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

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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.