Labeling Operations Manager
Posted on Jun 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:
The Senior Manager, Labeling Operational Excellence will be responsible for providing support in the management, assessment and prioritization of process, quality, and compliance in order to meet regulatory labeling requirements. The individual will be responsible for driving higher performance through process improvement efforts, conducting quality and compliance reviews and providing periodic reports to functional leaders. This person will utilize his/her experience to develop, maintain, and implement labeling governance documents and associated training materials. The individual will routinely interact cross-functionally with colleagues within and external to R & D.
- Establish and maintain a plan for the review of governance documents and associated training
- Establish and maintain continuous improvement of Labeling process and documentation, including information in the Jazz information management system
- Manage quality control over entire labeling process and management of revisions, including assigning/tracking projects, workflow execution, and issue resolution
- Develop and provide key metrics and reports related to labeling processes and systems to leadership and key stakeholders, as required
- Maintain an awareness of regulations affecting the global pharmaceutical/biologics industry
- Build, maintain and leverage relationships across Jazz to identify opportunities for process improvement and facilitate the implementation and continuous monitoring of labeling and related processes
Required Knowledge, Skills, and Abilities
- Minimum of 5-7 years of increasingly responsible experience in the pharmaceutical industry, including at least 3 years of direct experience in Labeling, preferably in a global setting, or other Regulatory Affairs functions
- Applies in-depth knowledge of broader departmental objectives to analyze/solve issues
- Applies strategic insight to determine best-fit methods, techniques and metrics
- Track record of success in the rigorous planning, execution and timely delivery of projects and / or programs
- Proven ability to identify opportunities and translate to tangible initiatives through successful execution of projects
- Builds relationships, able to negotiate & influence, and manage change in matrix environment
- Outstanding verbal and written communication skills
- Proven leadership and interpersonal skills
- Technical: Skilled in Powerpoint, Excel. Knowledge of Data management systems
Required/Preferred Education and Licenses
- Bachelor's degree required (Scientific discipline preferred)
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.