Senior Manager, Regulatory Information Management
Category: Research & Development | Country: United Kingdom | City: Oxford | Type: Regular, Full Time | Job ID: 4249
Jazz Pharmaceuticals is an international biopharmaceutical company focused on improving patients’ lives by identifying, developing and commercializing meaningful products that address unmet medical needs. We are continuing to expand our commercial product portfolio and our research and development pipeline in therapeutic areas that can leverage our unique expertise.
Our therapeutic areas of focus include sleep and hematology/oncology – areas in which we have a deep understanding of the patient journey and a suite of products and product candidates to address critical needs.
We are looking for the best and brightest talent to join our team. If you’re looking to be a part of a company with an unwavering commitment to improving patients’ lives and being a great place to work, we hope you’ll explore our career openings and get to know Jazz Pharmaceuticals.
The Senior Manager, Regulatory Information Management (RIM), provides Global Regulatory Affairs leadership for Jazz’s new RIM system (JazzVault RIM). This position will work closely Global Regulatory Affairs, as well as other functions within R&D, and with IT, to manage training, documentation, user experience, and maintenance of the RIM system and acts as single point of contact for the broader Global Regulatory team and its use of the RIM system.
- Act as ambassador for JazzVault RIM across R&D, working to leverage optimal value for Jazz from the Veeva Vault RIM suite of products
- Manage communication regarding JazzVault RIM, including newsletters and maintaining and updating the intranet page for the system
- Create and maintain excellent relationships across GRA, R&D contributing groups, and IT, ensuring information management needs are met and requests for information are handled in a timely fashion;
- Serve as the Regulatory point of contact for R&D Records and Information Management activities and strategies
- Work closely with IT on schedules, document delivery, program risk, and mitigating strategies around use and version releases;
- Interfaces with system end-users to identify necessary ad hoc regulatory/compliance related system updates and resolves requests relevant to in-scope activities;
- Work closely with IT and vendor (Veeva) to support Veeva Vault RIM system updates and releases;
- In conjunction with IT, manage user accounts in JazzVault RIM including user permissions and security profiles;
- Manage Veeva Vault RIM configuration requests by working with IT, Veeva and functional GRA representatives;
- Support IT in validation testing as needed;
- Develops SOPs, Manuals, or other training materials for Veeva Vault RIM and works collaboratively with QA and Regulatory Affairs teams.
- Manages transition from live JazzVault RIM training to comprehensive, module-based eLearning provided through the JazzLearn interface.
- Minimum Requirements
- Bachelor’s degree
- Maintain Veeva Administrator’s Certificate
- Excellent communicator and team player who gets the job done – this is a hands-on position
- Minimum 3 years of Regulatory Affairs experienced required
- Strong understanding of Regulatory activities, projects, and processes
- Experience in Veeva Vault Regulatory Information Management software
- A working knowledge of Pharmaceutical/Biotech Regulatory Submission requirements as defined by ICH and Global Health Authority Guidelines (FDA, EMA, etc.)
- Ability to multitask effectively in a fast-paced environment with often shifting priorities
- Ability to work independently with minimal supervision or direction
- Excellent verbal and written communication skills
- Experience with extensive document archiving is required
- Experience managing vendors, contractors, and direct reports
Jazz Pharmaceuticals is an Equal Opportunity Employer.