Jazz Pharmaceuticals

Manager, R&D Process and Training

US-CA-Palo Alto | US-PA-Philadelphia | UK-Oxford | IE-Dublin | US-NJ-Ewing
3 weeks ago
Job ID
2017-1264
# of Openings
1
Category
Research & Development

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

A Manager of R&D Process and Training assists with the strategy, design, and implementation for continuous improvement of processes associated with R&D activities.  Continuous improvement includes the definition of processes in collaboration with the functions and development of documents and tools in support of those processes including training matrices.

                             

A Manager of R&D Process and Training participates in inspection readiness activities, and supports inspections and inspection responses in order to provide process knowledge and reflect that knowledge in documents to improve quality and compliance

Requirement:

  • Lead project teams in R&D to identify and implement improved efficiencies and industry best practices
  • Work with other R&D Process and Training colleagues to ensure new process and initiative outcomes are embedded in the organization for long term success
  • Follow best practices to assist R&D staff, including Pharmacovigilance groups, tasked with development, review, and approval of SOPs and Work Instructions
  • Assist R&D functions, including Pharmacovigilance groups, in creating and maintaining training matrices
  • Act as point of contact for maintaining sections of the Pharmacovigilance System Master File (PSMF)
  • Create and deliver training and provide guidance to other R&D staff creating presentations and training for their functions
  • Participate in ongoing inspection readiness activities and provide support for inspections; provide feedback from inspections to R&D functions to improve procedures and process documents

Education

  • BS or MS degree in Clinical or Scientific Discipline preferred.

Related Experience:

  • Knowledge of the overall drug development process
  • Direct experience with conduct of clinical trials and/or pharmacovigilance activities
  • Familiarity with health authority regulations
  • Involvement in process development/improvement within clinical development
  • Experience with SOP development and management and/or experience with GCP training matrices
  • Participation in inspections and inspection readiness activities desired
  • Proficient in Microsoft Office applications

General Skills:

  • Ability to orchestrate multiple activities at once in order to accomplish a goal
  • Strong oral and written skills
  • Effective problem solving skills
  • Effective project management skills
  • Demonstrated facilitation skills
  • Pro-active thinking
  • Highly committed to quality
  • Flexible and persistent
  • Good collaboration and networking skills
  • Good conflict handling/negotiation skills

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.

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