What are the responsibilities and job description for the Compliance Specialist (Life Sciences) position at Kaav Inc?
Job Title: Compliance Specialist (Life Sciences)
Location: Fort Worth, TX 76177 (Hybrid – 3 Days Onsite / 2 Days Remote)
Travel: None
Job Description
We are seeking a Compliance Specialist to support healthcare compliance operations, transparency reporting, and Healthcare Professional (HCP) engagement activities for a leading Life Sciences organization. This position will partner closely with the Operations Senior Manager to execute compliance programs, maintain reporting requirements, and support continuous process improvements.
The ideal candidate will have 2–5 years of experience within the Pharmaceutical, Medical Device, or Life Sciences industry and possess exposure to healthcare compliance, transparency reporting, HCP engagements, or related operational functions.
Key Responsibilities
Transparency Reporting & Compliance Operations
- Support U.S. Sunshine Act/Open Payments and state transparency reporting requirements.
- Collect, validate, reconcile, and maintain HCP transfer-of-value data.
- Assist with reporting submissions, dispute resolution, audits, and documentation.
- Monitor changes in federal, state, and global transparency regulations.
- Improve reporting processes, controls, and data quality.
HCP Engagement Support
- Support physician engagements, speaker programs, advisory boards, consulting agreements, and educational events.
- Partner with Commercial, Medical Affairs, Finance, and IT teams on HCP engagement processes.
- Assist with system testing, workflow validation, and user support.
- Monitor HCP engagement activities for compliance adherence.
Compliance Monitoring
- Review payments, contracts, and supporting documentation.
- Support compliance monitoring activities and corrective action tracking.
- Identify compliance trends and process improvement opportunities.
Due Diligence & FMV Support
- Conduct due diligence reviews for HCPs, HCOs, and related entities.
- Maintain due diligence records and risk assessment documentation.
- Support Fair Market Value (FMV) processes and documentation requirements.
- Coordinate with internal stakeholders and third-party vendors.
Program Support
- Assist with SOP development, training materials, job aids, audits, and compliance initiatives.
- Collaborate with cross-functional teams to support compliance programs and operational excellence.
Required Qualifications
- Bachelor's Degree required.
- 2–5 years of experience in:
- Healthcare Compliance
- Transparency Reporting
- Compliance Operations
- Life Sciences Operations
- Experience within Pharmaceutical, Medical Device, or Life Sciences organizations.
- Understanding of:
- U.S. Sunshine Act / Open Payments
- HCP Engagements
- Compliance Monitoring
- Regulatory Requirements
- Strong analytical, organizational, and communication skills.
- Proficiency with data analysis, reporting systems, and documentation management.
Preferred Backgrounds
- Pharmaceutical Industry
- Medical Device Industry
- Biotechnology / Life Sciences
- Medical Education
- Commercial Operations
- Regulatory Affairs
- Training & HCP Engagement Programs
Not a Fit
Candidates with experience limited to:
- Hospital Compliance
- Healthcare Providers
- Insurance Companies
- General Healthcare Administration