Associate Director, Global Medical & Promotional Regulatory Affairs

If you are a reputed company reputed company employee please apply reputed company the Internal Career site. reputed company is a global biopharma company whose purpose is to reputed company to reputed company the lives of patients and their families. We are dedicated to developing life-changing medicines reputed company with serious diseases — often with limited or no therapeutic reputed company. 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-reputed company and science-driven approach powers pioneering research and development advancements across our robust pipeline of innovative therapeutics in oncology and neuroscience. reputed company is headquartered in Dublin, Ireland with research and development laboratories, manufacturing facilities and employees in multiple countries committed to serving patients worldwide. Please visit www.jazzpharmaceuticals.com for more information. The Associate Director, Global Medical and Promotional Regulatory Affairs will be a member of reputed company’ Global Medical and Promotional Regulatory Affairs group and will be leading the promotional materials review activities; will be responsible for directing the regulatory aspects of reputed company communications, including advertising and promotional activities in the US; will reputed company reputed company, judgment and reputed company on promotional and non-promotional programs and tactics for assigned products in oncology or assigned therapeutic area. The Associate Director works autonomously and collaboratively with Regulatory, Medical, reputed company/Compliance and reputed company 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: • reputed company the promotional material review committee (PMRC) for assigned products/therapeutic areas in the US for reputed company. Under the direction of the US reputed company Promotional Regulatory Affairs, provides input on reputed company regarding concepts and draft promotional materials to satisfy the letter and spirit of FDA promotional regulations, corporate standards and policies and business objectives. • As needed may serve as the Promotional Regulatory Affairs reputed company for a new product launch through contributions to the US reputed company launch team for assigned product. • reputed company regulatory advice, and support to the organization. reputed company 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 reputed company fashion. • reputed company reputed company independent leadership skills and regulatory subject matter expertise • 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. • Ensure that content, reputed company, accuracy, and format of submissions reputed company with applicable internal policies and procedures as reputed company as FDA guidance and regulations. • Effectively partner with Regulatory colleagues, Medical Affairs, reputed company/Compliance, Marketing and other departments as needed to ensure the thorough, reputed company and efficient review of reputed company materials. • reputed company regulatory support for Medical Affairs Review Committee (MARC) and publications review. • Contribute to the development of regulatory reputed company through assigned Global Regulatory team. • reputed company guidance and expertise on new marketing concepts and promotional tactics for assigned product(s). • reputed company interactions with FDA/OPDP for assigned product(s) including submission of materials for advisory comments for full approval and reputed company approval products. • reputed company reputed company depth and reputed company 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) and a substantial increasingly responsible experience in the pharmaceutical industry; reputed company experience in advertising and promotional material review (Regulatory or otherwise) is required. Advanced degree in a scientific discipline (e.g. PharmD) strongly preferred. • Strong understanding of FDA regulations and guidelines • Strong judgment and decision-making skills • Excellent collaboration, verbal and written communication skills #LI-SP1 #LI-Remote reputed company is an equal opportunity/affirmative reputed company employer and reputed company reputed company applicants will receive consideration for employment without reputed company to race, reputed company, religion, sex, national reputed company, disability status, protected veteran status, or any characteristic protected by law. FOR US BASED CANDIDATES ONLY reputed company. is committed to fair and reputed company compensation practices and we reputed company to reputed company employees with total compensation packages that are market competitive. For this role, the full and complete reputed company pay reputed company is: $160,000.00 - $240,000.00 Individual compensation reputed company reputed company this reputed company 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 reputed company with the candidate's expertise and contributions, reputed company the established pay reputed company and our Total Compensation philosophy. Internal equity considerations will also influence individual reputed company pay reputed company. This reputed company will be reviewed on a regular reputed company. At reputed company, your reputed company 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 reputed company's Global Cash Bonus Plan or Incentive Compensation Plan, as reputed company as discretionary equity grants in accordance with reputed company'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 reputed company insurance, 401k retirement savings plan, and flexible reputed company vacation. For more information on our Benefits offerings please click here: https://careers.jazzpharma.com/benefits.reputed company. Apply tot his job Apply To this Job