We care. Through pharmaceutical innovation and a strong commitment to global healthcare partnerships, we are dedicated to providing the tools, knowledge and science to improve the health of patients worldwide. We research, develop, manufacture and market our own medicines as well as a portfolio of licensed products designed to respond to the needs of different therapeutic areas. Today, our products are available in over 70 countries, on 5 continents, through 15 affiliates. Find out how we work every day to help to transform lives through science.
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MissionAs the Compliance Director for Biologics, you will serve as a strategic partner for our biologics portfolio, providing risk-based advice and solutions, ensuring adherence to complex compliance regulations and fostering a culture of integrity across the organization. You will lead compliance efforts, support strategic initiatives, and act as a key advocate for ethical practices.
Tasks and Responsibilities• Strategic Partnership: Collaborate with various teams to understand strategic priorities and navigate complex compliance regulations, identifying business implications and develop effective solutions.
• Relationship Building: Establish and maintain strong relationships across the business to enhance understanding of risk and compliance.
• Global Compliance Reference: Serve as the primary point of contact for global teams on compliance and promotional matters for current strategic biologic products and future launches.
• Compliance Strategy Development: Support the development of global compliance strategies together with the Executive Director, Compliance & Privacy.
• Promotional Compliance Leadership: Assume global responsibility for all aspects of promotional compliance for strategic biologic products, leading the compliance effort within cross-functional teams and task forces. Oversee compliance efforts related to materials, meetings, omnichannel initiatives, and provide expert guidance and training.
• Affiliate Compliance Supervision: Supervise and align affiliate compliance requirements, acting as a valued business partner. Drive continuous improvement of the compliance framework, including governance structures and monitoring mechanisms.
• Ethics and Integrity Advocacy: Champion the company's commitment to the Code of Ethics and Business Integrity Guide principles, advocating for ethical practices within the organization.
• Events: Partner with the Events Team before meetings and events and support strategic engagement with stakeholders and ensure compliance.
• General Counsel Collaboration: Actively participate as a key member of the General Counsel Area, fostering innovation and continuous improvement within the team.
• Monitoring: Implement routine monitoring in accordance with the global compliance plan.
• Training and Improvement Initiatives: Coordinate and direct training initiatives, propose and execute continuous improvement activities, and elevate compliance standards.
• Issue Escalation and Resolution: Ensure timely escalation and resolution of potential compliance issues, keeping senior management informed.
• External Representation: Act as the external compliance representative for business partnerships with industry associations and regulators, as needed.
• At least 8-10 years of experience in a compliance role, with a focus on areas such as promotional advertising, anti-bribery, anti-corruption, and sanctions. Experience in the pharmaceutical or biotechnology industry is highly desirable.
• Strong communication skills, with experience in effectively communicating compliance matters to senior leadership and other stakeholders.
• Proven experience in leading and managing compliance teams, including developing and implementing a compliance program.
• Experience with compliance tools such as Veeva PromoMats, CRM, OneTrust and MediSpend helpful.
• Experience in Farmaindustria Code of Practice and knowledge in EFPIA and IFPMA Codes.
• A bachelor's degree in law, business, life sciences or a related field desirable. Advanced degrees or certifications in compliance or related areas such as Certified Compliance & Ethics Professional (CCEP) are advantageous.
• High level of proficiency in English, both written and verbal.
• Change management: ability to drive, implement and communicate change related to processes such as material review, content management, training, and communication.
• Proactivity: Demonstrated ability to proactively drive business objectives, suggest new approaches, and initiate projects.
• Accountability: Strong capacity to explain actions and thought processes, providing clear reasons for decisions.
• Autonomy and Independence: Ability to work independently, make decisions autonomously, and seek help when necessary.
• Analytical Skills: Strong analytical and problem-solving skills to assess compliance risks and develop effective solutions.
• Interpersonal Skills: Excellent interpersonal skills to build relationships and collaborate with various stakeholders.
• Attention to Detail: High attention to detail to ensure compliance with regulations and internal policies.
• Ethical Judgment: Strong ethical judgment and integrity to uphold the company's compliance standards.
• Care: we listen & empathize, we value diverse perspectives & backgrounds and we help each other succeed
• Courage: we challenge the status quo, we take full ownership and we learn from our success & failures
• Innovation: we put the patient and customer at the center, we create novel solutions and we empower entrepreneurial mindsets
• Simplicity: we act decisively and avoid over-analysis, we understand why before we act and we are agile & keep things simple.