Audit & Compliance

hace 2 semanas

Madrid, Madrid, España LEO Pharma A tiempo completo

Field of work:

Legal, Audit & Compliance
Posting Date:22 Nov 2023
Application deadline:

Location:
Canada, , Canada

Contract type:
Permanent

Job ID: 1691Role Description

  • Position Objective:
  • The Canada General Counsel & Executive Director of North American Compliance is a highly visible, strategic, and hands-on role. The individual in this role will be responsible for day-to-day oversight of Compliance activities in the US and Canada, as well as developing a Compliance plan for the organization with measurable metrics. The individual in this role will also be responsible for providing legal advice to the Canadian Senior Leadership team, as required, and will act as the Privacy Officer for the Canadian affiliate.
  • Role and Responsibilities:
  • 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.
  • Evaluating the Compliance function to ensure capacity and competencies to support the organization's growth trajectory.
  • Continuously mentoring and developing a highperforming team.
  • 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 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.
  • Chair and manage Canadian Compliance Committee Meetings
  • Actively represent Legal perspective regarding Advertising/Promotion in Legal/Medical/Regulatory (LMR) meetings
  • 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
  • Review amd 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
  • Assist with internal investigations related to violations of internal policies or the LEO Code of Conduct, as necessary
  • Provide Canadian affiliate with legal support, including but not limited to;
  • Counsel and train stakeholders on relevant laws and regulations related to promotional activities, product labeling, and marketing strategies in Canada
  • Provide guidance on appropriate prelaunch and launch activities for various LEO Pharma products in any point of the development lifecycle
  • Review and provide legal advice on advertising and promotional materials, training materials, press releases and similar pieces
  • Provide legal advice for LEO Affiliates engaging in activities in Canada
  • Draft, review, and negotiate contracts, as necessary
  • Maintain awareness of relevant laws and regulations, keeping abreast of current changes that may affect the organization
  • Conduct any necessary due diligence
  • 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 coworkers. 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:
  • JD or LLB and in good standing with the Law Society of Ontario (or other provincial bar);
  • LLM or DCL an asset;
  • 8+ years in a seniorlevel 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
  • Minimum 10 years in the pharmaceutical industry
  • Demonstrated ability leading cross functional, highperforming teams.
  • Experience working with all levels of management and consulting with key business stakeholders with an ability to influence outcomes

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