Directeur(trice) associé(e), Affaires médicales /Associate Director, Medical Affairs

Merck•Kirkland, QC

1d•Hybrid

About The Position

The Associate Director, Medical Services, is a key leadership role within Medical Affairs, responsible for the strategic and operational oversight of Medical Services, including Designated Points of Contact (DPOC), medical review, related governance activities to drive the successful achievement of the department’s vision, mission, and objectives. This role is accountable for the delivery of high-quality, compliant, and patient-centric medical processes while driving operational excellence and continuous improvement. The incumbent plays a critical role in shaping Medical Affairs strategy through coaching, active participation in the Medical & Scientific Affairs Leadership Team (MALT), cross-regional leadership forums and collaboration with Global Medical Operations. The Associate Director will lead a high-performing team, foster cross-functional alignment, and ensure readiness in a complex and evolving regulatory environment. The role oversees a team of four (4) and manages key external vendors supporting DPOC operations.

Requirements

University degree in Pharmacy with a valid license to practice pharmacy in Quebec.
Minimum 5 years of experience in the pharmaceutical industry within medical affairs, medical information or related functions required and ideally a minimum of 2 years of people management experience.
Practical knowledge in a clinical setting, i.e., working in pharmacies, hospitals, nursing homes, in close contact with patients and/or healthcare professionals.
Excellent knowledge or PAAB Code of Advertising Acceptance, Innovative Medicines Canada Code of Ethical Practices, Health Canada Requirements, Corporate requirements (including those related to Pharmacovigilance, Quality Operations, Global Medical Scientific Affairs, etc.)
Experience in vendor management, audit readiness, and cross-functional collaboration.
Excellent written / oral communication skills in both French and English.
Strong personal integrity and high ethical standards.
Ability to organize, prioritize, and work effectively in a constantly changing environment
Strong decision-making, problem-solving and analytical skills, with ability to innovate with practical solutions for complex issues
Demonstrated skills in leadership, strategic thinking, people development, analysis, continuous improvement and innovative mindset.
Ability to work independently while escalating risks and issues as appropriate.

Responsibilities

Lead, coach, and develop a high-performing Medical Services team of four team members, fostering engagement, accountability, and continuous development and growth (i.e., mid- and year-end reviews, ongoing feedback, talent management, succession planning, recruitment and retention)
Drive strategic alignment with local and Global Medical Affairs priorities, vision and mission as a science-driven and patient-committed organization
Stays current with key initiatives across Commercial and Global Medical Operations, and supports leadership colleagues in delivering against organizational priorities while driving efficient and compliant execution of Medical Services activities
Exhibits executive presence, deep subject matter expertise and strong business acumen
Champion a culture of compliance, innovation, agility, transformation and patient-centricity
Use data and insights to guide decisions and improve operational performance
Provide end-to-end oversight and accountability for DPOC operations, including vendor management to deliver accurate intake, triage, documentation, and routing of medical inquiries as per standards and compliance
Define and oversee governance frameworks (SOPs, work instructions, Quality Assurance processes).
Lead process assurance and continuous improvement initiatives, including periodic reviews to sustain effectiveness and compliance with internal policies and regulatory standards.
Manage Corrective Actions Preventive Actions and ensure compliance with regulatory and internal requirements; Report to the Medical council as required
Partner with Pharmacovigilance, Quality, Compliance, Legal, and Information Technology teams to enable seamless operations.
Define and implement DPOC ways of working for business alliances and partnerships.
Collaborate with cross-functional teams to drive audit and inspection readiness (including Health Canada) and participate in compliance audits and inspections as required.
Ensure medical review of promotional and non-promotional materials is scientifically rigorous, balanced and align with business strategy.
Maintain full compliance with applicable laws, regulations, industry codes and company policies.
Optimize resource allocation and workload management across reviewers.
Be responsible for appropriate training and certification (e.g., PAAB).
Collaborate with Legal and Commercial teams to establish efficient and consistent review processes; Drive alignment with business strategy and regulatory requirements.
Establish common ways of working (Standard Operating Procedures, Work Instructions, Templates, Onboarding) with cross-functional stakeholders to ensure that all materials are aligned with applicable company policies and procedures and meet the Canadian regulations and industry code.
Support resolution of product-related issues in the marketplace, and collaborate to establish ways of working for the medical review requirements in Business Alliance agreements.
Establish and monitor Key Performance Indicators and performance metrics to drive continuous improvement
Explore opportunities to enhance Medical Services through digital tools and process innovation
Maintain compliance with Health Canada regulations, PAAB Code of Advertising Acceptance, Innovative Medicines Canada (IMC) Code and Corporate policies (Pharmacovigilance, Quality, Data Privacy)
Drive timely reporting of Adverse Events (AEs) and Product Quality Complaints (PQCs) in alignment with our Company’s commitment to its Code of Conduct, Our Values and Standards, policies, procedures, industry standards and all laws and regulations
Ensure that any confidential information or personal data related to the customers is managed in accordance with Data Privacy regulations as per our Company's standards
Maintain a strong audit and inspection readiness posture
Act as a trusted strategic partner to internal stakeholders, ensuring alignment and effective decision-making
Provide medical oversight and expertise in key governance forums, including Sponsorship Review Committee, Patient Support Program (PSP) Review Board and Health Canada Special Access Program (SAP) criteria definition
Maintain Medical Significance Lists and support product lifecycle decisions
Collaborate on supply-related decisions (allocation, backorders, recalls)