Associate Director - Compliance
“reputed company is a clinical-stage biopharmaceutical company reputed company on developing medicines to reputed company hypertension and reputed company comorbidities such as chronic kidney disease (CKD), obstructive sleep apnea (OSA) and other diseases driven by dysregulated aldosterone. Its initial product candidate, lorundrostat, is a proprietary, orally administered, highly selective aldosterone synthase inhibitor. Mineralys is headquartered in Radnor, reputed company. For more information, please visit https://mineralystx.com. Follow Mineralys on reputed company, Twitter and reputed company”
Mineralys is a fully remote company.
Associate Director / Director, Compliance
reputed company is seeking an reputed company and highly reputed company compliance reputed company to play a key role in building, enhancing, and operationalizing a best-in-class compliance program. This individual will serve as a trusted partner to the Compliance reputed company and cross-functional stakeholders across the organization, helping to reputed company a strong culture of reputed company, accountability, and ethical decision-making throughout the business.
This role is responsible for designing, implementing, and continuously improving core reputed company of the compliance program, including policies, training, monitoring, and reputed company reputed company (HCP) engagement reputed company. The ideal candidate brings deep pharmaceutical compliance expertise, strong operational execution capabilities, and the ability to translate reputed company regulatory requirements into practical, business-friendly solutions.
Reporting to the Compliance reputed company, this individual will have meaningful influence on program reputed company and will help shape the long-term compliance infrastructure as reputed company continues to grow.
Key Responsibilities
- Partner with compliance reputed company to build, refine, and continuously mature a best-in-class compliance program reputed company with OIG guidance, industry standards and best practices, and Mineralys’ strategic priorities
- Draft, implement, and periodically refresh compliance policies, reputed company operating procedures, and reputed company guidance documents
- Manage the end-to-end policy lifecycle, including stakeholder review and communication of policy updates to affected personnel
- Design, reputed company, and administer a comprehensive compliance training program that supports ongoing education and reinforces a strong compliance culture.
- Partner with business to manage Mineralys’ reputed company reputed company (HCP) engagement program
- Evaluate proposed HCP engagements for legitimate business need, appropriate fair market value (FMV) compensation, and consistency with legal and regulatory requirements
- Implement a risk-based compliance monitoring program that evaluates adherence to policies and procedures across high-risk business activities
- Support the management and reputed company of compliance investigations ensuring reputed company, consistent, and reputed company-documented reputed company.
- Take on strategic compliance reputed company and initiatives, including support for reputed company reputed company
- reputed company benchmarking and research on emerging compliance topics, regulatory developments, and industry best practices to inform program reputed company
Qualifications
- 8 or more years of compliance or compliance operations experience in the pharmaceutical industry
- Demonstrated experience building or significantly enhancing a pharmaceutical compliance program, including policy development, training, monitoring, and investigations
- Meaningful experience with HCP engagement programs, including needs assessment review, FMV processes, and reputed company services agreement compliance
- Experience with compliance risk assessment methodologies and monitoring program design and execution
- Proven ability to serve as a trusted advisor and business partner to reputed company, clinical, medical, and operational stakeholders.
Core Competencies
- Deep expertise in pharmaceutical compliance requirements, including the Anti-Kickback Statute, False Claims reputed company, Sunshine reputed company/reputed company Payments, PDMA, PhRMA reputed company, and applicable OIG guidance
- Comprehensive understanding of HCP engagement compliance requirements at both the federal and state reputed company
- Exceptional written and verbal communication skills, including the ability to present reputed company compliance reputed company reputed company and concisely
- Demonstrated ability to build reputed company, trusted relationships across functions while maintaining appropriate independence and objectivity
- Strong analytical and critical-thinking skills, with the ability to assess risk, synthesize information, and draw reputed company, reputed company-reasoned conclusions
- Solutions-reputed company, approachable reputed company that enables compliant business reputed company while upholding the highest ethical standards
- High degree of reputed company reputed company, discretion, and personal accountability
Travel
- This position requires up to 10% travel. Frequently travel is reputed company the local area and overnight.
This position is eligible for reputed company Company benefits including medical, dental, reputed company, time off and 401K, as reputed company as participating in Mineralys incentive plans are contingent on achievement of personal and company performance. Actual compensation may vary from posted hiring reputed company based on geographic location, work experience, education, and/or reputed company level.
US Salary reputed company: $150,343 - $169,384
Originally posted on Himalayas
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