulatory forums. I also engage in continuous learning and professional development activities, such as attending regulatory conferences and training programs. Additionally, I maintain a network of regulatory professionals and participate in knowledge-sharing sessions to stay informed about changes in regulations. By proactively staying informed, I ensure compliance with the latest requirements.
- Can you describe your experience in project management and how you would apply it to managing publishing tasks? Answer: I have experience in project management and have successfully managed multiple publishing projects throughout my career. When managing publishing tasks, I follow a structured approach. I initiate the project by defining the scope, objectives, and timelines. I plan and allocate resources, ensuring that all necessary tools and technologies are available. During execution, I closely monitor the progress, address any issues or roadblocks, and maintain effective communication with stakeholders. I exercise control by regularly reviewing the project status, ensuring adherence to specifications and standards. Finally, I close the project by conducting a comprehensive review and capturing lessons learned for future improvements.
- How do you handle training and onboarding of new team members in the publishing domain? Answer: Training and onboarding new team members in the publishing domain are crucial for their successful integration into the team. I start by understanding their existing knowledge and experience levels. I then design a comprehensive training plan that covers the fundamentals of publishing, including tools, processes, and best practices. I provide hands-on training, allowing them to practice using publishing software and tools. Additionally, I ensure that they have access to relevant documentation and resources. Throughout the training process, I maintain open communication channels, encourage questions, and provide ongoing support and feedback. I also monitor their progress and offer additional guidance as needed to ensure their proficiency in the role.
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