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Head of North American Compliance
2 months ago
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.
Key Responsibilities- Design and implement business rules to ensure Compliance with relevant laws, regulations, and industry standards.
- Lead a team of Compliance professionals in ensuring the elements of an effective Compliance program are met, including implementing necessary policies and procedures, ensuring effective training, and investigating/responding promptly to detected problems.
- Develop and maintain a Compliance plan for the organization with measurable metrics.
- Collaborate with Global counterparts to ensure synergies between Region North America and Global Compliance programs.
- Member of the Canadian Grants, Donations and Sponsorship (GDS) Committee with accountability to ensure process is being followed and provide review and approval together with other committee members.
- 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 across the Region.
- Contribute to the budget planning process 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/Regulatory (LMR) committee review.
- Subject matter expert with respect to privacy for LEO Pharma Canada and local Data Protection Focal Point.
- Review and approve requests for interactions with healthcare professionals.
- Conduct risk assessment on marketing strategies and communicate to management appropriately and in a timely manner.
- Ensure timely escalation of all potential Compliance issues to Vice President, North America Legal & Compliance.
- Lead and assist with internal investigations related to violations of internal policies or the LEO Code of Conduct, as necessary.
- 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 both Canadian and U.S. Food and Drug regulatory policies for the pharmaceutical industries.
- Experience leading high-performing teams of individuals.
- Experience working with all levels of management and consulting with key business stakeholders with an ability to influence outcomes.
- Strong, solution-oriented team player.
- Attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors.
- Possesses strong written and verbal communication skills.
- Embraces LEO core values.
- Business acumen, with ability to maintain confidentiality and identify potential issues.
- Willing to extend assistance to other colleagues and departments.
- Must be able to perform all essential functions of position, with or without reasonable accommodation.
- Managerial Courage
- Strategic Mindset
- Decision Quality
- Manages Ambiguity
- Communicates Effectively
- Customer Focus
- Plans and Aligns
- Drives Results
- Optimizes Work Processes
- Adaptability
- Collaborates
- Instills Trust
At LEO Pharma's Thrombosis Business Unit, we are dedicated to making a global impact in the fight against thrombosis. With over 8 million patients treated annually, we understand the significance of addressing this critical medical need and strive to improve patient outcomes.
Our flat structure empowers you to make a visible impact and offers versatile roles for professional growth. We value diversity and believe that different perspectives, backgrounds, and attitudes contribute to making the best decisions. At LEO Pharma, we encourage you to be yourself and join our passionate team in making a difference.
For certain positions, LEO Pharma might complete a background check conducted by a third party.
