Head of North American Compliance

4 weeks ago


Toronto, Ontario, Canada LEO Pharma Full time

Role Description

The Head of North American Compliance will oversee the day-to-day operations of Compliance activities in the US and Canada, developing a Compliance plan with measurable metrics. This role requires a strategic and hands-on approach, ensuring compliance with relevant laws, regulations, and industry standards.

  • Design, implement, and enforce business rules to ensure compliance.
  • Lead a team of Compliance professionals in ensuring an effective compliance program.
  • Mentor and develop a high-performing team.
  • Evaluate the Compliance function to ensure capacity and competencies.
  • Collaborate with Global counterparts to ensure synergies between Region North America and Global Compliance programs.
  • Member of the Canadian Grants, Donations, and Sponsorship Committee.
  • 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.
  • Contribute to the budget planning process.
  • Chair and manage Canadian Compliance Committee Meetings.
  • Provide Compliance review of materials submitted for Legal/Medical/Regulatory 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.
  • Ensure timely escalation of all potential Compliance issues.
  • Lead and assist with internal investigations.

General

  • Ensure compliance with appropriate SOPs, policies, and guidelines.
  • Complete mandatory training in assigned timelines.
  • Participate in personal development and training sessions.
  • Work in a safe manner that does not endanger yourself or co-workers.
  • Strive to consistently uphold LEO Pharma's core values.
  • Execute other duties as required by Executive team members and other members of LEO Pharma's Management team.

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 both Canadian and U.S. Food and Drug regulatory policies.
  • Experience leading high-performing teams.
  • Experience working with all levels of management and consulting with key business stakeholders.
  • Strong, solution-oriented team player.
  • Attention to detail and ability to work individually and within a team.
  • 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 the position, with or without reasonable accommodation.

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

Beyond the Skin

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.



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