The Compliance Specialist will play a critical role in ensuring that [Company Name] adheres to all regulatory requirements, including those related to field rides, anti-kickback regulations, and FDA compliance. This position will be responsible for supporting the company's compliance programs, performing field monitoring, and working closely with cross-functional teams to uphold legal and ethical standards.
Key Responsibilities:
Field Ride Oversight: Conduct and monitor field rides to ensure compliance with company policies, regulatory standards, and best practices in accordance with healthcare regulations. Provide feedback and recommendations to field-based teams based on observations during field rides.
Anti-Kickback Compliance: Stay up-to-date on anti-kickback statutes and related compliance regulations. Ensure the company is compliant with the Anti-Kickback Statute (AKS), False Claims Act (FCA), and other related laws. Assist in the development of policies and training to mitigate the risk of violations.
FDA Regulations Compliance: Ensure that all company activities, including promotional and marketing practices, are aligned with FDA regulations, including FDA's Code of Federal Regulations (CFR), Title 21, and other applicable regulatory standards. Provide expertise on FDA compliance issues to internal stakeholders.
Policy Development and Implementation: Develop, implement, and update compliance policies and procedures in line with evolving regulations. Work collaboratively with leadership and various departments to promote a culture of compliance across the organization.
Training and Education: Develop and deliver compliance training programs to internal teams on FDA regulations, anti-kickback laws, and other key compliance areas. Educate staff on proper ethical and legal practices within the biotech industry.
Auditing and Monitoring: Conduct regular audits and monitoring activities to assess the company's adherence to compliance policies and regulatory standards. Provide findings and corrective action plans as needed.
Risk Management: Work closely with legal and other relevant departments to identify and mitigate compliance risks. Assist in managing compliance investigations and corrective actions.
Cross-functional Collaboration: Partner with sales, marketing, legal, regulatory, and other teams to ensure compliance with all applicable rules and regulations.
Qualifications:
Education: Bachelor's degree in Life Sciences, Healthcare, Business, or related field. A law degree or certification in compliance (e.g., CHC or CPC) is preferred.
Experience:
- Minimum of 3-5 years of experience in compliance or regulatory affairs, preferably in the biotech or pharmaceutical industry.
- Proven experience with field ride oversight and managing field-based compliance programs.
- In-depth knowledge of Anti-Kickback Statute (AKS), False Claims Act (FCA), and related healthcare compliance regulations.
- Familiarity with FDA regulations and experience ensuring compliance with FDA requirements for medical devices, pharmaceuticals, or biologics.
Skills:
- Strong knowledge of healthcare regulations, including the Anti-Kickback Statute, FDA rules, and industry standards.
- Excellent written and verbal communication skills.
- Ability to develop and deliver compliance training and educational programs.
- Strong analytical skills with the ability to assess risks and recommend solutions.
- Detail-oriented and highly organized with the ability to manage multiple tasks and deadlines.
Other:
- Ability to travel for field rides and audits as required.
- A strong ethical compass and commitment to promoting a culture of compliance.
