Director Integrity & Compliance / USL Commercial Chief Compliance Officer

About the position

Ensuring enterprise compliance is a core mission of the Company. The Director of USL Integrity & Commercial Compliance / COO has primary responsibility for oversight and management of the Company's U.S.-based commercial compliance program. Core activities include the development, implementation and oversight of commercial compliance policies; the conduct of compliance risk assessment analyses and routine monitoring; regular reporting and the provision of independent advice and direction to the management team members and the Company; development of compliance education and training; investigating instances of alleged misconduct; and ongoing monitoring of the U.S. commercial compliance environment. This position oversees and manages, directly and/or through other members of the commercial compliance department including budgeting and interactions with outside compliance counsel. This position is also responsible for leading, managing and mentoring of other members of the Commercial Compliance Department.

Responsibilities

• Recognize and anticipate key business compliance issues and risk and communicate to the appropriate Company leadership the nature and potential impact of such issues and risks, and potential approaches and strategies to mitigate or remediate identified risks.
• Establish strong relationships with key internal stakeholders to understand current and future compliance needs.
• Maintain a current working knowledge of various laws, regulations and industry guidance that affect the Commercial Compliance program including Medicare/Medicaid, Food, Drug, and Cosmetic Act, Drug Supply Chain Security Act, Prescription Drug Marketing Act, Sunshine Laws, and other applicable state and federal laws, regulations and industry guidelines applicable to the Company and its Affiliates.
• Manage and supervise the work of the Commercial Compliance team in developing health care compliance policies and other Commercial Compliance policies, including through development of training and processes for monitoring and auditing compliance.
• Serve as the primary point of contact for commercial compliance investigations, inquiries and audits.
• Work with and support other Commercial Compliance team members' work with inter-departmental management to increase legal, compliance and regulatory awareness and encourage open lines of communication regarding compliance concerns.
• Prepare and monitor the budget of Commercial Compliance and quarterly revisions thereto as necessary.
• Oversee compliance aspects of pharmaceutical and biosimilar product launches including review of market access agreements and advise on development of patient assistance programs.
• Work with outside counsel when necessary and appropriate.
• Other duties as assigned.

Requirements

• Minimum of 10 years in a compliance role; preferably in a corporate US Pharmaceutical business.
• A Juris Doctor degree from an accredited law school prior to 2015. Preference for a graduate in the top 20% of the law school class.
• A minimum of 5 years in-house compliance or equivalent law firm experience, preferably a minimum of 5 years Commercial Compliance experience in the medtech, healthcare, or most preferably pharmaceutical industry.
• Strong training and presentation skills and experience.
• Proven ability to partner well with cross-functional business leaders.

Nice-to-haves

• Knowledge and ability to understand and apply laws and regulations.
• Legal writing skills.
• Ability to analyze a situation and generate solutions.
• Knowledge of pharmaceutical advertising concepts.
• Knowledge of the pharmaceutical and healthcare industry.
• Skilled at employee training and leadership.
• Ability to work independently or in a team.
• Ability to perform detailed work.
• Strong interpersonal skills required.