Head of Compliance, NA
International Pharmaceutical Company
Inselin, New Jersey
We are representing a small and profitable international pharmaceutical company that is experiencing revenue growth; growth projections include 500% cumulative revenue growth the next 4 years. We have a robust product pipeline and a solid delivery system inclusive of operating in 190 global markets.
Why Join Us:
- We are privately held so our strategic vision is well conceived and not short term
- We have a robust product pipeline
- Our senior management team are proven performers from sophisticated pharma companies
- You will report directly to the CEO of NA with a dotted line to the CCO in Switzerland
- You will be afforded great autonomy to continue the development/enhancement of our compliance program
Head of Compliance, NA – 1st Year Expectations:
- Establish trusted relationships with all key stakeholders
- Conduct a risk assessment to establish baseline of the compliance program
- Consistently enhance the program and have operating management own their contribution to the program
Head of Compliance, NA Responsibilities:
- Create an environment where the Compliance team is seen as a resource and operations evaluates risk in the decision-making processes
- Identify compliance risks and establish a mechanism to mitigate the risks and ensure compliance across the organization.
- Manage the Compliance Training learning management system which includes developing content, ensuring all employees are assigned and complete required training. Conduct live compliance training and awareness activities for employees and business partners.
- Assist with the annual certification of the company’s Code of Conduct.
- Serve as Chairperson for the quarterly Compliance Working Group Meeting.
- Serve as a resource as member of the Promotional Review Committee
- Manage the annual auditing and monitoring plan and then conduct various auditing and monitoring activities in accordance with the plan.
- Review relevant internal processes, policies, and procedures, identify gaps, and suggest changes and/or improvements.
- Monitor 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.
- Supervise the Manager of Compliance
Head of Compliance, NA Responsibilities:
- Education: Bachelor’s Degree required… advanced degree preferred
- Industry experience: Must have experience in pharma, biotech or medical devices
- Functional experience: In-house experience in compliance department or in-house legal department that provides counsel to compliance department or directly to business operations. Experience working on Commercial and Medical & Scientific Affairs compliance issues.
- Regulatory knowledge: Knowledge of pharmaceutical industry laws, regulations, and guidelines, including: anti-corruption, customer/patient interactions, conducting internal investigations, Foreign Corrupt Practices Act, Federal Anti-Kickback, HIPAA, False Claims Act, Off-Label Promotion, Sunshine Act, privacy and data protection
- Prior supervisory experience is a plus.
Head of Compliance, NA Application Process:
- Send CV as WORD document
- Provide required base salary, bonus, LTIC
- Send information to: maurice@conselium.com
