Position Summary
Join us in playing a pivotal role within GMIMRCC Operations as part of the GMR Operations Center of Excellence (CoE), enabling the compliant, efficient and scalable execution of the Global Materials Review (GMR) Framework, including medical, legal and regulatory review of promotional and non-promotional above-market global materials.
As Senior Manager, GMR Operations CoE, you will provide operational leadership and hands-on execution across end-to-end Global Materials Review activities, partnering with Project Owners, Reviewers and cross-functional stakeholders across Medical, Regulatory, Legal, Compliance, Technology and Operations. You will also partner closely with other CoE team members to enable consistent execution, shared ways of working and effective management of priorities across GMR operations. The role is accountable for workflow performance, submission readiness and quality, issue and risk management, prioritization and delivery of business priorities through standardized and compliant review processes.
As a subject matter expert in GMR operations, workflow governance and enabling technologies, you will drive operational excellence, standardization and continuous improvement; monitor performance and provide data-driven recommendations; and support the implementation, adoption and optimization of approved digital and AI-enabled capabilities. The role exercises independent operational judgment and provides appropriate human oversight of AI-enabled outputs to ensure quality, compliance, accuracy and effective application within operational workflows.
You will be responsible for:
Materials Review Operations Execution & Compliance
- Planning, Prioritization & Capacity Management: Lead materials review planning and prioritization across GMR workflows, balancing surge demand and business-as-usual activities (e.g., launches, congresses, centralized content). Partner with Project Owners and Reviewers to triage intake, assess submission readiness, sequence work, align review pathways and timelines, and identify capacity or resource constraints.
- Stakeholder Alignment & Decision Facilitation: Lead concept reviews, planning discussions and review forums to drive alignment, timely decision-making and resolution of operational challenges, including appropriate escalation. Establish clear ownership, accountability and follow-through, and champion effective meeting practices.
- Workflow Performance Management: Maintain visibility of work in progress and operational performance measures, identifying trends, risks, dependencies, bottlenecks and capacity constraints. Use operational data to recommend and drive actions that improve review quality, predictability, cycle times, efficiency and stakeholder experience.
- Operational Decision-Making: Exercise independent judgment in assessing submission readiness, determining appropriate operational guidance, prioritizing work, and identifying workflow routing and escalation requirements to support compliant and timely execution.
- Issue, Risk & Escalation Management: Identify and assess operational risks, lead resolution of issues within scope, and escalate matters requiring cross-functional alignment, governance review or strategic decision-making, providing analysis and recommendations to support timely resolution.
Veeva Workflow Management & Quality Oversight
- End-to-End Workflow Management & Oversight: Serve as the operational SME for Veeva-enabled GMR workflows for all stakeholders, ensuring consistent application of SOPs, guidance and approved ways of working across brands and markets. Oversee workflow integrity, routing and compliant execution, including engagement of Global Nominated Signatories and Local Market Reviewers.
- Submission Readiness, Quality & Lifecycle Management: Independently assess submission readiness, metadata accuracy, documentation completeness and workflow compliance. Drive materials through quality checks, review, approval and finalization, resolving operational issues and minimizing avoidable rework throughout the review lifecycle.
- System Expertise, User Enablement & Optimization: Provide SME guidance for Veeva PromoMats, troubleshoot workflow and system issues, promote best practices, and support onboarding, access management and effective use of approved capabilities. Identify and recommend process, technology and digital/AI-enabled improvements that drive adoption of features and tools that enhance submission quality, workflow effectiveness, system utilization and stakeholder experience.
Stakeholder Management and Enablement
- Stakeholder Engagement & Alignment: Build effective partnerships with Project Owners, Reviewers, agency partners and cross-functional stakeholders to align priorities, communicate decisions and timelines, and resolve operational challenges throughout the review lifecycle.
- AI-Enabled Operations & Continuous Improvement: Lead implementation, adoption and optimization of approved AI-enabled and digital enhancements to improve operational efficiency, quality and stakeholder experience, providing human oversight to ensure appropriate and compliant use.
- Stakeholder Onboarding & Training: Lead onboarding and stakeholder enablement through training, coaching, office hours and targeted guidance to improve quality, compliance, consistency and adoption of approved processes and technologies.
- Cross-Brand & Market Alignment: Promote consistent ways of working across therapeutic areas, brands and markets by sharing best practices, supporting content reuse and identifying opportunities for greater operational effectiveness.
- Operational Reporting & Workflow Visibility: Generate and maintain Veeva PromoMats reports and dashboards covering review volumes, cycle times, workflow status, capacity and performance. Use reporting to identify bottlenecks, risks and emerging issues and support day-to-day operational decision-making.
Knowledge, Documentation & Inquiry Management
- Process Documentation & Knowledge Management: Maintain accurate and current work instructions, templates, trackers, playbooks and reference materials, incorporating operational learnings and applying best practices to support compliance, consistent execution, onboarding, business continuity and knowledge sharing.
- Operational Inquiry & Service Management: Manage the Operations inquiry and intake process, triaging and resolving operational questions and support requests, coordinating responses across stakeholders, and identifying recurring issues or knowledge gaps requiring process clarification, documentation updates or stakeholder enablement.
Essential Qualifications
- Bachelor's degree in Life Sciences, Business, Operations, Healthcare or related discipline.
- 3–5 years of relevant experience in pharmaceutical, biotechnology, Medical Affairs, Medical Information, promotional review, regulatory operations, content management or another regulated environment.
- Minimum 2 years of project management, project coordination, program support or operational workstream leadership experience, including management of cross-functional stakeholders, competing priorities and complex workflows.
- Experience in Medical Affairs, GMR/MLR, or a closely related medical, regulatory or scientific communications environment.
- Demonstrated understanding of medical and promotional materials review processes, including applicable Legal and Regulatory requirements.
- Hands-on experience with Veeva Vault, including PromoMats/MedComms, or comparable regulated workflow/content-management systems.
- Demonstrated ability to exercise independent judgment in assessing operational readiness, prioritizing work, identifying risk and driving issue resolution.
- Experience using operational reporting, workflow metrics and performance data to identify bottlenecks and support operational decision-making.
- Experience supporting stakeholder engagement, training, process adoption and operational enablement.
- Demonstrated proficiency with digital and AI-enabled tools for analysis, summarization, workflow support and operational efficiency.
- Strong communication, facilitation, planning and problem-solving skills, with the ability to influence outcomes in a global, matrixed and SOP-driven environment.
Preferred Qualifications
- Experience working with validated systems, change-control processes and governed review, approval, workflow or content-management platforms.
- Experience with project management and continuous improvement methodologies.
- Experience in clinical operations, CRA, CTM or related domains.
- Experience developing SOPs, work instructions, policies or operational guidance.
- Experience supporting product launches or congress activities within pharmaceutical/biotechnology environments.
- Experience contributing to process improvement, workflow optimization, digital transformation or AI-enabled operational initiatives.
Date Posted
26-Oct-2026
Closing Date
08-Nov-2026
Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.
