Director, Global Medical and Promotional Regulatory Affairs (Palo Alto) Job at MedStar Health, Palo Alto, CA

ZkRINWJDbllSbDFYS1VIKzZKcGVoMnFKS3c9PQ==
  • MedStar Health
  • Palo Alto, CA

Job Description

If you are a current Jazz employee please apply via the Internal Career site.

Jazz Pharmaceuticals is a global biopharma company whose purpose is to innovate to
transform the lives of patients and their families. We are dedicated to developing
life-changing medicines for people with serious diseases - often with limited or no
therapeutic options. We have a diverse portfolio of marketed medicines, including leading
therapies for sleep disorders and epilepsy, and a growing portfolio of cancer treatments.
Our patient-focused and science-driven approach powers pioneering research and development
advancements across our robust pipeline of innovative therapeutics in oncology and
neuroscience. Jazz is headquartered in Dublin, Ireland with research and development
laboratories, manufacturing facilities and employees in multiple countries committed to
serving patients worldwide. Please visit

for more information.

The Director, Global Medical and Promotional Regulatory Affairs will be a member of Jazz Pharmaceuticals' Global Medical and Promotional Regulatory Affairs group and will be assuming a leadership role in the promotional materials review; will be responsible for directing the regulatory aspects of internal and external communications, including advertising and promotional activities in the US; will provide insight, judgment and sound decisions on promotional and non-promotional programs and tactics for assigned products in oncology or assigned therapeutic area. The Director works autonomously and collaboratively with Regulatory, Medical, Legal/Compliance and Commercial organizations. The individual develops and applies expertise to ensure promotional programs and tactics are compliant with regulations and company policies while supporting the achievement of business objectives.

Essential Job Functions:

  • Lead the promotional material review committee (PMRC) for assigned products/therapeutic areas 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

  • Presents clear position statement and risk analysis to leaders in the regulatory department, medical affairs and other departments as needed

  • Serve as the Promotional Regulatory Affairs lead for a new product launch through contributions to the US Core launch team for assigned product in oncology.

  • 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.

  • 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

  • Exercise independent leadership skills and regulatory subject matter expertise

  • Work closely with thePromotional Regulatory Affairs lead and other team members to develop regulatory subject matter expertise and leadership skills

  • Provide regulatory support for Medical Affairs Review Committee (MARC)

  • Contribute to the development of regulatory strategy through assigned Global Regulatory team

  • 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.

  • Substantial pharmaceutical industry experience with proven experience in regulatory affairs advertising and promotion

  • Experience with Oncology and 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.

FOR US BASED CANDIDATES ONLY

Jazz Pharmaceuticals, Inc. is committed to fair and equitable compensation practices and we strive to provide employees with total compensation packages that are market competitive. For this role, the full and complete base pay range is: $188,800.00 - $283,200.00

Individual compensation paid within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, and other pertinent factors. The goal is to ensure fair and competitive compensation aligned with the candidate's expertise and contributions, within the established pay framework and our Total Compensation philosophy. Internal equity considerations will also influence individual base pay decisions. This range will be reviewed on a regular basis.

At Jazz, your base pay is only one part of your total compensation package. The successful candidate may also be eligible for a discretionary annual cash bonus or incentive compensation (depending on the role), in accordance with the terms of the Company's Global Cash Bonus Plan or Incentive Compensation Plan, as well as discretionary equity grants in accordance with Jazz's Long Term Equity Incentive Plan.

The successful candidate will also be eligible to participate in various benefits offerings, including, but not limited to, medical, dental and vision insurance, 401k retirement savings plan, and flexible paid vacation. For more information on our Benefits offerings please click here:

#J-18808-Ljbffr

Job Tags

Full time, Worldwide, Flexible hours,

Similar Jobs

Apple Air Heating & Cooling

Customer Service Representative Job at Apple Air Heating & Cooling

 ...Overview Looking to continue your career in customer service? Apple Air Heating Cooling Electric & Plumbing , part of the renowned Apex Service Partners network, is a leader in providing high-quality HVAC solutions across Long Island. With over 38 years of expertise... 

GREATER BINGHAMTON HEALTH CENTER

Chief Nursing Officer Job at GREATER BINGHAMTON HEALTH CENTER

 ...Job Description Recruiting Director of Nursing/Chief Nursing Officer Greater Binghamton Health Center (GBHC), a Joint Commission...  ...Nursing Officer and is a member of GBHCs executive management team. Duties As the Chief Nursing Officer, you will oversee... 

Tri-State Horizons Inc.

Entry Level Marketing Manager Trainee Job at Tri-State Horizons Inc.

 ...Job Description Job Description Entry Level Sales/ Marketing Manager - Weekly pay $600 - $1200 West Columbia, SC Immediate Start No Experience Required Degree Not Required If you are bored of having a job and want a career, then this is the opportunity... 

Headway

TELE LCSW - WORK FROM HOME !! Job at Headway

 ...Remote Licensed Clinical Social Worker (LCSW) Wage: Between $...  ...providing and overseeing medication management. Whether you're new to private...  ...you can set the hours that work for you. Grow your caseload...  ...telehealth while working from home. We accept the following... 

Beth Israel Lahey Health

HCA Primary Care Lead Medical Assistant Job at Beth Israel Lahey Health

 ...diverse populations including patients, medical staff practitioners and medical center personnel.At BIDMC, a Medical Assistant in a hospital-based practice is not authorized to perform duties that can be performed only by licensed personnel, which includes, but is not...