Associate Director, Global Compliance & EthicsLocation Dublin, Ireland Apply
By providing a foundation for all operations company wide, BioMarin’s General and Administrative teams support our mission of providing first and best in class therapeutics to patients who live with rare diseases. Our teams include groups such as finance, legal, human resources, corporate compliance and ethics, and information technology. Come join our team and make a meaningful impact on patients’ lives.
The Associate Director, Global Compliance & Ethics, European Union, Middle East and Africa region (“EUMEA”) under the direction of the Brand and Healthcare Compliance Lead –Director, Global Compliance & Ethics, will support the management of the Compliance Program relating to BioMarin’s operations in EUMEA which, in collaboration with the Global Compliance & Ethics department, functions as an independent and objective body that reviews and evaluates compliance issues/concerns within the organisation.
From a geographical perspective the role will be the first point of contact for compliance queries from management in a number of EUMEA countries. Matrixed on top of these responsibilities is a focus on a number of BioMarin’s core therapy areas across all of the EUMEA region, in particular the ERT franchise.Generally, the position supports the Brand and Healthcare Compliance Lead who along with the broader team is responsible for ensuring that EUMEA management and employees are in compliance with the rules and regulations of regulatory agencies, that company policies and procedures are being followed, and that behaviour in the organisation meets the company’s Standards of Conduct, as outlined in the Global Code of Conduct and Business Ethics. In addition, theAssociate Dircetor will support interactions with third parties with whom BioMarin conducts business in order to ensure compliance with applicable anti-corruption laws, transparency reporting requirements, and other external legal/compliance responsibilities are met.
- Support in the development, implementation and maintenance of policies and procedures for the general operation of the Compliance Program and its related activities to prevent illegal, unethical, or improper conduct;
- Periodically review and update regional corporate business policies to ensure continuing relevance in providing guidance to management and employees;
- Collaborate with other company functions, including, but not limited to Commercial Operations, Medical Affairs, Clinical Sciences and Regulatory Affairs to provide advice and counsel regarding potential compliance issues and risks;
- Draft memoranda providing analysis and risk-based recommendations regarding various compliance rules and regulations implicated by proposed or existing business strategies;
- Evaluate, approve, and monitor company interactions with healthcare professionals, healthcare organisations, patient organisations and other relevant third parties, to ensure they are compliant and permitted for appropriate business purposes, including organisation of advisory boards, meetings and scientific congresses;
- Work with the Sales and Marketing teams to review promotional materials for approved products to ensure, among other things, the pieces are compliant with applicable rules and regulations, are not misleading in any way and balance risks and benefits associated with treatments;
- Review of communications related to the company’s development programs to ensure they accurately and appropriately inform interested parties as to relevant information about the status and progress of clinical trials;
- Support the maintenance of an effective and proactive compliance communication and training program for the EUMEA region (through Learning Management System and Live trainings), including promoting use of the compliance hotline and expeditiously and thoroughly fielding questions relating to new and existing compliance issues and related policies and procedures raised by management and employees;
- Support global anti-bribery/anti-corruption efforts, including managing the due diligence program relating to the organisation’s partners and distributors;
- Manage ongoing maintenance of various healthcare compliance program-related activities and requirements, including but not limited to review of aggregate spend disclosure reports; activity reports; monitoring; and investigations.
- Manage and collaborate with Global Compliance & Ethics colleagues to ensure EUMEA region transparency reporting requirements are satisfied;
- Assist the Global Compliance and Ethics team in managing the privacy and data protection program throughout all company functions;
- Investigate alleged violations of laws, regulations, company policies and procedures, and/or the Global Code of Conduct and Business Ethics by evaluating and/or recommending the initiation of investigative procedures in, collaboration with other internal stakeholder groups (e.g., Human Resources, Information Technology, etc.);
- Assist in developing and overseeing a system for uniform handling of such violations;
- Implement corrective action plans for resolution of compliance issues, and provide guidance on how to avoid or deal with similar situations in the future;
- Remain current on external legal and compliance trends in the biopharmaceutical industry to identify potential areas of compliance vulnerability and risk;
- Consult with outside counsel as needed to resolve difficult, complex or particularly sensitive legal/compliance issues; and
- Provide reports on a regular basis, and as directed or requested, to keep Global Compliance & Ethics, other functions and senior management informed of the operation and progress of the EUMEA region’s compliance effort and tuned in to key regional issues.
An integral part of the job will be working with the Executive Director of EUMEA Compliance to support and embed the growth strategy for the region in order to provide appropriate Compliance support.
The EUMEA region will soon be hitting USD$1BN revenues in over 50 countries and the continued success of the company relies on it being and remaining compliant across a variety of international compliance landscapes.
A Bachelor’s degree is required; a law degree is required as well as being a qualified lawyer in a EUMEA jurisdiction.
- A minimum 5 years of experience practicing law or working in the pharmaceutical/healthcare compliance field. In-house experience at a pharmaceutical/biotechnology organisation or regulatory agency strongly preferred. Major law firm experience is plus.
- Experience with and/or understanding of corporate compliance issues confronting the pharmaceutical, biotechnology, and/or healthcare industry generally.
- Demonstrated knowledge and understanding of the legal and regulatory framework affecting the pharmaceutical/biotechnology industry; including, but not limited to, sales and marketing fraud and abuse issues and other industry guidance documents, EU country regulations on the promotion of marketed products, clinical trial regulations, and issues arising under the Anti-bribery and Anti-corruption global law.
- Demonstrated effectiveness operating in complex organisational and regulatory environments.
- Excellent written and verbal communication and interpersonal skills.
- Proven ability to work with all levels of management and the general workforce.
- Strong problem solving and risk analysis skills.
- Demonstrated ability to partner effectively with others in a matrixed organisation to ensure addressing complex issues.
- Strong persuasive skills and sound business judgment.
- Motivated, self-starter with ability to appropriately prioritise issues and allocate resources. Sound project management skills.
Must be willing to work in a team environment and be able take direction from multiple stakeholders. Must be willing to travel, including internationally, both as needed and regularly. Travel may fluctuate, but on balance will be between 20% and 30%.
We are an equal opportunity 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 other characteristic protected by law.