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PGS Compliance Counsel
Refer job# HFAO140846
 
PGS Compliance Counsel The candidate will be responsible for the execution of company s Compliance program for colleagues within the company s Global Supply (PGS) organization. Reporting to the PGS Compliance Lead in the GxP Compliance Group. Serves as a compliance advisor to the global PGS organization. At the direction of the PGS Compliance Lead, the PGS Compliance Counsel will be responsible for assisting the PGS organization to maintain a state of compliance including providing training and workshops on company s compliance expectations to PGS sites across the globe; developing communications strategies to establish a tone of compliance and integrity; engaging with the PGS Quality and Compliance Committee and other committees, as applicable, responsible for quality and compliance oversight of PGS; and providing proactive compliance support to key areas within the PGS organization. The PGS Compliance Counsel has a close working relationship with the other attorneys supporting PGS and regular communication and coordination with other Compliance and Legal colleagues, including the REG Law team and the Compliance Investigations, Risk Assessment, Monitoring and Analytics and Policy and Strategic Operations groups within Compliance, as well as with Internal Audit. Implement company s Compliance program for the PGS organization globally at the direction of the PGS Compliance Lead. Analyze compliance related data and trends (e.g. audits, inspections, investigations, etc.) to proactively identify areas of risk. Manage and engage in proactive worldwide compliance activities for PGS colleagues including: training and outreach efforts, including development and/or execution of training curriculum in key areas; assistance in the identification, assessment and mitigation of risk; researching and monitoring emerging trends and changes to the political, legal and regulatory landscape by working with the businesses and other colleagues; implementation of corporate and divisional policies and procedures and the development of group or division-specific guidance or policies as needed; creative thinking to develop additional tools and controls to drive compliance and enhance a culture of integrity; and support compliance certifications required under company s policies and procedures. Coordination of compliance-related communications, including updates to PGS leadership on external enforcement environment activity and other compliance-related issues of importance, including investigation trends involving PGS colleagues and enterprise-wide compliance initiatives. At the direction of the PGS Compliance Lead, management of enterprise-wide risk and the implementation of company-wide controls in key areas including manufacturing quality, supply chain, EHS, import-export control and other key areas by ensuring consistent interpretation of policies/procedures and the development of new policies, procedures, or guidance as needed; engaging in risk assessment activities to identify continuous enhancement opportunities; provide advice and counsel to both process owners in the PGS organization, and serve as subject matter expert for other Compliance Division colleagues (BU Compliance Leads, RCLs, Global Investigations and Risk Assessment group, the Compliance Monitoring and Analytics team, and the Policy and Strategic Operations Team) on these topics. Provide significant support to ensure the effective operation of the PGS Quality and Compliance Committee. Act as liaison to subject matter experts for colleagues in PGS on topics including healthcare law and other compliance topics including HCP engagement, GPIHP, transparency laws, FCPA compliance, conflicts of interest, and support the management of related SOPs and guidance documents, as needed. Work with the Compliance Investigations group to understand the docket of compliance investigations across PGS and monitor trends to report to PGS QCC and support remediation efforts, as needed, and in coordination with the BU Compliance Leads or Regional Compliance leads. Oversee proactive reviews and special projects designed to identify and mitigate compliance risks involving PGS. Provide compliance support for integration or business reorganization activities that impact PGS, as appropriate.

Qualifications: A Bachelor's degree required; Juris Doctor or related advanced degree strongly preferred. Proven capabilities, including 8+ years of law firm and corporate professional experience in advising clients concerning legal and/or regulatory requirements applicable to the manufacturing, GMP, procurement, import (customs), export, international trade, marketing and/or promotion of pharmaceutical and biologics products, services and technologies related to dosage forms and solutions provided to healthcare and related industries. Experience in data analytics preferred. Experience in healthcare compliance, healthcare law and policy, regulatory law, FCPA or other commercial legal or transactions practice preferred. Willingness to travel domestically and internationally. Deadline: October 3, 2018.
 
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