With my expert knowledge and experience, I can help your organization with a variety of information governance and records management projects and tasks. We will collaborate to build solutions that will enable opportunities to remove costs and risks. Having spent 27+ years in the pharmaceutical industry, my work delivers the highest quality expected by both domestic and international regulatory agencies and legal authorities. Here are some of the things we can deliver:Information and records management policies, strategic plans, and governance models.Retention and destruction rules and schedules for paper and electronic records, including databases, digital documents, email, and social media.Evaluations of IG and RIM program, gap analysis, benchmarking, and cost/risk analysis based on international standards, compliance requirements, and best practices.Studies to determine feasibility and business cases for records management application (RMA) software, electronic archiving systems, and digital document imaging/conversion initiatives.Budgets, cost estimates, and cost justifications for IG and RIM operations and projects to present for executive-level approval.Information integration analysis and plans resulting from mergers, acquisitions and divestments to assure chain of custody for information ownership upon transfer or migration.Decommissioning projects jointly executed by Information Owners, IT, RIM/IG and Legal so that only what is required is migrated or transferred (for both paper and electronic information) and disposition by policy or mandates (such as Legal Hold) is upheld.

Developed and implemented new global records and information management program globally sponsored by General Counsel.Defined business case and implemented project for a multi-million dollar eArchiving solution for structured and unstructured information to assure compliance to RIM Policy Framework, long term preservation of critical business records and achieve synergies through approved disposition of information with no retention obligation. Created Information Governance Council to gather expertise from RIM, IT, Security, Compliance, Legal, HR and others to create awareness and education on IG matters and define collaborative solutions for information lifespan management.Authored all RIM Policies, Standards, and Job Aids within the Quality Framework and aligned to other Quality groups across the company. Produced and delivered 20-minute interactive online training module for global audience in 11 languages.Defined and implemented new process for integration of paper and electronic information resulting from acquisitions and divestments to assure chain of custody and improve efficiency in records transfers.Performed legacy remediation actions in US and EU resulting in approved disposition of redundant, outdated or trivial materials.Negotiated new offsite records storage contract to consolidate vendors in the US at multiple sites.

Founding member. Provided leadership for this consortium of 15 pharmaceutical companies on various projects. Co-authored a standard Records Retention Schedule for pharmaceuticals. Participated on working groups for standards pertaining to email management, performing legacy remediation and gaining endorsement for information governance initiatives (business case development).

Directed the strategy and performance of the function to maintain overall responsibility for the development, implementation and maintenance of the full global records management program. Provided leadership for operational archiving functions executed through a matrix of regionally organized global Central Site Archives within the function and oversight for business unit Archives and Records Management operations across the company; accountable for the global records management application (TRIM). Full accountability for the 34 employees (including 5 managers) within the function and an annual budget of $8M.Delivered Electronic Archive Service to all global functions to enable decommissioning of systems with proper disposal or archiving and lifecycle archiving for live systems according to the Global Retention and Disposal Schedule. Executive sponsor for the 3-year, $13M global project that delivered the eArchive Service in 2009 (a unique solution within pharma globally). Annual savings to AZ is $5M-$6M.Led global change programs to reorganize 3 regional archive entities reporting to 3 different functional areas into a global function for highest efficiency and to meet restructure challenges from executive level. Delivered reduction of 10 FTE globally for tangible savings of $2M annually.Headed a 2-year project to gain approval from CEO and his Senior Executive Team with engagement to the + 1 level to establish the new Enterprise Information Management organization in IS and the inclusion of Good Information Practice principles in global policies for the company.

Directed a group of 3 managers and 12 staff responsible for regulated documentation in a central archive. Primary collections include all clinical and regulatory affairs documentation, technical reports and laboratory notebooks.Oversaw document conversion processes to digitize archive collections.Acted as Team Leader for document management process excellence project (12 team members) to improve clinical documentation/archival practices to ensure compliance and to develop strategic direction for electronic document management practices. Project completed as part of Process Excellence/Green Belt training.Delivered enterprise-wide Documentum repository for the archival storage and access of imaged and source electronic documents.

Managed 2 US and 2 UK groups (about 40 staff) overseeing worldwide functions for all records created during clinical phase of drug development requiring long term retention. Led project to harmonize policies and procedures in new merged organization for compliance and efficiency.Managed staff responsible for processing and imaging case report forms and data resolution queries for all active clinical studies in North America prior to archiving. Maintained service level agreements within agreed timelines and according to quality specifications. Completed the Request for Proposal process and vendor selection for $1.5 million outsourcing of all contract staff to exclusive agency. Oversaw project to document all departmental processes and approved 15 new guidelines.