Genpact Pharma Publishing Jobs – Apply Online
Job Description – Lead Associate. Submission Publisher (LIF012812)
Lead Associate. Submission Publisher-LIF012812
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
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
Job – Lead Associate
Primary Location – India-Mumbai
Schedule – Full-time
Education Level – Bachelor’s / Graduation / Equivalent
Master Skills List – Operations
Job Category – Full Time
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