Director, Global Materials Review Operations at AstraZeneca

Mississauga, Ontario, Canada -

Full Time

Start Date

Immediate

Expiry Date

06 Mar, 26

Salary

0.0

Posted On

06 Dec, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Medical Materials Review, Promotional Materials Review, Regulatory Compliance, Project Management, Stakeholder Management, Process Improvement, Vendor Management, Data Analysis, Training Development, Digital Transformation, Change Management, Collaboration, Communication, Problem Solving, Leadership, Strategic Planning

Industry

Pharmaceutical Manufacturing

Description

This is what you will do: The Director of Global Materials Review Operations is a key leader within the Global Medical Review team, responsible for ensuring operational excellence across the Global Materials Review process. This includes oversight of medical, legal, and regulatory review for promotional and non-promotional “Above-Market” materials. The role drives strategic alignment, governance, and compliance across global and local markets while leading cross-functional collaboration and innovation initiatives to enhance review processes. The Director serves as a subject matter expert, closely partnering with Reviewers, Project Owners and senior stakeholders, supporting business-critical objectives, reporting, data and insight driven decision-making and continuous process improvement. This position requires extensive expertise in Medical and/or Promotional Materials Review and related systems, as well as a strong understanding of upstream and downstream processes. The Director must demonstrate the ability to influence consensus independently, solve complex problems collaboratively, and align diverse stakeholders, including senior leadership. In addition, the Director oversees vendor teams and supports the development of local team members ensuring proactive management, operational excellence and business continuity. The Director will also be responsible for developing and maintaining SOPs, work instructions, and training materials, and ensuring that all MR team members are appropriately trained. You will be responsible for: Oversee the end-to-end Medical Materials Review (MR) process, ensuring compliance with SOPs, governance frameworks, and audit readiness. Drive strategic operations governance, process maturity, innovation, and digital transformation initiatives. Lead and support strategic projects across GMIMR and broader Medical Affairs, aligned with organizational goals. Champion launch planning excellence and readiness across therapeutic areas. Collaborate with TA MR, IT, and GRC Leads to ensure alignment, achieve objectives, and resolve issues effectively. Provide oversight of cross-functional engagement, escalation pathways, and issue resolution. Manage stakeholder relationships across global, local, and expansion markets to ensure alignment and engagement. Govern processes including SOP/WI development, business continuity planning, and compliance leadership. Drive capacity planning, forecasting, and resource optimization aligned with strategic priorities. Analyze and deliver quarterly metrics and KPIs to enable data-driven decisions and performance tracking. Support budget planning, contract management, accruals, and performance management for MR operations. Lead G-MLR Leadership Team meetings, set agendas, and oversee delivery of action items. Execute continuous improvement initiatives and roadmap delivery. Advance digital operations and innovation in partnership with IT and business stakeholders. Develop local team capabilities aligned with global strategy and foster a high-performing culture. Manage third-party vendors, ensuring quality and alignment with operational and performance goals. Position MR Operations as a leader in compliance and audit excellence. You will need to have: Advanced degree in a related SME field or BA in a related SME field with required minimum of 5-7 years of medical or commercial materials review experience in the pharmaceutical / biotech industry SME Experience Demonstrated experience with the Medical and Promotional Materials Review Process and operations management as well as Legal and Regulatory Requirements. Understands drug development process, US (FDA) and global (e.g. EMEA) regulations and reporting requirements for reporting adverse events and product complaints, experience in associated audits and inspections. Demonstrated experience collaboratively leading the development of work practice documents, SOPs, and effective training materials. Hands-on experience in-depth expertise with Veeva Vault Veeva Vault (Veeva MedComms / Veeva Promomats) (or equivalent materials review systems) and related systems change leadership in a global environment. General Experience: People management experience in a global organization. Demonstrated ability to develop staff Excellent verbal and written communication skills as well as strong interpersonal and tactful negotiation skills Project management skills with proven ability to prioritize, conduct, and meet project deadlines. Demonstrated ability to Lead projects of strategic importance, including managing multiple projects simultaneously Proven ability to exercise problem solving and strategic thinking skills; and has foresight and judgment in making complex decisions Flexibility, the ability to adapt to change in rapidly evolving environment Vendor management experience Self-motivated to drive for results, with strong organizational and planning skills Highly proficient with Microsoft Office Suite Ability to travel to meetings / conferences (domestic and international) approximately 5-10% of the time We would prefer for you to have: Experience in product launch planning and execution in the pharmaceutical or related industry. Experience working with validated systems and the change control process. Knowledge and exposure to the breadth of activities undertaken within a Global Medical Affairs organization. Experience working in Medical Review Committee Operations Exposure to various systems such as SharePoint, Box, Smartsheet, SumTotal, Trackwise, RightFind, Argus, Veeva Vault, MedComms, FirstDoc; Adobe Captivate; Brainshark; and data analytics software Training or past experience in Alexion-associated therapeutic area(s) or rare-disease Experience partnering with IT organization as business SME for systems related implementations, migration and enhancement Certification in Change Management, Continuous Improvement, Project Management and/or Lean Six Sigma/Agile Methodologies is highly desirable. Great People want to Work with us! Find out why: GTAA Top Employer Award for 11 years Top 100 Employers Award Canada’s Most Admired Corporate Culture Learn more about working with us in Canada View our YouTube channel Are you interested in working at AZ, apply today! AstraZeneca is an equal opportunity employer that is committed to diversity and inclusion and providing a workplace that is free from discrimination. AstraZeneca is committed to accommodating persons with disabilities. Such accommodation is available on request in respect of all aspects of the recruitment, assessment and selection process and may be requested by emailing AZCHumanResources@astrazeneca.com. #LI-hybrid Date Posted 05-Dec-2025 Closing Date 18-Dec-2025 Alexion is proud to be an Equal Employment Opportunity and Affirmative Action employer. We are committed to fostering a culture of belonging where every single person can belong because of their uniqueness. The Company will not make decisions about employment, training, compensation, promotion, and other terms and conditions of employment based on race, color, religion, creed or lack thereof, sex, sexual orientation, age, ancestry, national origin, ethnicity, citizenship status, marital status, pregnancy, (including childbirth, breastfeeding, or related medical conditions), parental status (including adoption or surrogacy), military status, protected veteran status, disability, medical condition, gender identity or expression, genetic information, mental illness or other characteristics protected by law. Alexion provides reasonable accommodations to meet the needs of candidates and employees. To begin an interactive dialogue with Alexion regarding an accommodation, please contact accommodations@Alexion.com. Alexion participates in E-Verify.

Responsibilities

The Director oversees the end-to-end Medical Materials Review process, ensuring compliance and operational excellence. They drive strategic operations governance and lead cross-functional collaboration to enhance review processes.