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Associate Director, Promotional Regulatory Affairs

Company: Jazz Pharma
Location: Palo Alto
Posted on: February 16, 2021

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. Responsibilities: 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.Essential Job Functions:Specific responsibilities will include:Specific responsibilities will include: Lead the promotional material review committee (PMRC) for assigned products/therapeutic areas in the US for Jazz Pharmaceuticals. Under the direction of the US lead Promotional Regulatory Affairs, 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 Serve as the Promotional Regulatory Affairs lead for a new product launch through contributions to the US Core launch team for assigned product(s)o Provide regulatory advice, and support to the organization. Lead the PMRC 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.o Further develop independent leadership skills and regulatory subject matter expertiseo Chair review meetings by leading discussion of the material being discussed and collaborating with other cross-functional reviewers to determine next steps and approval statuso Ensure that content, quality, accuracy, and format of submissions comply with applicable internal policies and procedures as well as FDA guidance and regulationso Effectively partner with Regulatory colleagues, Medical Affairs, Legal/Compliance, Marketing and other departments as needed to ensure the thorough, timely and efficient review of all materialso Work closely with the US Lead Promotional Regulatory Affairs and other team members to develop regulatory subject matter expertise and leadership skills Provide regulatory support for Medical Affairs Review Committee (MARC) and publications review Contribute to the development of regulatory strategy through assigned Global Regulatory team Provide guidance and expertise on new marketing concepts and promotional tactics for assigned product(s). Lead interactions with FDA/OPDP for assigned product(s) including submission of materials for advisory comments for full approval and accelerated approval products. Further develop depth 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 process changes as needed, consulting with Regulatory colleagues as appropriateRequired/Preferred Education and LicensesB.S or B.A. degree in a scientific discipline or equivalent (a non-scientific degree with industry experience to compliment the degree). Advanced degree in a scientific discipline (e.g. PharmD) strongly preferred. A minimum of 3 to 5 years of increasingly responsible experience in the pharmaceutical industry; direct experience in advertising and promotional material review (Regulatory or otherwise) is required Experience with new product launch support is strongly preferred Strong understanding of FDA regulations and guidelines Strong judgment and decision making skills Excellent collaboration, 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.

Keywords: Jazz Pharma, Palo Alto , Associate Director, Promotional Regulatory Affairs, Executive , Palo Alto, California

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