e-DRA Reference Projects:

Actelion, Abbott, Astellas, Bayer, Bavarian Nordic, J&J / Janssen, Medac, Merz Pharmaceuticals, Morphosys, Micromet, NDA Regulatory Service, Sandoz, Stada


Project History:

2013 - present
various projects in TOP 3 Pharma linkedin


August 2012 to September 2013: Select global EDMS and eSubmission system
TOP 3 Generics
• Advise business and IT during vendor selection
• Facilitate global user requirements workshop for eSubmissions
• Write User Requirements eSubmissions
• Define eSubmission migration requirements
• Analyse processes: EDMS processes, consolidated sequence views, eSubmissions – EDMS interface
• Hold EDMS requirements session
• Provide input to RFP eSubmissions / EDMS
• Participate in vendor sessions
• Support contract negotiations for licenses and services
• Review SOWs
• Define eSubmission / EDMS implementation plan
Technologies: Documentum; eCTD; NeeS


March 2009 to September 2013: Coordinate activities for software vendor: Implement and roll-out global eSubmission System
Project Manager / SME eSubmissions & EDMS
Top 5 Pharma
• Coordinate vendor activities in Europe, US, Canada, Japan for Pharma and Animal Health Division
• Cooperate with internal project manager to organize global roll-out
• Manage major upgrade of system and merge of 5 system instances
• Manage US migration from legacy system
• Hold regular meetings and status calls
• Write Statements of Work / commercial proposals


July 2012 to July 2013:  Separate Global Labeling Systems and migrate
Project Manager / SME EDMS
Top 10 Pharma
• Manage project to separate 3 labeling systems and to implement new processes / SOPs, trainings
• Analyse Labeling processes (document management, affiliate communication, compliance tracking, health authority submissions)
• Define and implement requirements for target EDMS
• Migrate documents from Glemser to FirstDoc system
• Run migration User Acceptance tests
• Relink migrated documents in eCTDXpress Publishing system
• Establish Read-only SharePoint (SPX) environment to give Pharmacovigilance and other departments access to approved labels
• Establish SharePoint environment for affiliate communication
• Manage user training on new system environments
• Manage that implementation of new labeling systems is harmonized with updates to the Quality System
Technologies: Documentum; Labeling System (Glemser); FirstDoc and SPX(CSC); SharePoint; eCTDXPress (CSC)


March 2012 to June 2012:  Write R&D User Requirements for corporate EDMS
Mid-size Pharma
• Facilitate user requirements workshops with multiple R&D departments
• Draft User Requirements Specification and provide further input


February 2012 to March 2012: Write User Requirements for xEVMPD gateway
SME Regulatory Information Management & xEVMPD
Top 20 Pharma
• Discuss user requirements with business users and reporting
• Write User Requirements Specification


January 2012 to March 2012:  Define strategy for migration of Safety Database / vendor selection
Business Analyst / Project Manager
Mid-size Pharma
• Write Hosting Requirements specification
• Market research safety databases
• Write RFI for hosting / ArisG upgrade
• Write board presentation for decision
Technologies: ArisGlobal


September 2011 to November 2011: Define Regulatory Informatics Strategy
SME Regulatory Information Management
Mid-size Pharma
• Run workshop Regulatory IT strategy
• Write report
• Write implementation project plan


July 2011 to March 2012: Select a Regulatory Information Management & xEVMPD System
Mid-size Generics
SME Regulatory Information Management
• Advise on selection of RIM system vendor
• Provide input to selection script
• Review vendor SOW
• Advise on system vendor decision
• Coach project manager during implementation
Technologies: Insight Manager (Liquent); xEVMPD


March 2011 to July 2012: Write EU User Requirements for Global Pharmacovigilance EDMS
SME EDMS / Business Analyst
Top 20 Pharma
• Review European Pharmacovigilance processes and SOPs, inspection findings and EMA PVguidelines
• Interview headquarter PV department and QPPV
• Interview European affiliates
• Document European user requirements for PV EDMS
• Represent EU in global PV EDMS project
• Draft EU implementation project plan
Technologies: Documentum bespoke


November 2010 to January 2012: Analyse eCTD document re-use process / coordinate activities of system vendor
SME eCTD & EDMS / Project Manager
Mid-size Generics
• Run process analysis workshop for eCTD re-use
• Document user requirements for eCTD re-use
• Prepare cost estimation / proposal for eCTD –EDMS import tool
• Coordinate vendor activities
• Coordinate FirstDoc interface implementation
Technologies: docuBridge (Lorenz); FirstDoc (CSC); SharePoint


June 2010 to January 2012: Write User Requirements and select cloud eCTD and EDMS vendor
SME EDMS / Project Manager
Small Biotech
• Hold user workshops to assess requirements for Regulatory and Quality document management
• Write RFI for eCTD vendor
• Write RFI for EDMS vendor
• Hold vendor workshops
• Prepare implementation project plan and budget
• Hold technical workshops for cloud implementation
• Contribute to contract negotiations
• Prepare board presentation
Technologies: eCTDXPress (CSC); Nextdocs


