Compliance Leader
2 weeks ago
Role Overview
The Head of North American Compliance is a key strategic and hands-on role at LEO Pharma, overseeing day-to-day compliance activities in the US and Canada. This position involves developing a comprehensive compliance plan with measurable metrics and leading a team of compliance professionals.
Key Responsibilities
- Designing, implementing, and enforcing business rules to ensure compliance with relevant laws, regulations, and industry standards.
- Leading a team to ensure an effective compliance program, including implementing policies and procedures, training, auditing, and monitoring.
- Mentoring and developing a high-performing team.
- Evaluating the compliance function's capacity and competencies to support the organization's growth trajectory.
- Collaborating with global counterparts to ensure synergies between Region North America and Global Compliance programs.
- Analyzing proposed grants, market research, and activities engaging US healthcare professionals.
- Overseeing aggregate spend and drug price transparency reporting obligations.
- Serving as a strategic business partner providing proactive compliance support to designated business areas across the Region.
- Contributing to budget planning by developing plans to support compliance business strategy, financials, and organizational structure.
- Chairing and managing Canadian Compliance Committee Meetings.
- Providing compliance review of materials submitted for Legal/Medical/Regulatory (LMR) committee review.
- Subject matter expert on privacy for LEO Pharma Canada and local Data Protection Focal Point.
- Reviewing and approving requests for interactions with healthcare professionals.
- Conducting risk assessments on marketing strategies and communicating to management appropriately.
- Ensuring timely escalation of potential compliance issues to Vice President, North America Legal & Compliance.
General Requirements
- Ensuring compliance with SOPs, policies, and guidelines applicable to the role.
- Completing mandatory training upon hire and when new or revised policies are issued.
- Participating in personal development and training sessions as required.
- Working safely and reporting health and safety concerns.
- Consistently upholding LEO Pharma's core values.
Requirements
- 8+ years in a senior-level compliance role in Canada or the US.
- Experience in the life sciences, biotech/pharmaceutical industry.
- Extensive knowledge of Canadian and U.S. Food and Drug regulatory policies.
- Experience leading high-performing teams.
- Strong written and verbal communication skills.
- Business acumen with ability to maintain confidentiality.
- Willingsness to extend assistance to other colleagues and departments.
Beyond the Skin
At LEO Pharma's Thrombosis Business Unit, we address the critical medical need of thrombosis, treating over 8 million patients annually. Our flat structure empowers you to make a visible impact and offers versatile roles for professional growth. We value diversity and believe different perspectives contribute to making the best decisions. Join us in making a difference.
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