Compliance Director – N. America
International Pharma Company
Raleigh, NC (home of U.S. office)
We are representing an international pharma company with over a 100-year history in being a leader in their space.
Overview of Compliance Director role:
Support the Chief Compliance Officer in maintaining and overseeing North America Compliance Program. Assist with development and implementation of policies and procedures, auditing and monitoring programs, and developing and delivering training programs. Assist the Chief Compliance Officer in fulfilling all of the Company’s compliance objectives. Train incoming employees.
Support the Compliance Officer
- Provide ongoing leadership, advice and counsel on matters of compliance and ethical business practices to management for compliance issues and process monitoring and improvements
- Work cross-functionally with legal counsel and management, key departments, and committees to ensure that the organization has developed, implemented and trained on all appropriate policies and procedures relating to compliance-related initiatives.
- Assist in the development of periodic reports to the CCO, senior management, the Board of Directors, and Global leadership.
- Deliver compliance training to all new employees during onboarding at the company’s headquarters.
- Provide ongoing support to the Compliance Committee, including programs to educate committee members, corporate assessments, work groups, and other compliance-initiated projects, as needed
- Perform special projects, as needed, to support Compliance initiatives
- Maintain education, awareness, and knowledge of current regulations and best practices in the healthcare industry.
Maintain Compliance Program
- Implement and administer processes designed to maintain compliance with Federal and State laws and regulations on various compliance matters.
- Develop and implement:opolicies and procedures to help address key risk areas;
o training programs (live and web-based) which help to ensure compliance with requirements of the company’s Compliance Program;
o monitoring programs to detect potential instances of non-compliance and to measure performance against compliance obligations.
- Assist with compliance communications to educate employees about key compliance principles and initiatives.
- Conduct risk-based compliance audits of multiple areas of the company’s business, including:oAudit PDMA Sampling compliance (regular randomized audits of sales force; audits for cause)
o Audit sales force expense reports for interactions with healthcare professionals
o Audit medical science liaisons, reimbursement managers, and other medical affairs personnel for compliance with healthcare compliance guide
Investigate Compliance Violations
- Investigate reports of alleged non-compliance to facilitate the development of corrective action plans to improve potential weaknesses and enhance ongoing compliance
- Follow up on audits or reviews generated by the CCO or external advisors or agencies to assist the CCO in prioritizing areas for assessment and audit/review.
- Periodically participate in Internal Audit audits/assessments to conduct tests to identify instances of non-compliance with global/local policies and procedures, and develop recommendations to address the identified issues and control weaknesses.
Training; Communication
- Develop and administer compliance educational sessions; and participate in reporting compliance activities to management.
- Develop educational plans, training materials and resources to educate employees and vendors in the overall objectives of the compliance program and specific substantive areas of compliance for their function/department.
- Maintain a current understanding of regulatory trends and changes in law to advise the CCO and appropriate management staff of trends affecting their activities.
- Provide regular reports to CCO and senior management as requested.
- Manage ongoing release of new hire compliance training, working with online vendors and functional departments as appropriate.
- Enhance and develop further compliance tools and job aids to assist employees across the organization (e.g.,FAQs, quick tips).
Education & Professional Experience:
- Bachelor’s degree; advanced degree preferred
- Minimum five years’ experience in device, pharmaceutical, or healthcare compliance.
- Knowledge of federal fraud and abuse laws, including ACCME guidelines, OIG reports, FDA rules and regulations, and an understanding of the roles and authority of government agencies and industry cooperative groups including FDA, OIG, and PhRMA/Advamed
- Strong project management, interpersonal, planning, organizational and decision-making skills are essential, as is the ability to develop education materials and deliver training, and maintain confidentiality.
Relocation Policy: Full relocation package provided by client
Application Process:
- Send CV in WORD along with current compensation to: maurice@conselium.com
- Compensation range is: $160,000 – $180,000 plus bonus; do not apply if you require more than outlined
