Associate Director, Governance & Operations

AstraZenecaWilmington, DE
Hybrid

About The Position

The Associate Director, Governance & Operations plays a critical role in enabling compliant, high‑quality execution of Market Access engagements across AstraZeneca’s U.S. business. This position serves as the operational owner and Secretariat of the Advanced Customer Engagement Review Team (ACERT), overseeing governance processes that ensure alignment with regulatory expectations, Fair Market Value (FMV) standards, contracting policies, and internal quality controls. This role partners deeply with Market Access, Medical Affairs, Commercial, Access Strategy, Compliance, Legal, Finance, Service Strategy, and external vendors to ensure all programs, engagements, and analytics are appropriately evaluated, documented, and executed. In addition, the leader oversees FMV methodologies, program‑level analytics, and CMS Physician Fee Schedule (PFS) rule–aligned documentation, including Reasonable Assumptions and certification requirements.

Requirements

  • Bachelor’s degree required
  • 5+ years of experience in pharmaceutical, biotech, Market Access, contracting, compliance, or related field.
  • Strong working knowledge of FMV, BFSF criteria, Anti‑Kickback/Safe Harbor principles, and pharma regulations.
  • Proven ability to lead cross‑functional governance teams and influence without authority.
  • Demonstrated analytical capabilities, including cost modeling, data interpretation, and decision rationale framing.
  • Excellent communication, relationship‑building, and critical‑thinking skills.
  • High proficiency in MS Excel, PowerPoint, and Word.

Nice To Haves

  • 5+ years of pharma or healthcare industry experience
  • Strong project management, leadership, business acumen, and ability to manage multiple priorities, processes, timelines and expectations of multiple stakeholder groups
  • Strong interpersonal skills and excellent verbal and written communication skills; able to engage with leadership at all levels of the organization; able to synthesize and concisely communicate team deliverables and accomplishments
  • Experience with marketing operations including strategic oversight and execution of speaker bureau programs; strong comprehension of the legal and regulatory landscape in pharmaceutical promotions, pharma industry guidelines, and compliance considerations

Responsibilities

  • Serve as Secretariat and operational lead for ACERT, ensuring timely, compliant, and high‑quality governance reviews.
  • Advise program owners on business proposals and determine the appropriate review complexity and governance pathway.
  • Lead the FMV evaluation framework, including oversight of analytic processes, vendor reports, and interpretation of data to support FMV decisions.
  • Provide guidance to contracting teams to ensure governance decisions translate into compliant contract execution.
  • Maintain robust audit‑ready documentation, including FMV analyses, decision rationales, and approval artifacts.
  • Identify opportunities for cost savings through use of FMV tools and leveraging prior FMV reports through vendor
  • Oversee governance alignment with CMS PFS rule requirements related to Service Agreements, including certifications and reasonable assumptions documentation.
  • Establish and maintain enterprise standards for documenting assumptions used in valuations, cost analyses, and engagement justifications.
  • Partner with Legal, Compliance, and business sponsors to ensure all certifications are complete, accurate, and updated in accordance with CMS requirements.
  • Conduct training and develop guidance materials to ensure consistent understanding across stakeholders.
  • Maintain centralized governance repositories to ensure completeness, accuracy, and readiness for internal/external audits.
  • Lead the development, update, and communication of governance processes, systems, policies, templates, training tools, dashboards, and analytic frameworks.
  • Provide subject‑matter expertise on Bona Fide Service Fees (BFSF), Anti‑Kickback and Safe Harbor regulations, and other compliance standards.
  • Own and manage relationships with external FMV vendors to ensure high‑quality deliverables, clear SLAs, and adherence to governance standards.
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