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Role Overview (Hybrid 2 days in office/3 days work from home)
Company is seeking an experienced healthcare compliance professional to take a role in designing,
implementing, building, and maintaining an effective US healthcare compliance program and
developing a culture of compliance in the organization. This individual will support a growing
business and shape the company culture to achieve the company’s goals and objectives in a
compliant and ethical manner. The ideal candidate will work across the business to set the tone
and trajectory of the compliance program while meeting applicable healthcare-related laws, rules,
regulations, guidance requirements, and internal policies.
Primary Duties & Responsibilities
Key contact point for US compliance
Chair and oversight of the Compliance Committee
Serve as the Company Compliance Officer
Develop strategies for, and oversee day-to-day operations of, Company’s’ compliance and ethics
program
Develop, update, and execute implementation of right-sized policies, procedures, and ways
of working
Staying current with relevant rules and regulations
Develop training programs and communications to help employees understand their role in
maintaining a compliant and ethical organization
Proactively identify compliance risks, opportunities and mitigating actions
Create, update, and manage a risk-based compliance auditing program, including monitoring
of commercial activities, ride-along with sales representatives, and review of HCP
interactions, drug sample accountability, etc.
Manage investigations into possible violations of applicable laws, rules, regulations, and
policies and recommend a corrective and preventive action plan (CAPA).
Manage and coordinate with internal stakeholders, vendors, and third parties on federal and
state transparency (Aggregate Spend) and transfer of value (gift bans) reporting, field
1
representative registration, sample accountability, and compliance program reporting
requirements.
Ensure timely submission of aggregate reports and required disclosures
Fair Market Value (FMV) assessment for healthcare professionals (HCP)
Subject matter expert providing advice on compliance matters including but not limited to,
labelling, marketing strategies, promotional tactics and materials, advertising campaigns and
programs, patient support programs, customer interactions, HCP engagements, and
commercial sponsorships.
Compliance oversight of investigator-initiated trials (IITs), advisory boards, and speaker
programs.
Competencies/Career level
Please list all that apply: Innovation, entrepreneurial attitude, customer orientation, team
leadership, adaptability/flexibility, results-oriented, control of budgets/costs, Self-development.
Requirements and personal skills
• Education: Bachelor’s degree required; JD, MBA, MPH, or Master’s in a related field
preferred
• Languages: English
• Experience (years/area): 7 to 10 years’ related experience in a biotechnology or
pharmaceutical company. Tactical, operational, and strategic capability is preferred
• Specific Knowledge and abilities: Broad knowledge of US compliance and data privacy
laws and standards, including but not limited to Open Payments Sunshine Act, OIG HHS
Compliance Program Guidance, PDMA, HIPAA, and GDPR.
State level privacy, compliance and transparency laws.
Federal False Claims act, Federal anti-kickback statute, PhRMA Code.
Demonstrated ability to lead teams, influence stakeholders, and manage complex
compliance issues.
High ethical standards and sound judgment.
Phone
Job Type
Remote Status
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