Associate Director GRADS Compliance Partner, REMS and PV (Remote)

Jazz Pharmaceuticals, Inc.; Harrow; Remote; GBP 70,000 - 90,000; Full time

Job summary

A global biopharma company in Harrow is seeking a leader for their global Pharmacovigilance (PV) and Risk Evaluation and Mitigation Strategies (REMS) efforts. The ideal candidate will provide strategic and operational leadership, ensuring compliance and oversight within the organization. Candidates must have 8 years of R&D quality experience and strong interpersonal skills. This role is pivotal in maintaining high standards of patient care through effective compliance.

Qualifications

• 8 years of R&D quality or compliance experience.
• 5+ years of experience communicating with senior leaders.
• Ability to function autonomously in a matrix model.

Responsibilities

• Provide GRADS Compliance support aligned with PV and REMS.
• Work with Compliance Operations to optimize compliance organization.
• Stay updated with health authority actions and regulations.

Skills

R&D quality management

Compliance experience

Interpersonal skills

Communication

Negotiation

Problem-solving

Education

B.S. in Science

Advanced degree

Job description

This role is responsible for providing strategic and operational leadership for global PV and REMS to execute the quality framework of controls and oversight necessary to achieve compliance, inspection readiness, and continuous improvement.

Essential Functions/Responsibilities:

• Provide overall GRADS Compliance support in line with the execution of PV and REMS processes and compliance requirements, while ensuring data and scientific integrity practices are followed and consistent with global policies and procedures.
• Work collaboratively with GRADS Compliance Operations to support the build and optimization of the GRADS Compliance organization.
• Participate in GRADS Compliance Council and support business to report on KPIs and escalated topics.
• Stay current with health authority actions and emerging regulations in global PV and REMS and share insights and advice with functional area leadership team.
• Conduct after action reviews jointly with GRADS Compliance Operations with PV and REMS functional areas to learn and improve after any compliance incident.
• Collaborate with GRADS Compliance Process and Training to design a strategy to pre-empt compliance issues.
• Partner with GRADS Compliance Operations and GRADS Alliance Management to review metrics of vendors for compliance concerns and opportunities.

Requirements:

• 8 years R&D quality or compliance experience or relevant experience in global PV or REMS.
• 5 + years' experience in working with and directly communicating with senior leaders with proven accountability, and demonstrated excellent interpersonal, communication, negotiation, influencing, and problem-solving capabilities.
• Proven ability to function autonomously at a senior level in a matrix model and in a team environment.
• B.S. in Science (or equivalent) required and advanced degree preferred.

Jazz Pharmaceuticals is a global biopharma company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life-changing medicines for people with serious diseases - often with limited or no therapeutic options.

We are an equal opportunities employer and welcome applications from all qualified candidates.