HCP Compliance Auditing, Monitoring and Transparency Reporting Consultant (Contractor) - Emeryville, CA | Biospace
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HCP Compliance Auditing, Monitoring and Transparency Reporting Consultant (Contractor)

Santen, Inc.

Location:
Emeryville, CA
Posted Date:
2/9/2017
Position Type:
Consultant, Contract
Job Code:
FY16-80
Salary:
open
Required Education:
Bachelors Degree
Areas of Expertise Desired:

Job Description

HCP Compliance Auditing,  Monitoring and Transparency Reporting (Contractor)

Compliance auditing and monitoring responsibilities:
•   Implement and manage centralized HCP event management database to track, monitor and audit HCP interactions; Prepare comprehensive analyses and summary reports of monitoring activities to proactively identify areas for business enhancements and/or non-compliance with regulatory guidelines, company policies and/or written standards and to uncover/detect patterns of misconduct/fraud; communicate recommendations for corrective action and preventative action plans and remediation to business
•   Develop audit and monitoring annual work plan, reporting templates and reporting tools
•   Lead and conduct internal risk assessments and conduct corresponding audits across all depts where HCP interactions exist
“Sunshine” Transparency Reporting & Gift Ban responsibilities:
•   Lead and implement aggregate spend reporting project to meet U.S. Federal Sunshine Act reporting requirements—leading cross functional team of key stakeholders to implement technical systems (aggregate spend database, modifications to SAP and Concur) and implementing business processes to comply with tracking and reporting requirements
•   Develop policies and business processes (partnering with business stakeholders) to collect, track, and accurately report data to comply with state, federal, and international transparency reporting and gift ban laws
•   Responsible for all leading, tracking and reporting efforts across all business depts to collect necessary data for tracking purposes

Requirements

Bachelors Degree in business, finance, healthcare, biology or law
Juris Doctor (JD) preferred, but not required
CHC (healthcare compliance certification), CIA (internal auditor certification) preferred, but not required
10+ years in the pharmaceutical/medical device industry
5+ years in a compliance auditing and monitoring role
5+ years leading cross-functional teams with proven results
5+ years developing operational policies and procedures that are effective, while also being operationally efficient
3+ years managing and tracking HCP transparency reporting and gift ban tracking and reporting requirements
Must have ability to interpret laws and regulations and analyze case law