Job Details

Manager Compliance Monitoring And Risk Management

Company name

Shire.

Organization Type

In-House

Job Type

Non-practicing Attorney

Date Last Verified

Aug 16,2018

Posted on

Jul 31,2018

Years of Experience

Min 5 yrs required

Location

Lexington, MA
Practice Area
Health Care >> Health Care
Intellectual Property >> Intellectual Property - Patent >> Intellectual Property - Patent - Life Sciences >> Biotechnology
Intellectual Property >> Intellectual Property - Patent >> Intellectual Property - Patent - Life Sciences >> Pharmacology
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Manager, Compliance Monitoring and Risk Management The candidate will be responsible to support Global Compliance and Risk Management (GCRM) objectives, processes, and systems used to implement an effective U.S. Compliance program with respect to compliance monitoring, risk assessment, and management/mitigation of risks. Will assist with the development and implementation of the U.S. compliance monitoring program to evaluate firm’s adherence to company policies and procedures. Establish monitoring plans and procedures, create systems for evaluating, tracking, and reporting findings, and collaborate with GCRM Business Partners and other functional leaders to implement preventative and corrective action plans. Work closely with third party monitoring partners to assist with provision of required information, provide direction as needed to help ensure monitoring activities are completed as planned, and understand the basis for monitoring findings. Perform sales representative field ride and speaker program monitoring, as well as other monitoring tasks as assigned. Prepare summary reports of monitoring outcomes for GCRM and other business leaders as required. Organize and retain compliance monitoring records in GCRM systems. Support the development and implementation of the U.S. Risk Management process, including providing input to risk assessments, maintaining accurate and updated risk information in the RAMP database, and documenting risk mitigation strategies and corrective actions. Manage the intake process for capture of U.S. compliance issue reports, including entry of cases into SharePoint and EthicsPoint and follow-up with Compliance Assurance and other GCRM staff to ensure cases are addressed in a timely manner. Regularly compile metrics and provide insightful reports to summarize reported issues and case status.

Qualification and Experience

The candidate should have BS/BA degree. Should have 5+ years of broad experience in biotech/pharmaceutical industry and/or with pharmaceutical manufacturer. Should have 5+ years of direct healthcare compliance monitoring and risk management experience, with practical experience in interpretation of relevant industry regulations and guidance documents. Experience multi-tasking, managing multiple projects, and meeting deadlines is essential. Juris Doctorate degree is essential. Certification in Healthcare Compliance Law is essential. Licensure or certification in auditing or accounting is essential. Must have experience with Concur, QlikSense/Tableau, EthicsPoint. Knowledge of relevant healthcare compliance laws (i.e., AKS, FCA, FDCA, FCPA, PDMA) is essential. Critical thinking and analytical skill is essential. Proficiency in Microsoft Office is required (i.e., Word, Excel, PowerPoint) is essential. Writing, reporting, and analytics skill is essential.

Additional info

Ref. R0025486

Company info

Hiring Coordinator
Shire.
300 Shire Way
Lexington, MA 02421

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