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Hybrid Senior Director, Global Compliance Policies, Training, and High-Risk Third Party Management en Amicus Therapeutics

Amicus Therapeutics · Princeton, Estados Unidos De América · Hybrid

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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 independently and collaboratively in a matrix environment.
  • Strong business partner with demonstrated experience in collaborating with a team of multi-cultural professionals.
  • Strong problem-solving skills.
  • Ability to accurately document programs and outputs.
  • Fluent English, with additional languages a plus.


    • Other Skills/Attributes
  • Demonstrated alignment with Amicus Mission Focus Behaviors
  • Passion for rare disease and patient focused


    • Travel
  • 10%


    • We value an inclusive environment where individual experiences and perspectives are celebrated, and voices from the rare disease community are heard.
     
    Amicus is an equal opportunity employer and will judge all applicants based on their qualifications for the job, without regard to race, color, sex, religion, national origin, age, disability, sexual orientation, gender identity, protected veteran, disability status or any other characteristics protected by applicable federal, state or local law.
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