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Senior Manager, Promotional Regulatory Affairs

Company: Jazz Pharmaceuticals
Location: Philadelphia
Posted on: February 16, 2020

Job Description:

OVERVIEW

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.

POSITION PROFILE

The Senior Manager, Promotional Regulatory Affairs will be a member of Jazz Pharmaceuticals Regulatory Affairs Department and will be a member of the Global Promotional Regulatory Affairs Leadership Team. The senior manager, Promotional Regulatory Affairs will manage a global team of Promotional Materials Review Committee (PMRC) Project Managers responsible for coordinating the review and approval of items submitted to the Committee. The candidate will manage the relationship with the electronic routing system vendor and will be responsible for the appropriate use of the system within Jazz. The candidate will help implement process improvement changes to increase the efficiency and effectiveness of the promotional material review process. This position reports directly to the Global Head of Promotional Regulatory Affairs and is a key contributor to the success of the PMRC operation.

SPECIFIC RESPONSIBILITIES WILL INCLUDE:

* Lead the global team of PMRC project managers: provide direct line management activities for the global PMRC Project Manager team and ensure appropriate resource allocation.

* As a member of the Promotional Regulatory Leadership Team, share improvement updates and status of the electronic routing system and ensure that the Review and Approval Process is optimally set up to support the business needs

* Oversee the onboarding and continuous training of PMRC project managers

* Working with our external vendor (Veeva), is responsible for the optimal operation of the electronic routing system

* Maintain, oversee updates of the electronic routing system, and communicates those updates to all users

* Partner with cross functional team leaders for the optimal utilization of the PMRC process

* As needed, help the PMRC Project Manager in their essential functions:

* Schedule, finalize the agenda for and attend the promotional material review meetings for assigned project(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

REQUIRED KNOWLEDGE, SKILLS, AND ABILITIES

* Ability to lead a global team effectively

* Have a problem-solving mind-set and able to solve a broad range of problems in varying scope and complexity

* Can employ essential project management tools and methodologies to facilitate team activity and ensure execution of the team functions

* Extreme attention to detail with an ability to detect and correct errors/inconsistencies in various types of documents and systems

* 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 a matrix team and a functional team

REQUIRED/PREFERRED EDUCATION AND LICENSES

* B.S./B.A. with a minimum of 5 years of experience in the pharmaceutical or biotech industry

* Experience associated with advertising and promotion regulations required

* Experience managing or leading a team or individual preferred

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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Keywords: Jazz Pharmaceuticals, Philadelphia , Senior Manager, Promotional Regulatory Affairs, Executive , Philadelphia, Pennsylvania

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