Healthcare Compliance Manager
PharmaEssentia Corporation is a rapidly growing biopharmaceutical innovator. We are leveraging deep expertise and proven scientific principles to deliver effective new biologics for challenging diseases in the areas of hematology and oncology, with one product approved and a diversifying pipeline. We believe in the potential to improve both health and quality of life for patients with limited options today through the combination of rigorous research and innovative thinking. Founded in 2003 by a team of Taiwanese-American executives and renowned scientists from U.S. biotechnology and pharmaceutical companies, today we are listed on the Taiwan Stock Exchange (TWSE: 6446) and are expanding our global presence with operations in the U.S., Japan, Singapore, South Korea, and China, along with a world-class biologics production facility in Taichung.
The Healthcare Compliance Manager is a key member of the U.S. Legal and Compliance team, reporting to the Associate Director of Compliance. This role supports the execution and continuous improvement of an effective healthcare compliance program aligned with U.S. laws, regulations, and industry standards. This position operates at the intersection of compliance and the business—serving as a trusted advisor and proactive partner to cross-functional teams. The ideal candidate will be comfortable working independently, navigating complex situations, and using data and insights to strengthen and evolve the compliance program. The role also offers room to develop, with opportunities to take on increasing responsibility and ownership of projects or programs. This is a hybrid role (up to 3 days in office) based in Burlington, MA, with up to 15% U.S. travel.
Key Responsibilities
- Act as a day-to-day compliance partner to business functions including Sales, Marketing, Market Access, Medical Affairs, Patient Advocacy, and Corporate Communications, providing practical, risk-based guidance
- Support the development and implementation of compliance policies, SOPs, procedures, and corporate guidance, ensuring clear and consistent communication across the organization
- Drive compliance training and communications, including development, delivery, and tracking of training programs aligned to current regulatory requirements and business needs
- Support core compliance processes and monitoring and auditing activities—including needs assessments—by reviewing requests, validating documentation, identifying and escalating risks, and partnering with business stakeholders on timely resolution and remediation
- Support internal investigations, including documentation, root cause analysis, and tracking of corrective and preventive actions
- Leverage compliance data, metrics, and transparency reporting to identify trends, risks, and opportunities and to inform compliance priorities, training focus areas, and process improvements
- Collaborate with Legal, Compliance, and global stakeholders on program and operational activities, including ex-U.S. affiliate interactions, vendor management, and Secretary of State filings
Core Competencies
- Strong communication skills, with the ability to translate complex regulatory requirements into clear, practical guidance
- Demonstrated ability to work cross-functionally and build trusted relationships across a matrixed organization
- Analytical mindset with the ability to use AI and data to identify trends, assess risk, and inform decision-making
- Strong attention to detail and commitment to documentation and audit readiness
- Ability to manage multiple priorities and operate effectively in a fast-paced environment
- Sound judgment and the ability to handle sensitive and confidential information with discretion
Qualifications Required:
- Bachelor's degree in a related field
- 2–5 years of experience in the pharmaceutical, biotechnology, or healthcare industry
- Working knowledge of key healthcare compliance laws and regulations, including PhRMA Code, Anti-Kickback Statute (AKS), False Claims Act (FCA), Sunshine Act / Open Payments, FDA regulations, and OIG Compliance Program Guidance
Preferred:
- Certification in Healthcare Compliance (CHC) or a related credential
Fluency or professional proficiency in a second language, particularly Mandarin Chinese
The expected salary range for this position based on greater Boston, MA location is $114,240-$147,900. Actual salary pay will be based on multiple factors, including geographic location, experience, qualifications, and other job-related factors permitted by law. Benefits of working with our team: PharmaEssentia USA strives every day to improve the lives of patients as well as our employees. As a valued member of PharmaEssentia USA, you will enjoy the following benefits:
- Comprehensive medical coverage
- Dental and vision coverage
- Generous paid time-off
- 401(k) retirement plan with competitive company match
- Medical & Dependent Care Flexible Spending Account
- Up to $150 monthly cell phone reimbursement
- Employee Assistance Program