Senior Manager, Regulatory Information Management (Remote), Oxford
Location:
Oxford, United Kingdom
Job Category:
Customer Service
EU work permit required:
Yes
Job Reference:
0edf41a6dc17
Job Description:
Brief Description:
The Senior Manager, Regulatory Information Management (RIM), will work closely with R&D and Manufacturing as well as other functions within Jazz, to manage training, documentation, user experience, and maintenance of the RIM system and integration with the other systems at Jazz.
Essential Functions:
1. Understand the business processes (across R&D and Manufacturing), regulatory and reporting requirements and converting these into RIM configuration ideas/proposals.
2. Configure RIM (Sandbox, Validation, and Production environments) as per the agreed proposals.
3. Work with other Business and System Leads across Jazz to ensure alignment of data, system configurations and user experience.
4. User requirement gathering and creation of end user reports.
5. Triage support requests from users across GRA and Manufacturing.
6. Develop and deliver data and document migration strategies.
7. Manage RIM user accounts (in conjunction with IT), including user permissions and security profiles.
8. Create and deliver RIM training material specific to different levels of knowledge and experience of individuals across R&D and Manufacturing.
9. Knowledge of other systems outside of RIM, such as Publishing.
Required Knowledge, Skills, and Abilities:
1. Education with a minimum of 5 years of pharmaceutical/Regulatory Affairs experience.
2. Veeva White Belt certified.
3. Knowledge of US/EU/International Regulatory Requirements.
4. Ability to manage timely delivery of projects and/or programs.
5. Exceptional written and verbal communication skills.
Required Education and Licenses:
Bachelor's Degree in Business or Life Sciences is required.
Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law.
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