Coordinator, Legal Affairs & Compliance

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

Reporting to the Director, Legal Affairs & Compliance, this position is instrumental in ensuring the performance and success of the day to day operations and processes for this department through organizational and technology skills.  Located at the Canadian head office, this position will be called upon to work with all departments, and business partners, including the Leadership Team, senior management, field sales, medical & regulatory, vendors, Health Care Professionals (HCPs), US and Global Otsuka colleagues and alliance partners.

Responsibilities:

Contracting and document preparation

  • Prepare, coordinate and oversee the development, update and translation of contractual documentation (including but not limited to Confidentiality Agreements, Master Services Agreements, Task Orders, Consulting Agreements, Sponsorship Agreements, Co-Promotion Agreements, Quality Agreements, Pharmacovigilance Agreements, wholesale, distribution and buying group agreements, etc.)
  • Coordinate contract execution, as required
  • Coordinate with Finance to resolve monetary/payment issues raising contractual questions
  • Manage contract database and systems and related processes
  • Maintain a directory of all contracts that contain pharmacovigilance/safety reporting obligations and reporting new agreements executed on a monthly basis
  • Prepare and support Legal Affairs and Compliance training programs and presentations
  • Act as Legal Designee in the promotional review committee, review all materials for correct trademarks and copyrights
  • Coordinate the Board of Directors meetings and prepare agendas, resolutions, minutes and presentations
  • Coordinate and support special projects (ex: Office Québécois de la langue française requirements)

Intellectual Property

  • Support the development and update of Brand Books (proper usage of intellectual property) for each of the Canadian products and use of Corporate Branding
  • Support global alignment on intellectual property protection for our patents, trademarks and copyrights, etc., including administrative support for legal review of product labels

Compliance Policies & Procedures

  • Participate in development and update of internal standards (policies, procedures and templates)
  • Develop and maintain systems, forms, templates and other tools supporting compliance to internal standards, including system for collection, review and retention of required documentation and review of interactions resulting in provision of value with Health Care Professionals (HCPs) and Institutions (HCIs)
  • Support for the development and implementation of the Company’s Document Retention Policy
  • Preliminary screening of briefing forms

Cross-Border Interactions with HCP & Stakeholders

  • Coordinate requests for interactions with foreign HCPs or outside of Canada (including through the US Healthcare Interaction Portal), to ensure completion of appropriate documentation and receipt of required approvals

Compliance Program Monitoring, Enforcement, Response and Reporting

  • Compliance Committee support (scheduling, agenda, content drafting and minutes)
  • Assist in the implementation of compliance auditing and monitoring plan
  • Assist Ethics & Compliance Officer in conduct of investigations and implementation of Corrective Action Plans (CAPA)

Compliance Training

  • Manage the Learning Management System (LMS), maintain user groups and training curricula (including those for vendors), track completion of training and perform follow-ups and reporting for GxP & Compliance Control Documents as well as all other related training documents
  • Obtain from each Functional Area Representative the training assignments for each curriculum
  • Ensure review of Global Procedural Documents and maintain a Global GxP SOP review tracking sheet as per CAPA
  • Liaise with G-SOP Office, OAPI EQC Document Control and Global PV Training functions

Grants and Donations

  • Manage Grant Review Committees and coordinate meetings and agendas
  • Track all grant and donation requests. Provide prompt follow-ups and responses to requestors
  • Generate all relevant contracts, e.g. educational grants, corporate sponsorships, or international conference attendee sponsorships
  • Ensure accurate budgeting and issue reports in a timely fashion

Other tasks

  • Develop and maintain Compliance and Legal departments’ intranet/SharePoint sites
  • Oversee translation of departments’ documents and perform translation as required
  • Provide general administrative support to the Director and team, including meeting and travel arrangements
  • Track the legal budget and coordinate payments with the external counsel legal firms
  • Provide live training as required
  • Reporting Safety Information, Product Quality Complaint and Customer Feedback as per training on current procedures
  • Responsible for Legal & Compliance document repository and related system.

Qualifications and Key Competencies:

  • Excellent project management and organizational skills
  • Demonstrated ability to multitask and prioritize based on importance and urgency of tasks
  • Minimum 5-10 years of experience working as a coordinator/administrative assistant, ideally in a pharmaceutical or healthcare environment, based in a Compliance and/or Legal department
  • Very detail-oriented, yet able to synthesize
  • Self-starter, responsible, and keeps things moving and on time
  • Experience working with senior professionals in a fast-paced environment, maintains composure
  • Handles confidential information with discretion
  • Good decision-making skills
  • Great interpersonal relations and demonstrated ability to work effectively in teams
  • Comfortable at managing, using and implementing new technologies, systems and platforms
  • Experience managing contracts and web-based systems, including database management
  • Proactive and fast learner
  • Strong verbal and written communication skills
  • Open minded, able to work autonomously and manage ambiguity
  • Exceptional MS Office skills
  • Bilingual (French and English), written and spoken

Supervision of Others:

None