Advisory Manager (Regulatory & Compliance)
Deloitte & Touche LLP seeks a Advisory Manager (Regulatory & Compliance) in Newtown Square, PA.
Work You'll Do
Perform engagement or task management and select appropriate methodologies. Utilize knowledge of Computer Systems Validation, Business Analysis, Regulatory Affairs, Quality Assurance within the Pharmaceutical, Biotech and/or Medical Device companies. Perform implementation and validation of corrective/preventative action (CAPA), complaint handling, laboratory information, enterprise resource planning, manufacturing execution, document management and e-pedigree systems. Utilize knowledge of federal and international GMP regulations (FDA 21 CFR Parts 210, 211, 820, Part 11, ISO, EU, etc.). Play substantive role enhancing relationships with internal resources, attaining quality internal and external communication deliverables including technical content of reports, proposals, etc. Demonstrate knowledge of industry or functional specialty. Play substantive role in engagement planning, economics, and billing. Deliver services that meet organization's engagement leader specifications. Produce material for internal publications. Participate in proposal development efforts. Evaluate, counsel, mentor, and provide feedback on performance of others. Assist in retention of professionals and assist in training efforts. Play substantive role in client relationship and communication.
- Bachelor's degree (or higher) in Computer Science, Information Systems, Math, Computer Engineering, Decision Sciences, Engineering, Risk Management, or related field (willing to accept foreign education equivalent).
- Five years of regulatory compliance experience in the Life Sciences industry and the pharmaceutical industry.
- Experience must include five years of:
- Completing Sunshine implementation and CMS Submissions for the pharmaceuticals industry;
- Architecting systems for reporting and business analytics in Transparency Integration projects;
- Delivering IT solutions by defining compliance IT strategies and programs that align IT portfolios and investments with business priorities and strategic imperatives;
- Implementing projects using Cloud Data Integration and disruptive technologies, including Service Oriented Architectures;
- Monitoring data feeds of HCP spend data from internal and external sources, communicating issues/findings to business units and vendors, and facilitating remediation;
- Providing compliance oversight on Aggregate Spend systems, including helping to identify new business rules, and collaborating with vendor and IT partners to resolve data and operational issues;
- Architecting ETL systems to load data from various sources into Aggregate Spend Reporting databases using Informatica, Informatica Cloud, SOA, SharePoint Portals, Business Objects, and Oracle 10g;
- Completing Federal submission to CMS for healthcare transparency projects;
- Configuring and testing business processes; and
- Planning scope of work, monitoring and reviewing work of junior staff members.
- Must have one of the following: CISSP, PMP, CISM, or CISA certification.
- Position requires approximately 80% travel.
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Requisition code: XSFH18FA0817NEW1
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