Associate Director, Benefit Risk Management
Posted on May 14, 2019 by Jazz Pharma
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:
This position will provide regulatory support for FDA-mandated Risk Evaluation and Mitigation Strategy (REMS) programs in the US, relevant post marketing requirements as well as EX-US risk management activities and initiatives. This individual will lead cross-functional teams and the generation of and analysis of business data for internal review and reporting to government agencies. Lead development of external reports required by governmental oversight bodies as required. Provide guidance to vendors being directly managed by Benefit Risk Management (BRM) Department. Provide necessary training to team members working directly on department initiatives regarding regulatory reports. Support department Director in strategy initiatives and communications to external stakeholders. Support travel needs to support initiative to foster excellence to JPI portfolio managed by BRM team. Work occasionally with external legal guidance partners on matter that involve direct involvement from JPI legal direction for decisions. Participate in designated initiatives to support BRM global expansion. Participate in development and maintenance of dept. and team training materials specifically focused on Risk Management Reports associated with REMS programs.
- Leading role on cross-functional teams for individual and shared REMS programs and EX-US Risk Management Plans
- Support strategic initiatives as internal team liaison for information
- Work to advance/innovate the science of risk management within the company
- Drive to completion data collection and critical analysis efforts for assessment reports and other agency requested information
- Work directly with vendors performing REMS or risk management activities
- Help lead process improvement activities
- Develop necessary training for data collection as JPI continues to globalize portfolio
- Conduct research in support of commercial products and development project as it relates to risk management requirements
- Responsible for leading projects with cross-functional involvement
- Bachelor's Degree and three or more years of Pharmaceutical experience OR an Advanced degree and six or more months of Pharmaceutical experience or an equivalent combination of education and experience.
- Familiarity and exposure to REMS and risk management programs, submissions and implementation - Background in Drug Safety experience will be considered as well
- Industry or pharmacy experience working with REMS programs in specialty pharmacies is preferred
- Demonstrated business and data analytics abilities
- Advanced computer and database skills
- Strong communication skills
- Ability to work well in a cross-functional team
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.