Manager Promotional Regulatory Affairs
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 will be a member of Jazz Pharmaceuticals’ Regulatory Affairs Department and will be responsible for coordinating the review and approval of items submitted to the Promotional Materials Review Committee (PMRC) for assigned products/teams. Under the direction of the Regulatory Chair for assigned teams, this position works collaboratively with medical, legal, compliance, and commercial organizations to ensure development of promotional programs and tactics that are compliant with regulations and company policies while providing on-going training and support for 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 promotional material review process.
Essential Job Functions:
Job Responsibilities and Requirements:
The Manager, Promotional Regulatory Affairs will:
- Coordinate, 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
- Take notes at review meetings 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 as well as FDA/OPDP guidance and regulations
- Work closely with Marketing to ensure that final pieces are consistent with the review committee’s recommendations
- Ensure, when required, committee approved materials are submitted to FDA for advisory comment (under Subpart H or otherwise) and/or at time of first use under Form FDA 2253.
PROVIDE ON-GOING TRAINING AND SUPPORT
- Organize, plan, and develop regularly scheduled training and best practices
- B.S/B.A. (or equivalent in years of industry related experience) with a minimum of three to 5 years of experience in the pharmaceutical or biotech industry
- Experience associated with advertising and promotion regulations as well as a high proficiency with the use of an electronic approval system is strongly desired
- Able to provide instruction, training, and guidance to support the promotional review process
- 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
Some travel 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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Job posted: 2021-02-01