Manager, Promotional Regulatory Affairs
Category: Research & Development| Country: United Kingdom | City: Oxford | Type: Regular, Full Time | Job ID: 4323
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 Manager of Promotional Regulatory Affairs (PRA) will be a member of Jazz Pharmaceuticals’ Regulatory Affairs Department and will be responsible for coordinating the review and approval of items through the materials review process for assigned products/teams. In collaboration with the PRA lead for assigned teams, this position works with medical, legal, compliance, and commercial organizations to ensure development of promotional and non-promotional programs and tactics that are compliant with regulations and company policies while supporting the achievement of business objectives. As needed, the candidate will also help to implement process improvement changes to increase the efficiency and effectiveness of the material review process.
The Manager, Promotional Regulatory Affairs will:
- Schedule, finalize the agenda for, and attend all review meetings
- Ensure comments obtained from review disciplines are captured in the electronic review and approval system, consolidated and communicated
- Capture notes during live review meetings and review comments provided in offline review to ensure reviewer comments are appropriately reconciled and next steps are clearly communicated
- Track the review and evaluation of materials submitted and ensure approval status is documented for each reviewer prior to communicating finalization of the review process
- Ensure that content, quality, accuracy, and format of submissions comply with applicable internal policies and procedures
- Work closely with Marketing and Medical Affairs to ensure that final pieces are consistent with the reviewer’s recommendations
- Responsible for electronic approval system (EAS) training (internal and external agencies) and process
- Administrator of the EAS system for EU/RoW
- Liaise with marketing and medical teams and their agencies to address system/process questions, etc.
Required Knowledge, Skills, and Abilities
- Bachelor’s Degree with a minimum of three years of experience in the pharmaceutical or biotech industry required
- Experience associated with advertising and promotion regulations strongly desired
- Extreme attention to detail with an ability to detect and correct errors/inconsistencies in various types of documents
- Excellent verbal and written communication skills
- Must be able to work successfully within a team/partnership environment and as an individual contributor, with a high level of professionalism
- Ability to interact effectively with all levels/roles of project team members
Required/Preferred Education and Licenses
- Prior experience managing a review process using an electronic approval system (e.g. Veeva)
Jazz Pharmaceuticals is an Equal Opportunity Employer.