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With 226 days of sunshine, 1.2 million acres of breathtaking scenery of the Black Hills National Forest, 700 miles of motorized trails and nearly 500 miles of hiking trails, there is a lot to see and do.
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Providing comprehensive and high-quality legal support in the areas of sales, marketing, promotional/medical/patient materials, patient access/support/reimbursement, government contracts and pricing, managed care, fraud & abuse, and regulatory and legal compliance with federal and state statutes, FCPA, rules and regulations, privacy, safety/product liability law, and other laws, regulations and Company policies and procedures.
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Proactively support organizational goals and objectives, policies and procedures, and FDA regulations including strict compliance with AquaBeam's Customer Relationship and the Sunshine Act policies.
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Thorough knowledge of pharmaceutical/biotechnology industry and laws, regulations, and guidelines applicable to the development and commercialization of medicinal products, including the Food, Drug and Cosmetic Act, Anti-Kickback Statute, False Claims Act and the Physician Payments Sunshine Act.
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Maintain trained status for, and comply with, all relevant aspects of the PROCEPT BioRobotics Quality Management System to ensure product and support regulatory compliance. Aquablation therapy combines real-time, multi-dimensional imaging, automated robotics and heat-free waterjet ablation for targeted, controlled, and immediate removal of prostate tissue.
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The Trade Control Specialist is responsible for monitoring and auditing the systemic processes in SAP GTS to ensure compliance with GTC requirements and to develop corrective action plans with the GTC Control Tower, plants, and markets to address compliance gaps.
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Provide customer training in the implementation of those systems in compliance with company standards and procedures, and government regulations (SOPs, GMPs, GLPs, PSM, etc. Sunshine ActPfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations.
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Ownership for completion of sunshine reporting, quarterly footnotes and other corporate reporting compliance. Partner with functional and intercompany teams as needed to support finance activities including corporate reporting deliverables, policy compliance, and process improvements.
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Objective Our Tax Service department is seeking an experienced Tax Compliance Manager to review and ensure our clients' tax filings are following government and local regulations. You will also work with a team of friendly staff in a comfortable office full of sunshine.
$100,000 - $150,000 a yearExpandUpdated 3 days ago - UpvoteDownvoteShare Job
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Broad knowledge of and significant legal experience in anti-kickback, Sunshine Act reporting, FDCA, OIG, privacy, FCPA and other statutes, regulations, guidances, enforcement, and trends applicable to the development, marketing and sale of pharmaceutical products, especially the US environment.
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He/she works collaboratively with the coding and compliance departments to ensure appropriate final DRG assignments and CC/MCC capture. Four seasons of sunshine! Fully understands coding compliance regulations and implications to Billings Clinic.
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Understanding of PhRMA, OIG, and ACCME guidelines and policies as well as other regulatory, legal, ethics/compliance guidelines/regulations. Participate in cross functional teams to ensure department and organization comply with all internal and external requirements (i.e. Sunshine, CIA, ACCME, Novartis policy.
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Laws (e.g., FCPA, UK Bribery Act), data protection laws (e.g., GDPR, CCPA), Sunshine Act and other transparency laws. Together with the Chief Ethics & Compliance Officer and other key stakeholders, develop and implement a monitoring and auditing program designed to ensure compliance with internal policies and procedures and applicable laws, regulations and industry guidance and standards.
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Mallinckrodt Pharmaceuticals is required to report certain payments or transfers of value (such as expense reimbursement, meals, transportation) made to U.S.-licensed healthcare professionals in compliance with the federal Physician Payment Sunshine Act (i.e. Open Payments) and certain state laws.
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Actively contributes as part of the ESOQ Tier 2 structure to ensure that Pfizer network of External suppliers / CMO’s / partners are supported to deliver high quality products, on time, and in compliance with all established standards and agency guidelines/applicable GMP regulations.
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