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Contracts and Healthcare Compliance Manager
2 months ago
Induce Biologics is commercializing a family of bioimplants that includes Natural Matrix Protein (NMP™) which replicates the body’s native healing capabilities in order to create natural bone regeneration. The NMP™ proprietary process unlocks the growth factors naturally found in bone, making them bioavailable. Induce Biologics USA Inc. is a small business in Irvine, CA. We are professional, agile, and innovative.
The Contract and Healthcare Compliance Manager will be responsible for managing contract negotiations with hospitals, IDNs, and GPOs, ensuring compliance with applicable healthcare regulatory requirements, and mitigating legal risks. This role is critical in supporting the company’s business operations while maintaining adherence to industry standards and regulations.
Healthcare Compliance and Regulatory Management
- Serve as a healthcare compliance manager, ensuring adherence to relevant regulations and standards. Understand business strategy and implement pragmatic controls to manage compliance risk. Conduct compliance risk analyses, identifying potential areas of compliance vulnerability and risk, develop and implement action plans to mitigate potential risks, and follow up on status and effectiveness
- Develop and implement internal controls and policies to ensure compliance with applicable contract and regulatory reporting requirements.
- Implement strategies with leadership to review and identify contract disclosure requirements, ensuring the company meets all state and regulatory disclosures and ordinances. Regularly assess compliance practices and make recommendations for improvements.
- Manage compliance training programs to educate all Induce employees to ensure a comprehensive understanding. Assist in identifying compliance training needs, develop and deliver training to employees to ensure awareness.
- Collaborate closely with colleagues in Legal, IT, HR, Finance, Quality and Regulatory, and other core functions in order to direct compliance issues through the appropriate channels for investigation and resolution, reporting, and remediation.
- Serve as HIPAA and US Privacy Officer for the Company
Contract Management
- Manage and oversee all aspects of contract matters, including the entire lifecycle from request to execution.
- Lead negotiations on Master Agreements and custom templates, ensuring alignment with business goals and mitigating risks.
- Prepare, review, and respond to new contract submissions and amendments, including those with distributors, IDNs, GPOs, and hospital organizations.
- Develop and maintain contract templates, ensuring compliance with company policies and legal requirements.
- Independently perform first-pass redline responses, using approved processes to mitigate risks.
- Regularly audit and maintain comprehensive contract records to ensure compliance with legal standards and company policies.
- Monitor contract performance, tracking key milestones, deliverables, and payments to ensure all obligations are met.
- Serve as the primary contact for resolving contract escalations, ensuring swift and effective resolution.
- Lead process improvement projects to enhance operational efficiencies and standardization across the organization.
Education/Experience Required
- Bachelor's degree in Business Administration, Legal Studies, or relevant field
- Experience in contract management, preferably in a similar industry or organization
- 5 + years of experience in biotech/pharma drafting and negotiating a wide variety of contracts
- Must have experience with the healthcare contracting landscape, including knowledge of Group Purchasing Organizations (GPOs), Integrated Delivery Networks (IDNs), or experience within the medical device industry
Skills, Knowledge, and Abilities
- Thorough understanding of contract law, including formation, interpretation, and execution
- Full knowledge of medical terminology and healthcare regulations (e.g. HIPAA and Sunshine Act)
- Strong negotiation skills with a focus on achieving favorable terms while nurturing positive relationships and achieving win-win outcomes
- Strong knowledge of contract law and legal principles
- Evidence of strong strategic thinking, analytical, planning, and organizational skills.
- Strong communication skills, both written and verbal, with the ability to effectively communicate complex information to stakeholders at all levels
- Proficient in using contract management software or tools