Overview
In this role, you will serve as Germany’s primary compliance advisor, guiding the local business within BioMarin’s global compliance programme. You will lead risk assessment and mitigation efforts, partner with cross-functional teams, and drive regional and global compliance initiatives. You will shape policies and training to foster an ethical culture and ensure adherence to laws, codes, and transparency requirements. This is a strategic, cross-market position with opportunities to support additional European markets and influence regional compliance execution.
Verantwortungsbereiche
- Act as the primary compliance advisor to the German leadership team and provide risk-based guidance on strategic initiatives
- Identify, assess, and mitigate compliance risks in Germany and coordinate risk mitigation with business stakeholders
- Support compliance activities in France and Italy and contribute to regional/global initiatives
- Lead/contribute to regional/global projects (policies, monitoring, investigations, training, programme enhancements)
- Develop and maintain policies/procedures for the German Compliance Programme
- Review global vs. regional policies for relevance to German law
- Collaborate with Commercial, Medical Affairs, Market Access, Regulatory Affairs to address compliance risks
- Draft risk-based memoranda on rules and regulations implicated by business strategies
- Evaluate, approve, and monitor interactions with HCPs, HCOs, patient organisations, and third parties for compliance
- Partner with other functions to review promotional and non-promotional materials and activities for legal and policy compliance
- Review communications about development programmes to accurately reflect trial status
- Maintain a proactive training programme in Germany via LMS and live trainings
- Support ABAC efforts and manage German partner/distributor risks
- Maintain compliance programme activities, including reviews, monitoring, investigations, and transparency reporting
- Ensure German privacy/data protection initiatives in collaboration with Global Privacy
- Investigate alleged violations and initiate investigations as needed
- Oversee consistency of regional compliance responses and implement corrective actions
- Stay current on industry trends to identify vulnerabilities; consult outside counsel as needed
- Provide regular updates to Global Compliance & Ethics and senior management
Zentrale Anforderungen
- Bachelor's degree or equivalent in Law, Business, Life Sciences, Healthcare Compliance, Ethics, Public Policy or related field
- 5-8+ years in healthcare/pharmaceutical compliance or related field; in-house pharma experience preferred
- Proven experience advising stakeholders on interactions with HCPs, HCOs, patient organisations, grants, sponsorships, and promotions
- Strong knowledge of pharma/biotech regulatory frameworks, anti-corruption, transparency, and clinical development rules
- Experience with risk assessments, investigations, monitoring, and CAPA implementations
- Experience supporting commercial, medical affairs, market access, regulatory, and/or clinical development functions
- Ability to operate in complex, multinational, highly regulated environments; familiarity with European markets, especially Germany; France/Italy desirable
- Fluent German and English
- Nice to have: Qualified lawyer, advanced degree, professional compliance certification
- Note: role requires willingness to travel as needed
- collaboration with cross-functional teams
- strong communication and advisory skills
- ethics and integrity
- Regulatory compliance knowledge for pharma/biotech
- Risk assessment and investigations
- ABAC and anti-bribery/anti-corruption compliance
Associate Director, Compliance in Düsseldorf Arbeitgeber: BioMarin Pharmaceutical
BioMarin ist ein hervorragender Arbeitgeber, der sich durch eine engagierte und innovative Unternehmenskultur auszeichnet. Mit einem klaren Fokus auf die Entwicklung von Therapien für seltene Krankheiten bietet das Unternehmen nicht nur bedeutende Wachstums- und Entwicklungsmöglichkeiten für seine Mitarbeiter, sondern auch die Flexibilität eines Remote-Arbeitsmodells in Deutschland. Hier haben Sie die Möglichkeit, in einem dynamischen Umfeld zu arbeiten, das von Zusammenarbeit und einer starken Mission geprägt ist, die Lebensqualität von Patienten weltweit zu verbessern.
