Medical Governance Manager

This is a role within the Medical Division, reporting into the Medical Governance Lead. The mandate of the Medical Governance Manager (MGM) is to provide medical governance support for the entire Medical Division in Canada. The role will manage the systems and processes to support medical governance in addition to risk management and management monitoring. The role will ensure that high risk areas are being identified and mitigated in the following key areas: Human Subject Research, Human Safety Information and Scientific Engagement.

This role will require you to contribute to audit, inspection readiness and operational excellence activities. The MGM role has one direct report, Medical Governance Associate (MGA), who is responsible for the administrative support within medical governance, maintaining the myLearning database and facilitating the management monitoring for the Medical Division.

Key Responsibilities:

• Lead and coordinate risk management and management monitoring in the Medical Division.
• Advise the Medical Division and business on medical governance issues to reduce risk and ensure compliance with Canadian policies, procedures, and external regulations for new initiatives.
• Partner with other Medical functions and cross-functional teams to ensure medical governance while engaging with external experts using a cumulative risk-based approach.
• Support local and global initiative rollouts as it relates to medical governance (ex., MSL ways of working, implementation of non-promo activities).
• Escalate & collaborate cross-functionally as it relates to medical governance and be a member of above country networks (ex. GCI Medical Risk Management and Management Monitoring [RM&MM]).
• Build & sustain strong working relationships with Global GCI RM&MM and cross-functional teams to ensure the Canadian medical voice is heard.
• Lead the design of the training strategies and lifecycle management of written standards & controls for the Medical Division.
• Oversee the evaluation, strategic planning, and execution of medical capability and competency training concerning medical governance.
• Support audit and inspection readiness activities including compliance monitoring.
• Support Grants & Donations Chair and Committee.
• Act as point of contact for medical compliance review.

Lead the execution of Canada’s voluntary disclosure of payments to Health Care Professionals (HCPs) and Health Care Organizations (HCOs).

Education

• Minimum Bachelor’s Degree in science (BSc or MSc), business management (MMI or MBiotech), and/or relevant field, advanced degree preferred.

Experience and Skills

• Previous experience managing and developing direct reports is desirable with 3+ years of experience in the pharma industry.
• Experience in the pharmaceutical industry with expertise in Medical Affairs, preferably in Medical Governance, Compliance, risk management, or a related field. Experience in more than one of these areas is desirable.
• Proven track record of collaborating with commercial and medical colleagues, as appropriate.
• Knowledge of platforms and systems used within the pharmaceutical industry.
• Experience in a highly regulated environment with thorough knowledge of Canadian policies and regulatory requirements.
• Must possess a good understanding of the Canadian healthcare environment, GxP processes, and medical guidelines.
• Experience in risk assessments, audits, and managing CAPAs.
• Enterprise mindset and strategic thinker with the ability to successfully engage multiple stakeholders.
• Ability to lead with influence and impact as an individual contributor.
• Proactive, self-motivated, accountable and flexible with the ability to work independently and in team settings.
• Experience in managing complex projects and implementing processes, with skills in problem-solving and effective prioritization.
• Proven communication skills using various mediums, as well as strength in negotiation and influencing skills.
• Adaptable and open to change with a willingness to continuously learn and improve.
• Strong ethical standards.

High attention to detail and strong organizational skills.