Description Responsibilities
- Responsible for overseeing all elements of Helsinn's comprehensive compliance program, managing all compliance matters pertaining to the U.S. organization and working on complex compliance matters that impact the success of the company's products and/or future technologies, in coordination with Helsinn Group's Global Compliance Officer.
- Develop and assess key performance indicators to evaluate effectiveness of HTU's compliance program.
- Draft and perform periodic reviews of compliance policies and procedures in accordance with applicable legal, regulatory and industry standards.
- Manage annual auditing and monitoring plan. Prepare reports based on the observations of such reviews.
- Develop content for and conduct compliance training to HTU personnel and vendors.
- Develop tools and mechanisms for effective lines of communications relating to compliance matters.
- Manage learning management system.
- Track and monitor all federal and state laws and regulations governing transparency reporting and disclosures and ensure that all filings are correctly prepared and filed.
- Develop and implement annual monitoring plan of HTU's activities based on risk-based approach.
- Work with Legal and Human Resources as well as Helsinn Group Compliance in performing compliance investigations, responding to detected compliance violations, and undertaking corrective action.
- Work with Legal and Helsinn Group Compliance in performing risk assessments and conducting audits of HTU activities.
- Collaborate with US leadership (Legal, Sales, Marketing, Medical & Scientific Affairs, and Human Resources) on compliance matters to ensure compliance with laws, regulations, and industry guidelines and best practices, and Company Code of Conduct and policies.
- Create and support an environment through, among other things, policies, procedures, education, monitoring, and communications, where consideration is given to compliance with all appropriate laws and guidelines in all HTU activities.
- Supervise the Manager of Compliance Operations.
- Serve as an ad-hoc member of the Promotional Review Committee (PRC), to address compliance related questions.
- Monitor federal and state laws, regulations and guidance, industry developments, and the external environment to ensure the implementation of external best practices as well as to respond to future business, ethics and compliance developments.
- Manage all external Compliance vendors and the Compliance annual budget.
- Incumbent will develop relationships with key stakeholders, working closely with HTU colleagues.
- Incumbent will assess and advise on HTU's compliance needs and will be instrumental in continuing to build HTU's compliance department, policies and practices.
- Incumbent will be responsible for monitoring and complying with all federal and state law marketing and transparency disclosure and reporting requirements.
Work Experience
- Minimum of 7 years of compliance experience either in-house or as a consultant within a pharmaceutical or biotech company with demonstrated knowledge and experience developing and managing comprehensive compliance programs, including supporting and providing compliance guidance to commercial and medical and scientific affairs departments. Prior supervisory experience is a plus.
- In depth knowledge of pharmaceutical industry laws, regulations, and guidelines, including federal Antikickback Statute, federal and state False Claims Act, FDA statutes, regulations, and guidance governing pharmaceutical promotional activities, laws and regulations governing federal healthcare programs, federal and state sunshine laws and regulations and transparency reporting requirements, federal and state laws and guidance governing interactions with healthcare professionals, including PhRMA Code. Experience complying with state privacy and data protection laws is a plus.
- Proficiency with handling and analyzing data.
- Ability to work in an international environment.
- Ability to travel 10-15%.
- Strong interpersonal, written and verbal communication skills.
- Skilled educator, including the ability to teach complex and/or technical material.
- MS Office suite proficiency.
Education: Bachelor's Degree required. Master of Jurisprudence, post-graduate certificate in Healthcare Corporate Compliance, and/or J.D. degree preferred.