Jazz Pharmaceuticals plc (NASDAQ: JAZZ) is a global biopharmaceutical 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 have a diverse portfolio of marketed medicines and novel product candidates, from early- to late-stage development, in neuroscience and oncology. We actively explore new options for patients including novel compounds, small molecules and biologics, and through cannabinoid science and innovative delivery technologies. Jazz is headquartered in Dublin, Ireland and has employees around the globe, serving patients in nearly 75 countries. For more information, please visit www.jazzpharmaceuticals.com and follow @JazzPharma on Twitter.
Brief Description
The Ethics & Compliance Officer supports the Affiliate in all the activities related to the global compliance program and compliance with the local regulatory / compliance environment including provision of advice to business partners, maintenance of local processes and procedures, implementation of global governance within the affiliate, support for the global / regional training program as well as providing local training and support for the global monitoring plan and remediation of findings. Working closely with the local affiliate Leadership Team and with other key process owners in the Country, the Ethics & Compliance Officer is responsible for advising on the potential compliance risks of any activity ruled by local legislation and company policies.
Responsibilities
- Act as a business partner working closely with key stakeholders across the affiliate providing compliance advice, support and guidance to ensure activities are undertaken in a manner compliant with local legislation and Jazz policies and procedures
- Ensure the execution of global and regional compliance initiatives at the local level including implementation of appropriate systems and controls to ensure compliance
- Foster a culture of integrity and ethical behaviour across and throughout the affiliate
- Oversee and strengthen the implementation of compliance initiatives and adherence from local teams
- Facilitate compliance program improvements to address corporate compliance risks and feedback best practice to help inform regional and global compliance strategies
- Provide compliance training to affiliate staff, aligned to their function and role, in line with the global / regional training plan
- Support delivery of the global / regional monitoring plan through coordinating document requests, investigation of deviations and violations and support the implementation of appropriate corrective and preventative actions
- Monitor and analyse the regulatory environment in which the affiliate operates, determine the potential impact of regulatory changes on the EUR/INT compliance program, and implement necessary changes to compliance policies and processes
- Work closely with the EUR/INT Ethics & Compliance Team to ensure consistency of approach across the region
- Ensure that information required to meet Transparency Disclosure requirements is reviewed for completeness and accuracy in collaboration with the local country stakeholders and the global Transparency Team
- Coordinate the activities of the affiliate compliance committee and ensure that key issues identified are appropriately escalated to the EUR/INT compliance committee
Required Knowledge, Skills, and Abilities
- A minimum of 7 years of Legal/Compliance experience in the pharmaceutical industry
- Experience of leading a life sciences compliance function at a country level
- Knowledge of the local legislation relevant to the pharma market, the local industry association Code of Practice as well as SOPs, policies and procedures
- Experience working with key stakeholders from across the business and the ability to influence outcomes
- Experience with systems that facilitate an effective compliance program
- Flexibility
- Conflict management
- Problem solving
- Cross functional working
- Fluent language skills for the country in which they are based
- Excellent English language skills.
Required/Preferred Education and Licenses
- Bachelor Degree in an appropriate subject is preferred.
Jazz Pharmaceuticals is an Equal Opportunity Employer.
