Steve Shimek Email & Phone Number

San Diego County, California, United States

Irvine CA

• Managed the Mergers, Acquisitions, Divestiture, Alliances and Partnerships program as it pertained to Research and Develop Information Technology.
• Established the solutions strategy for unstructured content transfer for all Mergers, Acquisitions, Product Divestitures, Partnership, and Alliances
• Transitioned solutions strategies to project portfolios using gap and business case analysisLed transition of asset-related data of 9 return-to-partner products as a part of the AbbVie R&D portfolio revamp
• Established strategy and led IT programs for divesting 17 products (compounds and medical devices) as it pertains to extracting, transferring and QCing source data related to Intellectual Property, Non-Clinical.
• Managed the IT projects that integrated several acquired companies into the Allergen Aesthetics organization
• Steered the ring-fencing, transfer, and purge of data for numerous divested drug as part of the US Federal Trade Commission (FTC) and EU European Commission (EC) stipulation agreement as part of the approval of AbbVie.

Irvine CA

• Managed several key technology initiatives for moving Allergan R&D into a consolidated future state.
• Veeva Vault Clinical eTMF (Trial Master File) – Led major project including business case justification, program governance, configuration, testing, validation, change management, training, integrations, etc. This was.
• Veeva Vault Clinical SSU (Study Start-Up) - Led intensive project including business case justification, program governance, configuration, testing, validation, change management, training, integrations, etc. This.
• Box GxP Compliance - Led instrumental project including business case justification, R&D governance formalization, validation, migration protocol establishment, permission management workflow engine replacement.
• TriNetX RWD (Real World Data) – Established the use of 75 million electronic patient medical records, including but not limited to: disease state, medications, laboratory results, medical procedures, vital signs.
• TranCelerate – Key member of the Shared Investigator Platform (SIP), eSuite (CPT, SAP, CSR) and Technical Council Teams

Irvine CA

• Directed the implementation and management of Knowledge Management technologies across 46 pharmaceutical, biotechnology and device companies acquired by Allergan within the last five years. Managed the Information.
• Box – Pioneered the uses of Box in the pharmaceutical industry, developed governance process for using Box for R&D partnerships, spearheaded the decision to use Box in place of Microsoft OneDrive, expanding it into the.
• RD Search - Negotiated with technology vendor and both Legal Councils to convert our L-AGN contract to a new Allergan 3-year contact and extend our licenses to 12,000 users which ensured a license cost-free deployment.
• SharePoint – Led the charge to integrate the numerous SharePoint platforms across the acquisition conglomeration of R&D centers, which included evaluating the best of breed and redirecting the Branded R&D organization.

• Managed the Information Management (IM) program across Research & Development, Regulatory Affairs and Medical Affairs which includes the following functions: Enterprise Content Management, Corporate Library Sciences.
• Designed and implemented a fast (Google-like), comprehensive (Kayak-like), and easy-to-use (Amazon-like) search engine for unstructured content internally across all R&D repositories and selected external repositories
• Established an Enterprise Document Management Virtual COE Governance Module for both controlled and uncontrolled content management solutions which consisted of Best Practices, Training, eLearning (learning bursts).
• Developed the Allergan Enterprise Content Management 3-5 Year Strategy and Roadmap and refreshed it every three years
• Operated as System Owner for all controlled and uncontrolled content management systems (including dozens of integrations) across R&D including FirstDoc TMF/R&D (with SPX and CRX), Documentum eSubmissions and eCTDs.
• Researched, selected, procured, and implemented a secure cloud-based device-enabled collaboration solution used to manage project documents throughout R&D 400+ partnership which allowed Allergan to become the ‘partner.

• Built and managed the Information Management program across Research & Development and Regulatory Affairs
• Deployed SharePoint in a way that enabled project and study teams to obtain access and manage relevant specific controlled documents alongside the uncontrolled documents within a single project SharePoint site, which.
• Migrated 154 R&D project teams (transitioned 62 active and retired 92 inactive) and migrated 73 departments from custom Documentum to SharePoint and FirstDocReorganized Corporate Library Service, which reduced the.
• Trained people globally (US, Europe, Asia, Australia/NZ, So. America) on Content Management Best-Practices

• Managed the configuration and implementation of FirstDoc TMF and FirstDoc R&D, including a harmonized permission model, best-practices, training, and support across R&D
• As part of internal project management responsibilities, assumed both the CSC Business Analysis and Project Manager roles, reducing the project costs by over $260K
• Managed numerous FirstDoc system integration projects to ensure data integrity and elimination of labor costs

Advising on business model and finance opportunities to develop and distribute ARV/HIV, hepatitis, and malaria therapeutics to under-developed countries.

Managed the recruitment of the Director of Enterprise Content Management

• Directed the implementation of the first enterprise-wide and largest computer application in Amgen history. Established and managed a Project Management Office (PMO) for the development, deployment and support of.
• Administered an annual program budget of $13.8M from client accounts
• Managed organization of 23 full-time employees and 20-30 contractors/consultants
• Developed Enterprise Content Management strategies and defined Service Roadmaps in concert with Amgen’s strategic plans, which ensured ECM capabilities were deliveredInstituted an Enterprise Services Governance.
• Coordinated the centralization of all DM support, applications, and technologies services, which enabled scalable capabilities to support future company growth
• Using RUP, established and managed program risks, issues, decisions, and workforce management across all projects, which reduced resource and schedule conflicts

Thousand Oaks, California, United States

• Project managed the development and implementation of a new R&D document management system.
• Implemented best practices across the value chain, which enabled the harmonization of EDM processes and eliminated several overlapping systems that resulted in the reduction of support costs and increased process.

• Managed all information systems within Research and Development including budget and staff. Coordinated the stability program for nutritional supplements, foods, beverages and OTC drugs for a multi-billion dollar.
• Managed R&D Information Systems responsible for services, budget and staff
• Implemented enterprise DM system across two divisions and enterprise LIMS system across 13 laboratories resulting in services that support scalable processes
• Supervised department responsible for records management and publishing of Regulatory Dossiers, Manufacturing Instructions, Batch Records, and SOPs
• Conducted regulatory agency inspections ensuring governmental compliance and approval of manufacturing and distribution licenses
• Overhauled stability program for measuring performance of products resulting in shelf life increases and improved product profitability supporting development of 250+ new products contributing to a 440% revenue increase

• Managed numerous departments along the commercialization process within medical device company.
• Responsible for acquiring manufacturing and distribution licenses from the FDA
• Assisted in the development of new medical devices based on market demand
• Managed the software engineering, validation and distribution
• Develop marketing literature and support documentation creating a easier to use product thus reducing technical support costs by 18%
• Lead the outsourcing effort which eliminated two production lines and reduced costs by 35% and 27% delays

• Managed quality control inspectors, laboratory scientists and associated processes.
• Partnered with US Dept of Agriculture Meat/Poultry and Egg/Dairy compliance agencies
• Developed Statistical Process Control program with increase quality by 11% and decrease rework by 17%
• Spearheaded Safety Committee creation and implementation

Executive Masters Of Science Degree, Technology Management

Masters Certification, Project Management

Masters Degree, Business Administration

Bachelor Of Science Degree, Computer Science

Bachelor Of Science Degree, Comprehensive Biology