Director, Commercial REMS Operations

Alexion • Boston, MA

1d • Hybrid

About The Position

This is what you will do: The Director, Commercial REMS Operations will own key strategies and tactics to support US Commercial activities related to Risk Evaluation and Mitigation Strategies (“REMS”) programs. This includes supporting the development, implementation, and ongoing management of REMS initiatives across US Commercial. The primary purpose will be to support US Commercial REMS Operations strategy and tactics. This will include supporting Field Sales Teams, Strategic Accounts, Patient Engagement Managers, OneSource Support Specialists, and all other external facing teams in their understanding of the REMS. This role will collaborate with personnel across Alexion and AstraZeneca to understand REMS needs, develop appropriate strategies, and manage the tactics that come from these strategies. This role will be critical to the development, implementation, and management of strategic initiatives that support a successful, compliant and efficient REMS and ongoing patient safety. You will be responsible for: Collaboration and Leadership: Collaborate with cross-functional teams, including US Commercial, Safety, Regulatory, Ethics & Compliance, and IT, to integrate REMS operational strategies across the organization. Partner with Commercial colleagues to ensure REMS strategy is pulled through successfully via aligned tactics. Support the update and alignment of internal processes and systems, as needed to support REMS activities. Project Management: Establish and follow project management guidelines that are scalable and can be leveraged across all REMS related projects. Consistently track against all actions/deliverables to ensure projects stay on track and on time. Support engagement with and overall strategy of external Commercial vendors enabling commercial REMS operations REMS Operational Support: Lead cross functional teams to design and implement initiatives that will positively impact and drive successful REMS enhancements. Partner with brand and training teams on supplemental material development and approval, training plan, and communication strategy. Support the Senior Director with maintaining internal communication between Commercial teams and any external partners on REMS topics. Support ongoing compliance and internal activities related to all active REMS. Coordinate REMS logistical activities across US Commercial Teams Support REMS audit activities, as needed. Support Alexion Field team queries, as needed. REMS Insights and Reporting: Develop and deliver REMS program operational insights and reports to business stakeholders, guiding strategic decisions. Drive insights on non-FDA REMS reports such as stakeholder engagement and REMS certifications. REMS Data Analysis, Quality, And Integrity: Act as the Commercial lead and support ongoing internal data and insight activities for all products and indications under the REMS. Ensure the accuracy, quality, and integrity of Commercial REMS data used for analysis and reporting. Develop, implement, and document processes to maintain high data quality standards. Utilize data sources to analyze and update operational strategies. Be responsible for the design and presentation of critical metrics to leadership. Product Launch Support: Support REMS operational activities and projects for new product launches and development of new REMS programs. Identify opportunities for leveraging REMS materials, processes and repositories to drive alignment, consistency and operational efficiency across products, indications, and the Commercial team. You will need to have: Education: Master’s or bachelor’s degree in relevant field (Business, Computer or Information/Data Sciences, Technology, Engineering, Mathematics) required. Advanced degree preferred. Skills/Experience: REMS Expertise: 5+ years in REMS operations, data, strategy, and tactical implementation. Deep knowledge of REMS compliance. Industry Background: Pharma/biotech experience, preferably within or partnering with Commercial teams. Commercial Breadth: Experience collaborating across sales, operations, patient services, analytics, vendor management, marketing, sales, market research, and/or medical affairs. Experience with new product launches and/or high-growth exposure. Leadership : Proven people and project management skills. Strong cross-functional collaboration skills within commercial settings. Data Skills: Strong analytics skills with ability to derive insights from complex datasets and manage multiple requests. Data Governance & Process: Familiar with data governance processes. Process-oriented mindset with strong problem-solving and workflow understanding to ensure data quality.

Requirements

• Master’s or bachelor’s degree in relevant field (Business, Computer or Information/Data Sciences, Technology, Engineering, Mathematics) required.
• 5+ years in REMS operations, data, strategy, and tactical implementation. Deep knowledge of REMS compliance.
• Pharma/biotech experience, preferably within or partnering with Commercial teams.
• Experience collaborating across sales, operations, patient services, analytics, vendor management, marketing, sales, market research, and/or medical affairs.
• Experience with new product launches and/or high-growth exposure.
• Proven people and project management skills. Strong cross-functional collaboration skills within commercial settings.
• Strong analytics skills with ability to derive insights from complex datasets and manage multiple requests.
• Familiar with data governance processes.
• Process-oriented mindset with strong problem-solving and workflow understanding to ensure data quality.

Nice To Haves

• Advanced degree preferred.

Responsibilities

• Collaborate with cross-functional teams, including US Commercial, Safety, Regulatory, Ethics & Compliance, and IT, to integrate REMS operational strategies across the organization.
• Partner with Commercial colleagues to ensure REMS strategy is pulled through successfully via aligned tactics.
• Support the update and alignment of internal processes and systems, as needed to support REMS activities.
• Establish and follow project management guidelines that are scalable and can be leveraged across all REMS related projects.
• Consistently track against all actions/deliverables to ensure projects stay on track and on time.
• Support engagement with and overall strategy of external Commercial vendors enabling commercial REMS operations
• Lead cross functional teams to design and implement initiatives that will positively impact and drive successful REMS enhancements.
• Partner with brand and training teams on supplemental material development and approval, training plan, and communication strategy.
• Support the Senior Director with maintaining internal communication between Commercial teams and any external partners on REMS topics.
• Support ongoing compliance and internal activities related to all active REMS.
• Coordinate REMS logistical activities across US Commercial Teams
• Support REMS audit activities, as needed.
• Support Alexion Field team queries, as needed.
• Develop and deliver REMS program operational insights and reports to business stakeholders, guiding strategic decisions.
• Drive insights on non-FDA REMS reports such as stakeholder engagement and REMS certifications.
• Act as the Commercial lead and support ongoing internal data and insight activities for all products and indications under the REMS.
• Ensure the accuracy, quality, and integrity of Commercial REMS data used for analysis and reporting.
• Develop, implement, and document processes to maintain high data quality standards.
• Utilize data sources to analyze and update operational strategies.
• Be responsible for the design and presentation of critical metrics to leadership.
• Support REMS operational activities and projects for new product launches and development of new REMS programs.
• Identify opportunities for leveraging REMS materials, processes and repositories to drive alignment, consistency and operational efficiency across products, indications, and the Commercial team.

Benefits

• Annual base salary for this position ranges from $ 193,898.40 - 290,847.60 USD Annual
• AstraZeneca is committed to providing fair and equitable compensation opportunities to all colleagues.
• Our compensation policies and practices have been designed to allow colleagues to progress through the salary range over time as they progress in their role.
• The range provided in this posting represents an offer pay range used in a majority of situations.
• The base pay offered will vary depending on multiple individualized factors, including the candidate's skills and experience, job-related knowledge, and other specific business and organizational needs.
• In some cases, offers outside the range may also be considered to address unique circumstances.
• In addition, our permanent positions offer an annual Variable Pay Bonus/Short Term Incentive opportunity as well as eligibility to participate in our equity-based long-term incentive program (if applicable to role).
• Benefits offered for permanent roles include a competitive Flex Benefits & Retirement Savings Program, 4 weeks’ paid vacation, and annual Personal Days.
• Fixed Term Contract/Temporary positions (excluding students) are offered a Contract Benefits Program.

What This Job Offers

• Job Type: Full-time
• Career Level: Director