The Senior Director, US Compliance Officer manages critical compliance activities that are integral to the development, implementation and execution of the US Compliance and Ethics program, called I-CARE, to ensure corporate compliance with US legal requirements and industry codes of practice. An inspiring and engaging leader is sought to manage the US I-CARE team, work with senior leadership, and help lead the program throughout the organization. This position is not responsible for GxP compliance. We are looking for enthusiastic and talented individuals who thrive on challenge and change, and who want to make a difference through the delivery of results.
Enhance, implement and maintain the US portion of the I-CARE Program, especially in respect to US Healthcare Compliance to promote an environment of compliance, integrity and ethical standards. Includes the development of initiatives, policies, and procedures and trainings.
Work with primarily US commercial and medical teams to develop, implement, review and update compliance policies and procedures.
Provide leadership/guidance for resolution of issues and ensures issues are investigated promptly and according to established procedures.
Ensure that initial and ongoing training/education is provided to staff on compliance issues to contribute to a thorough understanding.
Ensure processes are in place for reporting, documenting, investigating and responding to compliance incidents.
Ensure that specialized training is provided in departments where documentation indicates a trend or pattern of non-compliance.
Oversee periodic monitoring/auditing activities to ensure on-going compliance and to assess for improvement of processes.
Providing metrics and represent US Compliance Committee at Global Compliance Committee meetings.
Monitor compliance activities and incident statistics for completion, and potential areas of risk.
Conduct assessments of existing practices; develop standards and procedures to support compliance.
Identify needs and opportunities, makes recommendations and works effectively and tactfully to correct deficiencies.
Assist the Global CCEO to oversee the development of the global I-CARE program, policies & trainings; the development of consistent, value-added, and timely information sharing or dialog about compliance initiatives to ensure effective operations, effective working relationships, and informed and engaged employees.
Serve as a leader and role model in support of GW’s I-CARE program for Corporate Compliance and Business Integrity, demonstrating Compliance, Accountability, Respect and Ethical behavior.
Bachelor’s degree, combined with 10-15 years of experience in the pharmaceuticals or life sciences industry encompassing 5-15 years of compliance experience in progressively responsible roles. JD or equivalent legal qualification required.
CCEP, HCCA, or Seton Hall Healthcare Compliance or similar certification or Masters degree in corporate, healthcare and/or pharmaceutical compliance preferred.
Proven leadership skills in developing, directing, organizing, managing, coordinating and monitoring complex processes.
Experience leading, inspiring and developing teams.
Ability to manage organizational change, problem solve, make and implement high impact decisions.
Excellent analytical skills, including the ability to discern the nature of the problems presented and the practical application of regulatory and ethical requirements.
Good written and verbal communication skills to influence others and initiate change.
Ability to work well between functions and across all levels of the business.
Good working knowledge of personal computers and office software (Word processing, spreadsheets, databases, and presentation packages).
Demonstrated ability and willingness to learn and apply new and upgraded systems to job responsibilities.
Ability to build consensus, and influence without authority to produce effective work results with a minimum of confusion; practices courtesy, tact and honesty in all internal and external work relationships.
Demonstrated success utilizing a variety of communication tools, from verbal communication to the use of current technology, one-to-one interactions and the facilitation of small group work sessions to company-wide distributions.
GW has established a world leading position in the development of plant-derived cannabinoid therapeutics through its proven drug discovery and development processes, intellectual property portfolio and regulatory and manufacturing expertise.
Company size: 900
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