Amicus Therapeutics, Inc. Cranbury , NJ 08570
Senior Manager, Global Compliance Auditing & Monitoring
The Amicus Compliance and Risk Management Department is looking to hire an individual to participate in the Global Compliance Auditing and Monitoring strategic evolution. This individual's primary responsibilities will be to assist the Senior Director, Global Auditing, Monitoring, and ERM with: 1.) independently executing and prospectively managing the global elements of the auditing and monitoring activities as identified through the annual planning process, and 2.) managing and executing the global high-risk third party program.
Listed below are the top line responsibilities for the Senior Manager, Global Compliance Auditing and Monitoring:
Update and refresh the global Compliance Risk Assessment
e.g., Commercial, Medical, Patient Advocacy, High Risk 3rd Parties (HR3P)
Update and refine the global A&M strategy based on experience and new additions
Develop and adjust the annual A&M plan including individual work programs / checklists
Execute the A&M plan
This individual will collaborate with all members of the compliance function, and employees throughout the company, to help drive and ensure the timely completion of all Compliance Auditing, and Monitoring activities.
Roles and Responsibilities
The Senior Manager, Global Compliance Auditing and Monitoring will assist the Senior Director, Global Auditing, Monitoring, and ERM with the following:
Compliance Risk Assessment: Preparation and continuous improvement of the global annual Compliance Risk Assessment Process. Ensure a right-sized and prospective risk-based methodology to assist management in identifying, qualifying, quantifying and prioritizing the company's Compliance risk areas. Leverage historical experiences and changes in global enforcement trends and market nuances to develop a leading edge, fit for purpose assessment. Communicate annually the output from this formalized risk assessment to key global stakeholders.
Compliance Auditing & Monitoring Plan: Through the strategic use of internal and external resources, oversee the operation and successful completion of the annual Compliance Auditing & Monitoring Plan. Create an annual Compliance Auditing & Monitoring Plan, using the results derived from the Compliance Risk Assessment to identify and prioritize those areas of compliance-related risk that require auditing and/or monitoring activities. Periodically review and update the Plan to reflect changes in external focus and/or company programs/functions. The scope of the Plan shall include, but not be limited to, reviews of global commercial, medical, and patient advocacy activities, events, and payments that are subject to Amicus compliance policies.
Auditing and Monitoring Workprogram Development and Execution: Prepare a top line annual workplan and utilize the company's written compliance standards as a basis to develop and implement detailed, effective auditing and monitoring tools (i.e., individual workprograms, checklists, questionnaires, etc.) designed to assess compliance with specific company standards. Activities subject to auditing and monitoring include for example HCP field interactions through ride alongs, speaker programs, and advisory boards. Leverage available guidance and determine appropriate test sample sizes that aligns the "rare disease" environment and is scalable to Amicus' growth. Identify the potential root causes for areas where non-compliance is discovered. Account within each plan year for updates and changes in regulatory guidance issued by the OIG and/or DOJ regarding compliance effectiveness as well as information obtained from the most recent corporate integrity agreements. Manage the quarterly identification and selection of test samples and coordinate with Finance and Legal to obtain all supporting documentation to complete required testing each quarter. Summarize results for audit and compliance committee reports.
High Risk Third Party (HR3P) Program: Oversee the launch, operation and successful completion of an annual HR3P process including the annual auditing and monitoring activities and contracting requirements associated with strong oversight of HR3Ps. Maintain ownership of the master HR3P inventory by vendor type and execute continuous oversight and evaluation of preventative (screening and diligence) and detective (monitoring and auditing) controls designed and placed in operation 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. Ensure front end and back end policies and procedures related to HR3Ps continue to operate as designed and periodically test for operating effectiveness via the annual auditing and monitoring plan. Ensure any system based processes contain the appropriate controls and align with established policies and procedures. Ensure the HR3P program evolves to capture the latest trends and activities based on changes in enforcement and recent case law. Maintain the HR3P program as a best-in-class, leading edge business process and leverage where possible, other business controls.
Issue Remediation: In areas where the auditing and monitoring / HR3P Programs disclose instances of non-compliance, identify the potential root causes and work with management to tailor remediation to the specific root cause(s) of the non-compliance. Identify and recommend remedies to remediate (i.e., enhanced controls, re-training, etc.), and monitor the progress and status of recommended remediation activities.
Internal Controls: In those instances where auditing and monitoring identifies systemic non-compliance, work with management to establish and/or enhance internal controls and training designed to minimize the risk of non-compliance.
Reporting: Prepare and deliver periodic reports to the Senior Director, Global Auditing, Monitoring and ERM and the Chief Compliance & Risk Officer on the status of global auditing & monitoring activities, the results of individual auditing and monitoring initiatives, and the status of remediation activities on prior identified areas of non-compliance.
Minimum of bachelor's degree. Additional health law certificate preferred.
Minimum of 5-7 years combined in-house pharmaceutical compliance experience and internal audit experience. Prior compliance field monitoring experience a requirement.
Demonstrated ability to go deep and understand the nuances of a product's approved label (e.g., what clinical data is in the label, what data is consistent with the label, and what data is neither in the label nor consistent with it).
Strong working knowledge of US and International pharmaceutical laws, regulations and guidance, such as US federal and state anti-kickback laws, international prohibitions against off-label promotion, US Foreign Corrupt Practices Act, UK Bribery Act, so can guide the business and explain the "why" behind Amicus policies and training.
Perfectionist with strong attention to detail (self-motivated to continuously build and maintain an up-to-date and best-in-class compliance auditing and monitoring program).
Excellent written, verbal and organizational skills (ability to effectively work with and communicate, both orally and in writing, across all functions and regions).
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.
Strong business partner with demonstrated experience in collaborating with a team of multi-cultural professionals.
Strong problem-solving skills.
Fluent English, with additional languages a plus.