We are representing a global pre-commercial pharmaceutical company in their search for a Chief Compliance Officer.
Why Join Us:
- Opportunity to build the compliance program in a well-invested late-stage pharmaceutical enterprise
- Working alongside an established executive team, many of whom coming from large global pharma backgrounds
- Full support will be provided in the development of a robust and technically advanced program
Expectations first 12 months:
- Develop collaborative relationships with other members of the Executive Team as well as the Board of Directors, establishing clear goals and timelines
- Conduct enterprise-wide risk assessment and develop then implement a plan to roll out full compliance program
- Work with commercial teams and other stakeholders on a compliance program plan for post-commercial business
Responsibilities:
- Reporting to the General Counsel / Chief Operating Officer with a dotted line to the Board of Directors, you will be responsible for will creating and implementing the compliance function with an effective and integrated compliance program to prevent illegal, unethical, or improper conduct; In particular, the Chief Compliance Officer shall develop and implement policies and procedures to ensure compliance with rules and regulations that are applicable to commercial healthcare companies such as OIG, PhRMA Code, DOJ, and HIPPAA
- In consultation with various other leaders, implement and maintain an effective compliance program that prevents illegal, unethical, or improper conduct company-wide; Work with commercial partner(s) to ensure that the compliance program meets the needs of the partnership(s)
- Develop and implement policies and procedures to ensure compliance with federal and state regulatory rules and regulations governing commercial matters such as drug promotion, gifts, consultants, grants, physician interactions, symposiums, CME and publications
- Create and implement a company-wide training program that adequately and effectively trains employees on the compliance program and appropriately introduces the compliance program to new employees
- Interact with the Board and the Committees of the Board to ensure that all are adequately informed on the Company’s compliance matters
- Assist in managing litigations and investigations related to the Company’s compliance program
- Revise and implement privacy policies for the Company as domestic and international regulations evolve
- Respond to and address alleged violations of rules, regulations, policies and procedures by assisting in investigations, informing executive management and the Board and recommending the necessary actions to prevent further violation
- Continue to monitor the state, federal and international legislative landscape to stay informed on proposed laws, rules and regulations that the Company must follow. Review and interpret the proposed or new laws, rules and regulations and provide frequent updates and summaries to executive management and the Board on proposed or new rules and regulations
- Establish and chair a compliance committee that includes the CEO, General Counsel, Chief Financial Officer, SVP of Regulatory, SVP of Marketing and Vice President of Quality to periodically evaluate the effectiveness of the Company’s compliance program and any alleged violations of such program
- Be a member of the Quality Leadership Team
- Ensure proper reporting of violations to duly authorized enforcement agencies as appropriate or required
Qualifications:
- Essential Education: Bachelor’s Degree
- Significant executive level pharmaceutical compliance experience, with demonstrable exposure to building and significantly improving compliance programs
Application Process for Chief Compliance Officer: Qualified professionals are to submit resume to Steve Harrison: steve@conselium.com
Published by Conselium Executive Search, the global leader in compliance search.
