Biogen

Risk

• Partner with cross functional teams to identify critical data and processes (CDPs) and associated study risks
• Support the development and maintenance of the study-specific Risk Assessment Categorization Tool (RACT) or equivalent
• Prioritize risks and signals based on patient safety impact, data integrity, severity, likelihood, and detectability
• Conduct proactive, ongoing data reviews using RBQM dashboards and analytics tools
• Ensure timely escalation and follow up on any signals or anomalies
• Triaging: prioritize, escalate, and track signals
• Review and validate data across EDC, safety, and other clinical systems to ensure consistency and quality
• Oversee data cleaning timelines and ensure adherence to risk mitigation plans
• Partner with study teams to ensure data flow mapping supports early risk detection
• Document and communicate findings clearly and effectively to study teams
• Trigger or support Corrective and Preventive Actions (CAPA)
• Participate in root cause analyses for major deviations or quality concerns
• Ensure alignment with ICH-GCP, FDA/EMA regulations, and internal SOPs.
• Support audit and inspection readiness related to RBQM and centralized monitoring
• Contribute to process enhancements, technology upgrades, and RBQM best practices
• Partner with platform/analytics teams to enhance dashboards and detection logic; perform UAT and help shape product roadmaps
• Provide training, guidance, and mentorship on RBQM concepts to study teams.

Principal Risk-Based Quality Management Data Monitor

Manager

• Provide field coaching and support, ensuring effective use of tools, tactics, messages, and trainings provided by the business.
• Participate in the development & support of marketing strategies, tactics, and messages by surveying/coaching the execution efforts in the field on a consistent basis.
• Assist in the development and execution of all on-boarding training of new hires.
• Indirectly lead the Field Force Trainers for new hire and on-going training execution.
• Partner with field leadership to determine skill gaps, training needs and coaching opportunities through field observation.
• Partner with Sr. Leadership on execution of field coaching and coaching reports
• Provide feedback and leadership to home office from regular field observation, in preparation for regional/national meetings and to highlight best practices.
• Play a pivotal role in the creation and execution of development workshops at regional & national meetings to support the objectives of marketing & leadership.
• Build a network of internal and external rare disease resources to support field development through advocacy, rare disease events and national conferences.
• Partner with leadership and home office to utilize the family access critical skills/key experience and performance models for use in conjunction with the hiring process, professional evaluation, and development at the field level, & across internal stakeholders to spread awareness/understanding of the family access role.
• Help identify, coach, and develop transferrable skills specific to the family access team to prepare for Biogen roles/contributions beyond family access.
• Work collaboratively with Biogen counterparts across the organization to determine best practices and leverage an enterprise ONEBIOGEN approach to training, development, and field execution.
• Uphold the cultural values and family access interpretation to assist leadership with examples of those values in action.
• Identify and determine on-going development needs with patient engagement, motivational interviewing, and national skill-based programs.
• Design & execute additional national trainings.
• Lead the partnership with external vendors to meet any training needs.
• Support the evolution and execution of a sustainable patient support model for engagement with patients in the maintenance phase of the patient journey.
• Provide individual coaching, assess metrics in partnership with patient services & leadership, and work closely with marketing to support execution of key strategic initiatives.
• Maintain up to date knowledge on all Biogen, disease, patient engagement, and product related resources/models to support current and future patient care needs.
• Participate in key cross-functional task forces with business partners such as marketing insights, competitive intelligence, patient services, and marketing.

Senior Manager, Rare Disease Family Access Field Excellence

Operations

• Monitor operational performance and generate predictive insights across portfolio and program levels.
• Lead Planisware systems integration and enablement support in partnership with IT and vendors.
• Build and maintain resource management and forecasting algorithms to enhance forecast consistency and transparency.
• Develop and guide operational analytics products and data visualizations for effective reporting.
• Assess and streamline the current analytics landscape to ensure alignment with decision-making needs.
• Drive continuous improvement in analytics processes and ensure effective knowledge transfer.
• Collaborate cross-functionally to support systems integration efforts and ensure technology and analytics alignment.

Senior Operations Analyst

Director

• Design and execute primary market research such as segmentation, message testing, and patient/HCP studies
• Analyze and synthesize secondary data, including claims and market data, to track performance and surface opportunities
• Serve as the go-to insights partner for the asset, aligning work to brand priorities and decision points
• Own the integrated insights narrative across research and secondary analytics; translate findings into clear recommendations
• Frame ambiguous problems, propose the right research/analytics approach, and manage vendor scope, timelines, and deliverables end-to-end
• Develop executive-ready materials tailored to senior stakeholders and present them with clarity and confidence
• Partner cross-functionally with teams like Marketing and Market Access to translate insights into action
• Contribute to Integrated Customer Planning (ICP) and budget planning by providing customer/market inputs
• Support KPI and dashboard requirements by defining questions, metrics, and implications with analytics partners

Principal Risk-Based Quality Management Data Monitor

Senior Manager, Rare Disease Family Access Field Excellence

Senior Operations Analyst

Associate Director, Integrated Insights, Analytics and Market Research