Senior Associate of 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 Senior Associate 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 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 promotional material review process.
Schedule, finalize the agenda for and attend all promotional material review meetings for assigned team(s) Ensure comments obtained from review disciplines are captured in the electronic review and approval system and 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
Work closely with marketing to ensure that final pieces are consistent with the review committee’s recommendations
Working in conjunction with the regulatory lead, prepare both draft materials for Submission for Advisory Comment to FDA when required and submission of final materials on form FDA 2253
Required Knowledge, Skills, and Abilities
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
B.S./B.A. (or equivalent in years of industry related experience)with a minimum of one to 3 years of experience in the pharmaceutical or biotech industry
Experience in the pharmaceutical or biotech industry, specifically with advertising and promotion regulations, is strongly desired
Description of Physical Demands
Occasional mobility within office environment. Routinely sitting for extended periods of time.
Constantly operating a computer, printer, telephone and other similar office machinery.
Description of Work Environment
Work indoors in normal office environment with little exposure to excessive noise, dust, fumes, vibrations and temperature changes.
Frequent computer use at workstation.
May move from one work location to another occasionally.
Responsibilities may require a work schedule that may include working outside of “normal” work hours, in order to meet business demands.
Occasional public contact requiring appropriate business apparel. Some travel required (10-20%)
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.