Senior Director, Global Compliance Policies, Training, and High-Risk Third Party Management

Amicus Therapeutics is a global, patient-dedicated biotechnology company focused on discovering, developing, and delivering high-quality medicines for people living with rare metabolic diseases.

Position Summary
The Senior Director of Policy, Training, and High-Risk Third-Party Management will report to the Chief Risk Officer, but closely support the US and International Business Partners in a matrix environment. This role will be responsible for enhancing and driving 4 critical areas within the Compliance Program:· Policy Management· Training Strategy and Implementation· High-Risk Third-Party Operations· Compliance Operations

Roles and Responsiblities

• Serve as the ‘owner’ of Amicus’ global compliance policies, SOPs, and other similar types of documents
• Establish policy governance and evolve policy architecture for the department (e.g., simplifying policy structure, number of policies)
• Participate in the yearly risk assessment process to ensure that Amicus policies cover the risks identified in the assessment
• Collaborate with the US, International, and Data Privacy business partners, and across the Compliance team as appropriate, to create and/update policies (e.g., new activities, law/code/regulation updates, updates based on audit findings)
• Identify language translation needs and coordinate translations as needed
• Ensure policies are promptly posted to the company intranet
• Create a strategic annual training plan aligned to Policy Management, risks, and business needs
• Collaborate with the US, International, and Data Privacy Business Partners, and across the Compliance team as appropriate, to create training materials deployed to the functions/geographies, including new hire onboarding, functional training (e.g., sales, medical, Patient Advocacy) and topic specific training (e.g., antibribery and corruption, hiring HCPs for services, etc.)
• Leverage instructional design skills to deliver training in a fun but meaningful way, measuring comprehension, and tracking attendance/completion of training
• Provide consistent, reliable, and accurate reporting on the state of compliance training activities to the Chief Risk Officer and the US, International, and Data Privacy Business Partners
• Meticulously document all training plans, presentations, and acknowledgements in the company’s compliance records management system
• HR3Ps include distributors, event planners, travel agents, regulatory consultants, and the like
• Participate in the annual global Compliance Risk Assessment Process relating to HR3Ps
• Manage the operations of the program, including the use of preventative (screening and diligence), contractual (leveraging Legal), and detective controls (leveraging the Compliance Monitoring and Auditing team) to mitigate risk
• Hold monthly meetings with Legal and Finance to reconcile and ensure the proper identification, classification, and tracking of HR3P vendors and associated contracts.
• Partner with the International Business Partner across markets as needed (e.g., new distributors in new geographies)
• Manage policies and procedures related to HR3Ps, update as needed, conduct training internally and externally and periodically test for operating effectiveness via the annual auditing and monitoring plan
• Facilitate HR3P Issue Remediation by collaborating with the International Business Partner, Legal, and the business to assess the issue, root cause and mitigation plans
• Prepare and deliver periodic reports to the Chief Risk Officer and others as identified on all aspects of the global HR3P Program, from diligence to continuous oversight
• Support the Compliance team to timely track and close out objectives

Educational Requirements

• Minimum of Bachelor’s degree.
• Additional health law certificate preferred.

Professional Work Experience Requirements

• Minimum of 8-10 years in-house pharmaceutical, biotech, or medical device experience within the corporate compliance function
• Experience in both US and international compliance is preferred

Experience and Skills

• Well-rounded expertise across the Elements of a Compliance Program including policy management, training, third party due diligence or other related areas
• Strong attention to detail (self-motivated to continuously build and maintain an up-to-date and best-in-class compliance program).
• Excellent written, verbal and organizational skills (ability to effectively work with and communicate, both orally and in writing, across all functions and regions).
• Expertise in PowerPoint
• Project management skills (can timely perform, track, and oversee projects with high attention to detail and little oversight).
• Ability to work both independe