Head of North American Compliance

7 months ago

Toronto, Canada LEO Pharma Full time
Role Description

Position Objective: 

The Head of North American Compliance is a highly visable, strategic and hands-on role. The individual in this role will be responsible for the day-to-day oversight and operations of Compliance activities in the US and Canada, as well as developing a Compliance plan for the organization with measurable metrics.

 

Role & Resposnsibilities:

 

  • Designing, implementing, overseeing, and enforcing business rules to ensure compliance with relevant laws, regulations, and industry standards.

  • Leading team of Compliance professionals in ensuring the elements of an effective compliance program are met, including implementing necessary policies and procedures, ensuring effective training, ensuring a robust auditing and monitoring program is in place, and investigating/responding promptly to detected problems.

  • Continuously mentoring and developing a high-performing team.

  • Evaluating the Compliance function to ensure 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.

  • 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.

  • Analyzing proposed grants, market research, and activities engaging US healthcare professionals.

  • Overseeing capture and reporting of 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 the budget planning process 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 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. 

 

​​​​​​​General: 

  • Ensure compliance with appropriate SOP’s, policies and guidelines applicable to role.

  • Complete mandatory training in assigned timelines upon hire as well as when new or revised policies, SOP's, guidance’s are issued.

  • Participate in personal development and training sessions as required for the position.

  • Work in a safe manner that does not endanger yourself or co-workers.  Report any health or safety concerns (internal and external) in compliance with LEO Pharma policy and standard procedures.

  • Strive to consistently uphold LEO Pharma’s core values. 

  • Execute other duties as may be required by Executive team members and other members of LEO Pharma’s Management team as training and experience allow.

 

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 for the pharmaceutical industries

  • Experience leading high-performing team 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.


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.

Join us on our journey Beyond the Skin. Apply today
 

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