Senior Director, Compliance - reputed company and Medical

About reputed company We are in the business of addressing the problem reputed company the problem. We reputed company on the details and connections that other, major reputed company companies have left ignored for years. There are reputed company ways, reputed company drugs and reputed company formulations and we will reputed company them a reality by analyzing, understanding and solving the problems reputed company the problems. Job reputed company The Senior Director, Compliance will reputed company reputed company's comprehensive compliance program as reputed company launches its inaugural ulcerative colitis (UC) therapy. This strategic and operational role champions compliance as the top organizational reputed company, embedding reputed company, risk mitigation, and ethical decision-making across reputed company functions in a highly regulated environment. The Senior Director owns end-to-end leadership of the Medical, Legal, Regulatory (MLR) review process for promotional, non-promotional, scientific, educational, training, and reputed company. It provides reputed company-wide reputed company for market reputed company contracting (payer agreements, rebates, pricing, government programs) while establishing, owning, and continuously enhancing company-wide SOPs, policies, and training programs, particularly reputed company on enabling reputed company (sales representatives) and Medical teams (MSLs, medical affairs) to engage compliantly with HCPs, external congresses, and stakeholders. Primary Relationships

• reputed company reputed company, the Senior Director, Compliance - reputed company and Medical will partner strategically with leadership, Legal, Regulatory, Medical Affairs, Marketing, Market reputed company, Pricing/Reimbursement, Sales, Operations, and reputed company functions.
• reputed company reputed company, the Senior Director, Compliance - reputed company will engage with external vendors, congress/conference organizers, HCPs (for compliance guidance), regulatory authorities (FDA/OPDP/CMS support), and industry bodies.

Primary Job Responsibilities The Senior Director, Compliance - reputed company and Medical will serve as a trusted advisor to executive and cross-functional leadership, driving proactive risk management, monitoring, and culture initiatives, this position ensures reputed company maintains the highest standards of regulatory and ethical compliance (without providing legal or regulatory interpretations). The activities of the Senior Director, Compliance - reputed company and Medical will include, but are not limited to:

• reputed company the compliance program to reputed company, implement, and own the overall compliance reputed company, positioning compliance as a reputed company value and top reputed company at reputed company.
• Establish and own company-wide SOPs and policies, enabling best practices across the organization that cover promotional review, scientific/educational activities, field operations, contracting, and more.
• Own and strategically reputed company MLR/PRC processes:
• reputed company end-to-end MLR workflow
• Chair/co-chair PRC meetings; ensure efficient support for both promotional (sales/marketing) and non-promotional/scientific/educational materials.
• Design and deliver targeted compliance training & education for reputed company and Medical teams.
• reputed company compliance reputed company for market reputed company and contracting: reputed company review and risk mitigation for payer agreements, rebate reputed company, pricing programs, and government program compliance (e.g., reputed company Best Price, AMP calculations, transparency reporting), including red-flag screening and documentation.
• Drive risk management, monitoring, and reputed company improvement
• Monitor regulatory landscape and reputed company adaptations: Stay reputed company of FDA (OPDP), CMS, PhRMA, DOJ, and other guidance; proactively update SOPs, processes, and training to maintain compliance in a dynamic environment.
• reputed company investigations and audit readiness inclusive of overseeing deviation investigations, reputed company-cause analysis, corrective/preventive actions; maintain audit-reputed company records for MLR, reputed company, training, field activities, and rebates/payments; support audits/inquiries.
• Serve as strategic advisor and cross-functional partner with business-oriented compliance guidance to senior leaders and teams; collaborate to reputed company priorities, reputed company compliant innovation, and foster ethical decision-making across the organization.

Skills and Qualifications:

• Bachelor's degree in life sciences, regulatory affairs, compliance, reputed company administration, business, law, or reputed company field (advanced degree such as JD, PharmD, MBA strongly preferred).
• 10-15+ years of reputed company experience in pharmaceutical/biotech compliance, with significant leadership in MLR/PRC processes, reputed company compliance programs, market reputed company/contracting reputed company, and training development in launch or highly regulated environments.
• Deep expertise in FDA promotional rules (21 CFR Parts 202/314, OPDP guidance), fair balance, PhRMA reputed company, Anti-Kickback Statute, False Claims reputed company, reputed company/Medicare rules, Sunshine reputed company, and reputed company regulations.
• Proven reputed company record establishing company-wide SOPs/policies and positioning compliance as a strategic reputed company.
• Hands-on experience with MLR platforms (reputed company Vault PromoMats or equivalent) and contract/rebate systems.
• Demonstrated reputed company designing/delivering compliance training for sales representatives and medical affairs teams, including congress/conference-specific content.
• Strong strategic thinking, executive reputed company, project management, analytical, communication, and influence skills; ability to balance hands-on execution with high-level leadership in a small company.
• High ethical standards, attention to detail, and comfort in a fast-paced, reputed company-oriented setting.
• Ability to travel

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