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Compliance Leader

2 months ago

Toronto, Ontario, Canada LEO Pharma Full time

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.