Compliance Specialist

Type: Permanent - Full time
Location: Montreal - Head Office
Department: Legal Affairs & Compliance
Summary of Purpose:

The Compliance Specialist will be a key partner working with all functions of the organization to ensure that Otsuka Canada Pharmaceutical Inc.’s (“OCPI”) operations and processes are aligned with our SOPs, policies and procedures and the effectiveness of our compliance program. To this end, the Specialist will participate in the continuous improvement of compliance processes, the planning and implementation of our monitoring activities, the conduct of risk assessments and the identification of mitigation strategies, the remediation of compliance deficiencies, the management of compliance systems, the preparation and delivery of compliance training and in cross-functional projects. The Specialist will also assist the Ethics & Compliance Officer in providing compliance guidance and direction to OCPI about relevant laws, Health Canada regulations, industry standards, such as Innovative Medicines Canada’s (IMC) Code of Ethical Practices, and Otsuka’s policies.

Responsibilities:

  • Assist or lead the development and update of OCPI’s compliance procedures, forms and templates and systems, and the related training materials, in collaboration with relevant business partners to ensure compliance to laws, regulations, industry standards and Otsuka policies, and efficacy and efficiency of business processes
  • Review routine field and Head Office projects involving services from or provision of value to Health Care Professionals (HCPs), Organizations (HCOs) or other healthcare stakeholders, and of third party funding requests
  • Manage or coordinate compliance audits and monitoring activities under the direction of the Ethics & Compliance Officer
  • Proactively inform the Ethics & Compliance Officer of potential non-compliance, and participate in organizational response, such as assessment of causes, development of corrective action and prevention strategies
  • Deliver live or web compliance training as required
  • Manage OCPI’s learning management system (Compliance Wire) and other compliance systems
  • Prepare compliance presentations and reports (for ex. training status, management action plan progress, compliance committee updates, etc.)
  • Facilitate submission of requests for interactions with foreign HCPs or of activities held outside of Canada with other Otsuka affiliate’s compliance function
  • Act as Compliance function representative in key company projects with compliance implications (for ex., CRM or Finance system changes)
  • Provide guidance and support on compliance issues related to OCPI activities
  • Reporting Safety Information, Product Quality Complaint and Customer Feedback as per training on current procedures

Qualifications and Key Competencies:

  • Excellent project management and organizational skills
  • Ability to multitask and prioritize based on importance and urgency of tasks
  • Excellent analytical and problem-solving skill; detail-oriented, yet able to synthesize
  • Great interpersonal relations, able to partner and work effectively in teams
  • Strong communication and drafting skills, good listener
  • Excellent Microsoft Excel skills, good Word and PowerPoint skills
  • Able to handle pressure and handle confidential information with discretion
  • Good judgement, able and willing to explain rationale behind recommendations
  • Proactive and fast learner, comfortable with new technology and systems
  • Open minded, able to work autonomously and navigate ambiguity
  • Bilingual (French & English)
  • Good knowledge of compliance and audit practices
  • 5 to 10 years or more relevant working experience in a compliance, legal, audit, marketing, sales, regulatory, medical, procurement or other related field in the Life Science, Pharma or other regulated industry preferred
  • Good knowledge of IMC Code of Ethical Practices and other applicable guidelines and regulations (Health Canada advertising guidance, Pharmaceutical Advertising Advisory Board (PAAB) Code) an asset
  • Compliance-related degree (Law, Finance) an asset, bachelor’s degree preferred

 

Supervision of Others:

None