The Global Head of Compliance is responsible, for the development and implementation of an effective Healthcare Compliance Program, and ensuring a culture of compliance at all levels. The Compliance Director ensures that the company and its employees are in compliance with applicable healthcare-related laws and regulations in all the countries where Galapagos is performing its business, with a focus on interactions with, and communication to healthcare professionals (‘HCP’s), patients, and their organizations, and the general public.
Furthermore, the CD will ensure that company policies and procedures are being developed, continuously updated where relevant, and adhered to. These policies include amongst others guidelines on interactions with healthcare professionals and patients, the provision of services to the Company, sponsorships and promotional materials. The CD reviews and evaluates, if needed with relevant co-workers, proposed promotional and non-promotional materials, meetings and hospitality arrangements with HCP’s, sponsorship and service agreements and compliance issues/concerns within the company; monitors and reports results of the compliance/ethics efforts of the company and proposes remedial actions; is responsible for leading multi-disciplinary efforts within the company related to compliance; and provides guidance for senior and line management on matters relating to compliance. This position also supports the global project teams and provides guidance to future local compliance colleagues.
• Strengthen the culture of compliance at the company, including by partnering with department heads, or the creation of a local/global compliance committee, and in the near future also with country general managers, medical directors and local compliance colleagues.
• Ensures that appropriate policies and procedures are created, continuously updated, communicated, through continuous education programs to employees, and that these are adhered to in order to prevent illegal, unethical, or improper conduct.
• Develops and coordinates an effective compliance training program to ensure that all Galapagos’ employees are knowledgeable of, and comply with, current laws and regulations and company policies.
• Ensures that potential compliance issues/concerns within the organization are being appropriately evaluated, investigated, and resolved. This includes the creation of manners in which colleagues are encouraged to communicate, internally, potential concerns they may have to their line managers or, directly, to the Compliance Director.
• Establishes and implements periodic risk assessments, audits, and reporting procedures to identify potential areas of compliance vulnerability and risk. Develops, agrees with local leadership teams, and implements preventative and corrective action plans to mitigate identified risks. Development of local and global risk assessment processes.
• Develops and implements auditing, monitoring, and reporting programs to monitor compliance with applicable laws, regulations, policies, and procedures.
• Coordinates with other company departments and business partners to ensure effective implementation of the Compliance Program. This, among others, includes performing due diligence of third parties with which the Company will do business.
• Maintains a thorough knowledge of applicable laws, regulations, and enforcement actions to identify emerging risks. Informs the company to new regulations and risks.
• Minimum 10+ years’ experience in global healthcare corporate compliance with in-depth understanding of applicable legal, regulatory, and compliance relevant for the pharmaceutical industry.
• Proven track record of leadership and ability to partner with all relevant team members.
• Demonstrated experience with launching new compliance programs, from creation to implementation.
• Ability to work in a fast-paced environment and handle multiple, conflicting priorities while managing a substantial workload.
• Demonstrated ability to think strategically and also pay close attention to detail.
• Ability to communicate effectively with personnel at all levels of the organization and to generate confidence and support for compliance initiatives.
• Excellent written and verbal communication skills.
• Ability to oversee complex projects and lead them to successful completion in an organized, efficient, and effective manner.
• English speaking and writing skills are required
• Ability to travel as necessary