Director Promotional Regulatory Affairs
Company: Jazz Pharma
Location: Palo Alto
Posted on: April 10, 2021
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Job Description:
Overview:
Jazz Pharmaceuticals is a global biopharmaceutical company
dedicated to developing life-changing medicines for people with
serious diseases - often with limited or no options. We have a
diverse portfolio of marketed medicines and novel product
candidates, from early- to late-stage development, in key
therapeutic areas. Our focus is in neuroscience, including sleep
medicine and movement disorders, and in oncology, including
hematologic and solid tumors. We actively explore new options for
patients including novel compounds, small molecule advancements,
biologics and innovative delivery technologies. Jazz is
headquartered in Dublin, Ireland and has employees around the
globe, serving patients in more than 90 countries.
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 Director, Promotional Regulatory Affairs (PRA) will be a member
of Jazz Pharmaceuticals' Global Medical 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 Senior Director, Promotional Regulatory
Affairs. Will provide senior PRA leadership to 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:
Provide PRA leadership at the business unit level with the
potential to manage/mentor direct report(s)
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(es) 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 expertise
o Chair review meetings by leading discussion of the material being
discussed and collaborating with other cross-functional reviewers
to determine next steps and approval status
o Ensure that content, quality, accuracy, and format of submissions
comply with applicable internal policies and procedures as well as
FDA guidance and regulations
o 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
materials
o 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 appropriate
Required/Preferred Education and Licenses
B.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 eight years pharmaceutical
industry experience with at least 5 years' experience in regulatory
affairs advertising and promotion
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 , Director Promotional Regulatory Affairs, Executive , Palo Alto, California
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