, Pennsylvania

Job Description

Business Requirements
1. Understand the fundamentals of CMC and Labeling content of eCTD submissions
2. Understand registration, application/submission and publishing process of regulatory submissions

Core Competency
1. Lead Change Control process of the tool
2. Tool Issue Resolution
3. Troubleshooting User Issues
4. Responsible for Business Continuity Planning / Disaster Recovery Procedure
5. Responsible for System Downtime Management Procedure
6. Presenting Data Monitoring and Communications (Adoption Metrics) to Business Teams
7. Responsible for Hypercare Support
8. Liaise with different IT Teams (Application Dev, ETL, Project Core) to prepare for what will be coming into Operations
9. Support Tool Business Processes
10. QA – Ensuring processes are followed as designed
11. Onboard / Train new Application Team members
12. Alignment with HRM, Submission content Authoring, Submission archival for future releases and UAT testing that is needed
13. Supporting Managing Community of Practice
14. First line support for Tool Issue Resolution
15. Gathering Data and assisting with preparing Communications (Adoption Metrics)
16. Hypercare Support
17. Liaise with IT Team and Application Dev team to prepare for what will be coming into Operations
18. Draft Job Aids/Procedures from hyper care and dev feedback
19. Review UAT scripts and provide feedback on accuracy per tool
20. JIRA Mock-up and stories

Nice to have
1. Parexel Insight HRM/Publishing experience
2. OpenText LSDR experience
The Company is an equal opportunity employer and makes employment decisions on the basis of merit and business needs. The Company will consider all qualified applicants for employment without regard to race, color, religious creed, citizenship, national origin, ancestry, age, sex, sexual orientation, genetic information, physical or mental disability, veteran or marital status, or any other class protected by law. To comply with applicable laws ensuring equal employment opportunities to qualified individuals with a disability, the Company will make reasonable accommodations for the known physical or mental limitations of an otherwise qualified individual with a disability who is an applicant or an employee unless undue hardship to the Company would result.

, Pennsylvania

Careers at NTT DATA

Innovation is at the heart of what we do. Innovation that makes an impact and improves business performance. Innovation that improves our clients’ bottom line.

We are always on the lookout for talented innovators to join us - especially for people who can use their creativity to drive value for our clients worldwide. Discover more career opportunities that can help you make the most of your skills.


We are one of the largest global IT services company with operations in more than 40 countries. We offer an advanced portfolio of application, business process, cloud, and infrastructure services to businesses and governments worldwide.

Our roots cross continents and cultures, dating back five decades. We’ve grown organically and decisively by acquiring some of the best IT services providers across the globe. This pedigree yields a characteristic special to NTT DATA: the opportunity of a global brand with the creative energy of a start-up.

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