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Lead Associate. Submission Publisher

With a startup spirit and 90,000+ curious and courageous minds, we have the expertise to go deep with the world’s biggest brands—and we have fun doing it. Now, we’re calling all you rule-breakers and risk-takers who see the world differently and are bold enough to reinvent it. Come, transform with us.
Are you the one we are looking for?
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.

Job: Lead Associate

Job ID: LIF006988

Primary Location: India - Mumbai

Education Level: Bachelor's / Graduation / Equivalent

Job Posting: Mar 3, 2022

Master Skills List: Operations

Job Category: Full Time