Head of Ethics & Compliance US

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.

SUMMARY OF POSITION

The Head of Ethics & Compliance US will partner with the Chief Compliance & Risk Officer to ensure that the company’s US compliance program is designed to meet the requirements of laws and regulations within the US. More specifically, the Head of Ethics & Compliance US will work with the global compliance team to develop the company’s global risk assessment and mitigation plan, develop and implement policies and procedures that promote adherence to US legal requirements, as well as to provide day-to-day counseling and needs assessment reviews to ensure compliant US business activities.The Head of Ethics & Compliance US will report to the Chief Compliance & Risk Officer, be a member of the United States Leadership Team (USLT), and be a key contributor to the structure, content, and success of the global compliance program. In addition to the foregoing, this role will have responsibility for the activities and responsibilities set forth below.

MAJOR ACTIVITIES AND RESPONSIBILITIES

•Partner with the Chief Compliance & Risk Officer to develop, implement, and manage compliance program strategy for the US business.

•Provide day-to-day advice and support on local laws governing US commercial operations, medical affairs, clinical trials, data privacy, interactions with health care professionals and patients, and related matters.

•Partner with relevant compliance department staff to develop, implement, and train commercial, medical, patient and professional advocacy, program management, and R&D staff on applicable compliance policies, procedures, laws, regulations, and guidelines (including but not limited to the company’s code of conduct; PhRMA Code; anti-corruption laws including the FCPA, and other applicable anti-corruption laws; pharmaceutical marketing regulations; privacy laws; and transparency laws).

•Partner with the EU Data Privacy Officer to implement the Amicus global data protection program in the US, ensure adherence to data privacy laws in the US, and provide expert advice and guidance. Work with the business to ensure compliance with relevant regulations including the California Privacy Act, and where applicable the GDPR.

•Partner with Head of Transparency in developing systems and processes for complying with Sunshine Act and state law reporting requirements and working with the business to timely and properly collect and report payment data pursuant to those laws.

•Partner with the Head of Monitoring & Auditing to develop and implement the global compliance monitoring and auditing plan, including helping to manage third party compliance as applicable.

•Support/conduct US-related compliance investigations as applicable.

•Lead the US Compliance Committee, and provide updates to the Global Risk Committee as needed.

•Meticulously document all US compliance records, including without limitation training presentations/records and business activity reviews, into the company’s Compliance Records Management System.

•Keep abreast of US legal developments, including applicable new laws, regulations, guidances, industry trends, and case law.Update the Chief Compliance & Risk Officer, relevant compliance department staff, and the Global Risk Committee regarding such legal developments, and help update the global compliance program as necessary.

•Work with the Chief Compliance & Risk Officer and the USLT to foster a company-wide culture of compliance to safeguard the company’s reputation as an ethical and trustworthy business partner and supplier of high-quality medicines to the public, and reduce the risk of governmental investigations, fines, and other sanctions.

•Conduct Compliance onboarding training for on the Anti-Bribery Policy and Code of Conduct for new US hires. This position will also train all management level new hires on Integrity Leadership and the ACE (Amicus Compliance Engine). Update training as needed and maintain training records in Compliance Management System.

ORGANIZATIONAL STRUCTURE

Reports to Chief Compliance & Risk Officer

QUALIFICATIONS AND BACKGROUND REQUIREMENTS

Educational Requirements

•JD not required, but preferred.

Professional Work Experience

•10-15 years cumulative compliance and/or legal experience in the pharmaceutical industry.

•In-depth knowledge, understanding, and experience with PhRMA Code, OIG guidance, US commercial compliance laws, regulations, and guidelines are a pre-requisite.

•Strong attention to detail (self-motivated to continuously build and maintain an up-to-date and best-in-class compliance program).

•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.

•Excellent written, verbal, and organizational skills.

•Meticulous documenter.

•Fluent English, with additional languages a plus.

Location

This position will be based in Princeton, NJ.

Travel

0%-5%

We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.Our unique experiences, backgrounds and range of cultural perspectives enrich how we approach opportunities, pushing ideas as far and as fast as possible with patients always our top priority. Employee expertise, intelligence, and creativity drives our innovation, and our passion and commitment to excellence.Our “Three Pillars of DEI” are interwoven into our Amicus culture and expands one person, one word, and one act at a time. For our employees, these three pillars are a touchstone for inspiration, guidance, and encouragement.

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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