Associate Director, Compliance

Who We Are

Bio Marin is a leading rare disease biotechnology company focused on genetically defined conditions.

Guided by our purpose to develop medicines that make a profound impact on people’s lives, our global teams have delivered a portfolio of therapies since our founding in 1997.

Our revolutionary treatments for conditions like achondroplasia (the most common form of dwarfism), PKU (phenylketonuria), CLN2, a form of Batten disease, and a number of forms of MPS (mucopolysaccharidosis) offer new possibilities for patients and families who previously had few, if any, available options.

More recently, with the close of the Amicus acquisition, our portfolio has expanded to include therapies for Fabry disease and Pompe disease, expanding our ability to reach more people living with rare genetic conditions.

About Corporate Groups

It takes a village, and at Bio Marin, our general and admin teams are the village behind our success.

From the IT experts who manage our technology to the human resources professionals who hire the people who make it all possible, these teams support our organization and span all areas of operations.

• Associate Director, Corporate Compliance
• Summary Description

The Associate Director, Corporate Compliance serves as the Country Compliance Officer for Germany and is the primary compliance business partner to the German leadership team.

The role is responsible for overseeing the implementation and effectiveness of Bio Marin’s Compliance Programme within Germany, providing strategic and practical advice on healthcare compliance matters, and fostering a culture of ethics and integrity throughout the organisation.

While the primary focus of the role is Germany, the successful candidate will also have opportunities to support compliance activities in other European markets, including France and Italy, and contribute to regional and global compliance initiatives.

• Roles and Responsibilities
• Serve as the primary compliance advisor to the German team, providing practical and risk-based guidance on strategic business initiatives and fostering a culture of ethical decision-making;
• Lead the identification, assessment, and mitigation of compliance risks within Germany and oversee implementation of risk mitigation plans in partnership with business stakeholders;
• Support compliance activities in additional European markets, including France and Italy and contribute to regional and global compliance initiatives as required;
• Lead or contribute to regional and global compliance projects, including policy development, monitoring initiatives, investigations, training programmes and compliance programme enhancements;
• Provide strategic input into the development, implementation and maintenance of policies and procedures for the general operation of the Compliance Programme in Germany and its related activities to prevent illegal, unethical, or improper conduct;
• Periodically review and provide feedback on the intersection of global and regional corporate business policies and German law 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;
• Partner with Commercial, Medical Affairs, Market Access and other business functions to review and advise on promotional and non-promotional activities and associated materials / messaging, ensuring compliance with applicable laws, regulations, industry codes and company policies;
• Review of communications related to the company’s development programmes to ensure they accurately and appropriately inform interested parties as to relevant information about the status and progress of clinical trials;
• Maintain an effective and proactive compliance communication and training programme in Germany (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 ABAC risks associated with German partners and distributors;
• Manage ongoing maintenance of various healthcare compliance programme‑related activities and requirements, including but not limited to review of aggregate spend disclosure reports; activity reports; monitoring; and investigations.
• Ensure German transparency reporting requirements are satisfied;
• Support privacy and data protection initiatives as required in collaboration with the Global Privacy team;
• 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.);
• Oversee the consistent handling and resolution of compliance concerns and investigations across the region;
• 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;
• 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 tune in to key regional issues.
• Leadership Responsibility
• Direct Reports: None.
• Team

Scope: The Associate Director will report into and work closely with and under the direction of the Senior Director, Corporate Counsel as well as collaborate with the wider regional and global Corporate Compliance team.

The Associate Director will act as the Country Compliance Officer for Germany, with responsibility for supporting the implementation and effectiveness of Bio Marin’s Compliance Programme within Germany.

The role also contributes to regional European compliance initiatives and may provide support to additional European markets, including France and Italy, as required.

• Key Stakeholder Groups
• The position operates in a highly matrixed environment and regularly interacts with senior leaders and employees across multiple functions, including Commercial Operations, Medical Affairs, Market Access, Regulatory Affairs, Clinical Sciences, Patient Services, Finance, Human Resources, Procurement and Information Technology, as well as the broader legal and compliance and privacy teams.
• The role also engages with external stakeholders, including healthcare professionals, healthcare organisations, patient organisations, distributors, consultants, industry associations and external legal counsel as necessary.
• The role serves as the primary compliance business partner to the German Leadership Team and plays a key role in identifying, assessing, and mitigating compliance risks associated with Bio Marin’s operations and business activities in Germany.
• Must have: Minimum Requirements
• Bachelor's degree or equivalent in Law, Business, Life Sciences, Healthcare Compliance, Ethics, Public Policy or a related discipline.
• 5-8+ years of experience practicing law or working in healthcare compliance, pharmaceutical compliance, life sciences legal, ethics and compliance, or a related field.

In-house experience within a pharmaceutical, biotechnology, medical device or healthcare organisation strongly preferred.

Experience with a regulatory authority or major law firm is a plus.

• Demonstrated experience advising business stakeholders on healthcare compliance matters, including interactions with healthcare professionals (HCPs), healthcare organisations (HCOs), patient organisations, grants, sponsorships, transparency requirements, promotional and non‑promotional activities, and anti‑bribery/anti‑corruption compliance.
• Strong knowledge of the legal, regulatory and industry code framework applicable to the pharmaceutical and biotechnology industry, including anti‑corruption laws, transparency requirements, interactions with healthcare stakeholders, promotional regulations, clinical development activities and applicable industry codes.
• Experience conducting compliance risk assessments, investigations, monitoring activities and implementing corrective and preventive actions.
• Experience supporting commercial, medical affairs, market access, regulatory affairs and/or clinical development functions.
• Experience operating effectively within complex, highly regulated and matrixed multinational organisations.
• Experience supporting European markets, particularly Germany. Experience supporting France and/or Italy is desirable.
• Fluent German and English speaker.
• Nice to have
• Qualified lawyer (Germany or another European jurisdiction).
• Advanced degree (e. g., LL. M., Master's degree, MBA, or equivalent).
• Professional compliance certification (e. g., Certified Compliance & Ethics Professional (CCEP), Certified Fraud Examiner (CFE), or equivalent)
• Experience supporting other European markets is desirable.
• Note

This description is not intended to be all-inclusive, or a limitation of the duties of the position.

It is intended to describe the general nature of the job that may include other duties as assumed or assigned.

Equal Opportunity Employer/Veterans/Disabled

An Equal Opportunity Employer.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

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