Genpact BSc Life Science Submission Publisher Recruitment
Genpact BSc Life Science Submission Publisher Recruitment. MSc Life Science candidates apply. Interested and eligible candidates can check out all of the details regarding the same below:
Job: Lead Associate. Submission Publisher-LIF006988
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 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, and 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 the appropriate health agency gateway or media
- Archiving of the submission using the archiving tool
- Ensure documents provided in the submission content plan are correct through the 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 onboarded team members
- Tracking updates on new regulatory requirements 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.
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