Sr. Manager, Risk Evaluation and Mitigation Strategies (REMS)
Overview
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.
Position Profile
Position will provide support for FDA mandated Risk Evaluation and Mitigation Strategy (REMS) programs and other patient and product risk management initiatives. Role will support the Director level of the department in multiple department initiatives both in U.S. and global functions.This individual will provide support as a business analyst with emphasis in IT comprehension to fill the data generation, analysis, and reporting needs for risk management and REMS requirements. Role will provide information of on-going initiatives to senior management as required. Support presentation development and delivery to senior leadership.
Essential Functions
Support for U.S. FDA mandated REMS programs and Risk Management initiatives conducted for product and patient safety. Perform select active monitoring of products that require REMS programs, participant on shared REMS work-streams as necessary, support for multiple cross functional team efforts, data analysis for assessment reports and other agency requested information. Employee will contribute to the support necessary to meet strategies and tactics developed for the Risk Management department to include a significant focus in Information Technology in a Business Analyst role. Support for multiple REMS programs. Support of mandatory risk management plans in Europe and ROW. Support daily department functions required to meet business and regulatory requirements within team and cross-functional activities. Manage department meetings and schedule calendar initiatives required to meet regulatory requirements. Support development and submission of annual Assessment Report. Support daily function for support of multiple product responsibilities to meet REMS requirements. Provide support for post marketing activities as required by product portfolio and department responsibilities. Provide data analysis of various data collection for risk management insight and solution development.
Required Knowledge, Skills, and Abilities
- 1-3 years' experience in REMS program development and implementation, Benefit Risk Management, or Drug Safety in pharmaceuticals or equivalent.
- Information Technology desired
- Business analytics required
- Proficient computer and MS application required
- Project/program management desired
Required/Preferred Education and Licenses
- Advanced degree preferred; bachelor's degree (or equivalent) in relevant field,required
Description of Physical Demands
- Occasional mobility within office environment.
- Routinely sitting for extended periods of time.
- Constantly operating a computer, printer, telephone and other similar office machinery.
Description of Work Environment
- Work indoors in normal office environment with little exposure to excessive noise, dust, fumes, vibrations and temperature changes.
- Frequent computer use at workstation.
- May move from one work location to another occasionally.
- Responsibilities may require a work schedule that may include working outside of "normal" work hours, in order to meet business demands.
- Occasional public contact requiring appropriate business apparel.
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.