Associate Director, Global Material Review Operations

Location: Barcelona Spain (On-site) / 3 days working from the office.

This is what you will do:

Join us in playing a pivotal role leading the charge to ensure operational excellence and seamless Global Material Review operations in GMIMR. As an Associate Director you will coordinate and assist with overseeing the meticulous execution of processes ensuring adherence to required timelines Standard Operating Procedures and the G-MLR Framework. In this role you will:

• Coordinate activities of the G-MLR support team including the execution and monitoring of the Day-to-Day Global Materials Review processes quality and compliance.
• Collaborate extensively with cross-functional teams including Medical Affairs Regulatory Legal Compliance and global stakeholders to ensure review approval and dissemination of strategically aligned materials delivering quality efficiency and compliance.
• Leading core projects focused on enhancing systems processes and quality as well as supporting AI and other Innovation efforts across GMIMR including governance and continuous improvement.
• Assist with development and management of applicable SOPs working practices/instructions training materials and implement comprehensive onboarding and training programs with guidance from Director Global Materials Review Operations.

The Associate Director will work under the direction of Director Strategic Operations and Excellence and collaboaratively with Director Global Material Review Operations to support both Global Materials Review processes and business operations excellence for GMIMR.

Bring your expertise and leadership to a role that is central to ensuring quality compliance and strategic alignment in medical communications.

You will be responsible for:

• Process Excecution: Provide coordination of for day-to-day operations of medical legal and regulatory review of nonpromotional materials in adherence to Standard Operating Procedures (SOPs). Provides SME guidance and ensures effective capacity management. Assists with budget planning and oversight.
• G-MLR Framework: Cultivate G-MLR process subject matter expertise. Asist with develops and management of departmental policies and SOPs Work Instructions including deviations with guidance from Director G-MLR. Manages G-MLR continuous improvement roadmap.
• Stakeholder Collaboration: Work with therapeutic area Medical Review Medical Affairs Regulatory Legal Compliance Medical Communications PRC MRC and other cross-functional partners to ensure quality and compliance with SOPs and process effectiveness. Proactively identifies issues and collaboratively participates in analysis facilitating resolution.
• Metrics and Reporting: Support the Director Global Materials Review in Monitoring and analyzing process performance and maintains reporting dashboards assisting with report preparation supporting the achievement of organizational objectives and G-MLR KPIs.
• Quality and Compliance: Support the Director Global Materials Review on inspections/audits of both internal and third-party vendors conducted by R&D Quality and/or regulatory health agencies; facilitates submission and resolution of deviations and CAPAs for the department.
• Documentation and Training: Responsible for organizing and maintaining process documentation and ensuring effective onboarding and training is delivered to team members and cross-functional stakeholders. Implements knowledge management best practices.
• Projects and Initiatives: Leads and supports Cross-Functional Projects and implementation of Continuous Improvement Quality and Innovation projects. Assists with executing tactical and ad-hoc deliverables as requested by leadership.
• Vendor Coordination: Monitors performance and coordinates activities with external agencies and vendors.
• GMIMR Systems: Coordinates system monitoring evaluation enhancement and issue resolution for G-MLR in partnership with IT Team.

You will need to have:

• Bachelors degree and 5 years experience in operational or project management within the pharmaceutical or biotech industry with 2 years experience in Materials Review Medical Information or other Medical Affairs Operations functions.
• Experience in global matrixed team collaboration.
• Understands drug development regulations adverse events and product complaint reporting audits and inspections.
• Demonstrated operational management skills to develop policies SOPs and training materials.
• Familiarity with development of effective work practice documents and effective training materials or equivalent knowledge materials.
• Proficient in problem-solving strategic thinking decision-making and detail orientation.
• Excellent cross-functional collaboration written and verbal communication skills.
• Demonstrated project management abilities and leadership in matrix environments.
• Self-driven with strong organizational and planning skills.
• Experienced with validated systems change control processes and high proficiency with Microsoft Office Suite.
• Role typically performed in an office setting requiring computer use communication skills problem-solving and collaboration during standard business hours.

We would prefer for you to have:

• 5 years of biotech/pharmaceutical/device industry experience
• Experience with Veeva Vault (Veeva MedComms / Veeva Promomats) digital asset management system
• Experience configuring/managing a database and working and partnering with IT colleagues to implement solutions
• Certification in Project Management and Continuous Improvement methodologies a plus (e.g. Lean Six Sigma PMP etc.)
• Experience working in Medical Review Committee Operations
• Experience developing Policies Standard Operating Procedures (SOPs) Work Practice Documents etc.
• Experience leading upgrade implementation or migration of new system/software

Experience managing vendor teams

Date Posted

Closing Date

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 lackthereof sex sexualorientation age ancestry national origin ethnicity citizenship status marital statuspregnancy (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 aninteractive dialogue with Alexion regarding an accommodation please contact . Alexion participates in E-Verify.