SUMMARY DESCRIPTION

The Associate Director, Global Compliance & Ethics - Europe and Canada, will, under the direction of the Brand and Healthcare Compliance Lead, Global Compliance & Ethics, support the development and management of the Compliance Program which, in collaboration with the Global Compliance & Ethics department, functions as an independent and objective body that reviews and evaluates compliance issues/concerns across BioMarin.

From a geographical perspective the scope of the role will focus on one or two of the core strategic markets (France, Germany and Italy) markets within the wider Europe and Canada region, with a specific focus on the ongoing launch of BioMarin’s gene therapy for Haemophilia  and other therapeutic brands across the entire BioMarin portfolio.  Matrixed on top of these responsibilities will be a number of general compliance and privacy responsibilities that span the entire Europe and Canada region.

Generally, the position supports the Brand and Healthcare Compliance Lead who along with the broader team is responsible for ensuring that advertising and promotion material and activities are aligned with relevant laws, regulations and codes; that the European and Canadian  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, the Associate Director 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. 

RESPONSIBILITIES

·       Review all external facing product and disease awareness material and activities to ensure that risks associated with improper advertising and promotion are managed appropriately in accordance with the BioMarin corporate risk tolerance, including:

o   Working 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;

o   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 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;

·       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.

·       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 Europe and Canadian region’s compliance effort and tuned in to key regional issues.

SCOPE

The Europe and Canada region will soon be hitting USD$.75BN revenues in over 40 countries with a specific focus on one or two (out of France Germany and Italy) of six of the globally identified key strategic markets for BioMarin. The continued success of the company relies on it being and remaining compliant across a variety of international compliance landscapes.

EDUCATION

Qualified lawyer in a European jurisdiction. German, Italian or French qualifications a plus.

EXPERIENCE

·       A minimum 5 years of experience practicing as a brand lawyer or other lawyer 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 of reviewing and advising on  arrange of issues relating to the promotion and advertising of pharmaceutical products in Europe.

·       Language skills (one of German, French, Italian) a strong 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.

WORK ENVIRONMENT

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%.