Jazz Pharmaceuticals

Associate Director, Promotional Regulatory Affairs

US-PA-Philadelphia | US-CA-Palo Alto
4 weeks ago
Job ID
2017-3269
# of Openings
1
Category
Research & Development

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 Associate Director, Promotional Regulatory Affairs will be a member of Jazz Pharmaceuticals’ Global Regulatory Affairs Department and will be responsible for leading the promotional materials review process and providing insight, judgment and sound decisions on promotional programs and tactics for assigned products/teams under the guidance and direction of the Director/Senior Director, Promotional Regulatory Affairs.  Works collaboratively with medical, legal/compliance and commercial organizations and applies expertise and organizational influence to ensure development of promotional programs and tactics that are compliant with regulations and company policies while supporting the achievement of business objectives.

Specific responsibilities will include:

  • Lead the promotional material review committee (PMRC) for assigned products/teams in the US for Jazz Pharmaceuticals.   Provides input on decisions regarding concepts and draft promotional materials to satisfy the letter and spirit of FDA promotional regulations, corporate standards and policies and business objectives
    • Provide regulatory expertise, advice, and support to the organization.  Lead process and manage regulatory aspects of the review and approval for product promotional materials, maintain compliance of promotional materials with the governing FDA regulations, and submit promotional materials to the Office of Prescription Drug Promotion (OPDP) in a timely fashion.
    • Chair review meetings by leading discussion of the material being discussed and collaborating with other reviewers to determine next steps and approval status
    • Ensure that content, quality, accuracy, and format of submissions comply with applicable internal policies and procedures as well as FDA guidance and regulations
    • Effectively partner with Medical Affairs, Legal/Compliance, Marketing and other departments as needed to ensure the timely and efficient review of all materials
  • Provide regulatory support for Medical Affairs Review Committee (MARC) and publications review  
  • Assist in development of regulatory strategy, guidance and expertise on new marketing concepts and promotional tactics for assigned product(s). 
  • Helps manage interactions with FDA/OPDP for assigned product(s) including response to regulatory inquiries or enforcement actions, preparation of submissions for advisory comment and discussions with OPDP staff on requested changes as well as timely submission of materials for first use (FDA Form 2253 submission). 
  • Maintain a deep and current awareness of evolving FDA regulations and interpretations, FDA advisory comments, enforcement letters and policy issues affecting the pharmaceutical/biologics industry. Interprets and communicates FDA perspective to relevant stakeholders and recommends policy and/or procress changes as needed

Minimum Requirements:

  • B.S or B.A. degree in a scientific discipline or equivalent (a non-scientific degree with industry experience to compliment the degree) and a minimum of 7 years of increasingly responsible experience in the pharmaceutical industry, including at least 3 years of direct experience in advertising and promotional material review  
  • Deep and broad knowledge of FDA regulations and guidelines
  • Strong judgment and decision making skills
  • Excellent verbal and written communication skills

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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