Experience Inc. Jobs

Reference #: R009697 If you are a current Jazz employee please apply via the Internal Career site. Jazz Pharmaceuticals plc (NASDAQ: JAZZ) is a global biopharmaceutical 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 and novel product candidates, from early- to late-stage development, in neuroscience and oncology. We actively explore new options for patients including novel compounds, small molecules and biologics, and through cannabinoid science and innovative delivery technologies. Jazz is headquartered in Dublin, Ireland and has employees around the globe, serving patients in nearly 75 countries. For more information, please visit www.jazzpharma.com and follow @JazzPharma on Twitter.

Essential Functions: Lead resources needed to support Global Product Labelling activities to support business needs for product registrations, including input into label budget discussions Lead and provide project management to the Labelling Committee throughout the entire process, from the decision to update a CCDS and product information (including patient information labelling) through notification to stakeholders, to ensure that these documents are produced in a timely manner according to internal SOPs and external regulatory requirements When developing new labels, research the content of other labels in the same therapeutic class, including competitor labelling, to help guide the team in developing labelling text, including contingency strategy development for negotiation with regulatory authorities Schedule, coordinate and lead LC meetings and final internal endorsements Maintain expertise regarding key labelling requirements worldwide and stay current with labelling guidelines and regulations as they pertain to the development/maintenance of labelling and advise key stakeholders on the application of these labelling principles Maintain controlled records for historical, current, and proposed labelling changes, and communicate labelling changes to necessary stakeholders at the time of implementation Manage quality control over entire labelling process and management of revisions, including assigning/tracking projects, workflow execution, and issue resolution Assist in implementing process improvements to increase the efficiency and effectiveness of the label review process Required Knowledge, Skills, and Abilities: Minimum of 10 years of increasingly responsible experience in the pharmaceutical industry, including at least 6 years of direct experience in US/EU product labeling Proven experience associated with product labelling regulations and fluency in ways of working with Regulatory Agencies Strong judgement and decision making skills Excellent written and verbal communication skills Ability to review regulatory labelling documents for accuracy and adherence to regulatory requirements, noting deficiencies and inconsistencies 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 project team members Ability to travel occasionally - approximately 10-20% regional and/or international travel Responsibilities may require working outside of "normal" hours, in order to meet business demands Required/Preferred Education and Licenses: Bachelor's degree required (Scientific discipline preferred) Proven experience in regulatory affairs with particular focus on labelling

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: $188,000.00 - 282,000.00 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: https://careers.jazzpharma.com/benefits.html.

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.