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Head of North American Compliance
2 months ago
Role Overview
The Head of North American Compliance will be responsible for overseeing and implementing compliance activities in the US and Canada, ensuring adherence to relevant laws, regulations, and industry standards. This role will also involve developing a comprehensive compliance plan with measurable metrics.
Key Responsibilities
- Design, implement, and enforce business rules to ensure compliance with relevant laws, regulations, and industry standards.
- Lead a team of compliance professionals in ensuring the effectiveness of the compliance program, including policy development, training, auditing, and monitoring.
- Continuously mentor and develop a high-performing team.
- Evaluate the compliance function to ensure capacity and competencies to support the organization's growth trajectory.
- Collaborate with global counterparts to ensure synergies between regional and global compliance programs.
- Member of the Canadian Grants, Donations, and Sponsorship Committee, responsible for ensuring process adherence and providing review and approval.
- Analyze proposed grants, market research, and activities engaging US healthcare professionals.
- Oversee capture and reporting of aggregate spend and drug price transparency reporting obligations.
- Serve as a strategic business partner, providing proactive compliance support to designated business areas.
- Contribute to budget planning by developing plans to support compliance business strategy, financials, and organizational structure.
- Chair and manage Canadian Compliance Committee Meetings.
- Provide compliance review of materials submitted for Legal, Medical, and Regulatory Committee review.
- Subject matter expert on privacy for LEO Pharma Canada and local Data Protection Focal Point.
- Review and approve requests for interactions with healthcare professionals.
- Conduct risk assessments on marketing strategies and communicate to management.
- Ensure timely escalation of potential compliance issues to the Vice President, North America Legal and Compliance.
- Lead and assist with internal investigations related to policy violations or the LEO Code of Conduct.
General Requirements
- Ensure compliance with applicable SOPs, policies, and guidelines.
- Complete mandatory training in assigned timelines.
- Participate in personal development and training sessions.
- Work in a safe manner, reporting health and safety concerns.
- Uphold LEO Pharma's core values.
- Execute other duties as required by the Executive team and Management.
Requirements
- Minimum 5 years of experience in a senior-level compliance role in Canada or the US.
- Experience in the life sciences, biotech/pharmaceutical industry.
- Extensive knowledge of Canadian and US Food and Drug regulatory policies.
- Experience leading high-performing teams.
- Ability to influence outcomes with all levels of management and business stakeholders.
- Strong communication and problem-solving skills.
- Business acumen and ability to maintain confidentiality.
- Willingness to extend assistance to other colleagues and departments.
Behavioural Competencies
- Managerial Courage
- Strategic Mindset
- Decision Quality
- Manages Ambiguity
- Communicates Effectively
- Customer Focus
- Plans and Aligns
- Drives Results
- Optimizes Work Processes
- Adaptability
- Collaborates
- Instills Trust
