Head of Standards, Governance & Transparency, US Commercial - BIO
About The Position
About the Role: The Head of Standards & Governance, U.S. Commercial sits within the Business Insights & Operations (BIO) organization and oversees risk management for U.S. Commercial activities, partnering closely with U.S. Compliance Officers to ensure effective oversight of field and marketing actions. This role provides strategic and operational leadership across speaker programs, HCP meals and engagements, field interactions, and related promotional activities to ensure adherence to federal, state, and industry requirements. This Director level leader owns end‑to-end U.S. Transparency reporting and data governance - driving accuracy, completeness, and timely submission of all required disclosures. They are responsible for maintaining and evolving Commercial and Field compliance policies, developing training that supports compliant behaviors, and proactively identifying and mitigating emerging risks. Through strong cross‑functional collaboration, standardized processes, and data‑driven insights, this role strengthens the organization’s compliance culture and ensures enterprise readiness against regulatory expectations. This position is Hybrid-Cambridge and requires travel three times per week into our Kendall Square offices. What You’ll Do: Oversee compliance with Federal and State Transparency laws through team-managed activities Lead the sub-certification process with VP+ cross-functional leaders in various departments Manage error management and remediation processes Drive data review, reconciliation, and submission to CMS Develop and implement regulatory, legal, and commercial compliance controls Create and provide training and guidance for business practices Support the annual risk assessment and execute risk mitigation plans Serve as the first point of contact for Standards & Governance questions Review compliance dashboards and escalate red flags to US Compliance Support internal and third-party auditing processes Develop and oversee compliance action plans and corrective actions Provide leadership to achieve departmental business results and develop an exceptional workforce Present compliance related topics and updates to senior leadership Who You Are: You are a strategic thinker with a deep understanding of pharmaceutical and biotech compliance landscapes. Your ability to collaborate and lead cross-functional teams ensures effective regulatory adherence and operational excellence. With a keen eye for detail and a proactive approach, you excel at identifying and mitigating risks. You thrive in dynamic environments, balancing multiple priorities while fostering a culture of compliance and transparency.
Requirements
- Bachelor's degree required, MBA or graduate degree preferred
- 10+ years of experience in the Pharmaceutical/Biotech industry
- In-depth knowledge of transparency reporting requirements (Sunshine Act, State Law)
- Deep understanding of data collection and reporting systems supporting reporting requirements
- Familiarity with laws, regulations, and industry guidance affecting the biopharmaceutical industry
- Proven leadership skills with expertise in influencing across a matrix and managing multiple priorities
Nice To Haves
- Experience in overseeing internal and third-party auditing processes
- Strong project management skills with a focus on compliance and transparency initiatives
- Exceptional communication skills to effectively liaise between business units and compliance teams
Responsibilities
- Oversee compliance with Federal and State Transparency laws through team-managed activities
- Lead the sub-certification process with VP+ cross-functional leaders in various departments
- Manage error management and remediation processes
- Drive data review, reconciliation, and submission to CMS
- Develop and implement regulatory, legal, and commercial compliance controls
- Create and provide training and guidance for business practices
- Support the annual risk assessment and execute risk mitigation plans
- Serve as the first point of contact for Standards & Governance questions
- Review compliance dashboards and escalate red flags to US Compliance
- Support internal and third-party auditing processes
- Develop and oversee compliance action plans and corrective actions
- Provide leadership to achieve departmental business results and develop an exceptional workforce
- Present compliance related topics and updates to senior leadership
Benefits
- Medical, Dental, Vision, & Life insurances
- Fitness & Wellness programs including a fitness reimbursement
- Short- and Long-Term Disability insurance
- A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31)
- Up to 12 company paid holidays + 3 paid days off for Personal Significance
- 80 hours of sick time per calendar year
- Paid Maternity and Parental Leave benefit
- 401(k) program participation with company matched contributions
- Employee stock purchase plan
- Tuition reimbursement of up to $10,000 per calendar year
- Employee Resource Groups participation
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What This Job Offers
Job Type
Full-time
Career Level
Director
Number of Employees
1,001-5,000 employees