February 2010 to July 2010: Assess if US eTMF system can be implemented in European organisation
Top 20 Pharma
• Review existing US eTMF system
• Hold workshops with EU development departments to review processes for phase II to IV studies
• Document clinical to-be eTMF processes
• Write impact scan report and make implementation proposal
Technologies: Documentum bespoke


May 2011 to October 2012: Implement an EDMS
SME EDMS / Project Manager
Mid-size Biotech
• Implement Regulatory and Quality module
• Prepare implementation CAPA and deviation module
• Manage project plan / costs
• Write validation documentation according to GAMP5 (Validation Plan / Report, Risk Assessment, Traceability Matrix…)
• Execute OQ and PQ scripts
• Coordinate system vendor
Technologies: Nextdocs


April 2009 to October 2010: Write User Requirements and select an Electronic Document Mgt. System
SME EDMS / Project Manager
Mid-size Biotech
• Analyse business processes
• Write User Requirements specification for Regulatory, Quality Document Management System (SOPs) and CAPA and deviation
• Write vendor selection script
• Facilitate vendor selection workshops
• Calculate costs / benefits
• Review vendor SOWs
• Prepare board presentation


March 2010 to June 2011: Implement Global Drug Project Management system
Project Manager / Business Analyst
Top 20 Pharma
• Manage IT project tasks
• Coordinate system vendor and integrator
• Coordinate data center
• Advise project manager
• Provide input to specification and implementation of Planisware – Impact interface
• Write validation documents for CTMS interface
Technologies: Planisware; Impact CTMS


May 2009 to March 2010: Select Global Drug Project Management system
Project Manager
Top 20 Pharma
• Take over project in difficult situation
• Manage selection project successful
• Analyse global project management processes
• Run user requirements workshop with US, Japan, European team
• Write User Requirements Specification
• Define vendor selection scenarios
• Write RFI for system vendor
• Facilitate global F2F vendor selection meeting
• Run system Proof of Concept
• Review vendor SOWs
• Draft implementation project plan
• Write management approval presentations
• Write RFP for system integrator
• Draft system architecture
Technologies: Planisware


April 2009 to October 2009: Coordinate activities for software vendor: Implement and roll-out global eCTD system
Project Manager
Top 10 Pharma
• Take over project in difficult situation
• Specify Documentum interface
• Coordinate activities for software vendor
Technologies: docuBridge (Lorenz); Documentum


July 2008 to May 2009: Support eCTD compilation of DCP dossier
SME eSubmissions
Affiliate Top 20 Pharma
• Support publishing users to create eCTD initial and follow up sequences
• Advise on required structure for EU Module 1 for response to list of questions
• Validate eCTD sequences
Technologies: docuBridge (Lorenz)


November 2008 to August 2009: Implement system and adapt business process to submit eINDs to the FDA
SME eSubmissions
Small Biotech
• Review FDA electronic submission gateway (ESG) / eIND requirements
• Review and adapt business processes
• Set up IT infrastructure for eIND /ESG requirements
• Write eIND SOP
• Run internal eIND training
Technologies: FDA ESG; electronic signature; Adobe Acrobat


March 2008 to March 2010: Manage global implementation of Regulatory Information Mgt. System
Project Manager / SME Regulatory Info Mgt.
Top 20 Pharma
• Plan and manage implementation project
• Facilitate global face to face meetings
• Write global user requirements for EU, US; Japan
• Assess global PSUR tracking requirements
• Write reporting portal user requirements
• Prepare management approvals
• Manage project budget
• Write validation documentation (Validation Plan / Report, Risk Assessment, PQ and OQ scripts...)
• Manage data migration
• Write training strategy
• Coordinate global training
• Coordinate system vendor / data center
Technologies: MISAMM (CPA); Cognos


January 2008 to December 2008: Select GCP Learning Management System (LMS)
Business Analyst / Project Manager
Top 20 Pharma
• Write User Requirements Specification for GCP Learning Management System
• Run user requirements workshops
• Document business processes
• Write vendor selection scripts
• Conduct market research
• Coordinate global project communication
• Coordinate vendors
• Write RFI
• Plan implementation project
• Facilitate corporate LMS user requirements workshop


January 2008 to August 2008: Select, implement and validate eCTD system
SME eSubmissions / Project Manager
Regulatory Service Consultant
• Write User Requirements Specification
• Select eSubmission / eCTD system
• Write Validation documentation according to GAMP (Validation Plan / Report, Risk Analysis, OQ / PQ scripts…)
• Coordinate technical implementation
Technologies: docuBridge (Lorenz)


January 2008 to June 2008: Interim Head EU Regulatory Operations – Informatics
Top 20 Pharma
SME Regulatory Information Management
• Manage Regulatory Informatics project portfolio


January 2008 to May 2008: Manage upgrade of Regulatory Info Mgt. System
SME Regulatory Info Mgt. / Project Manager
Top 20 Pharma
• Manage system upgrade for MRP handling / PSUR tracking and reporting enhancements
• Update User Requirements Specification
• Write PQ scripts
• Manage software vendor and data center
• Document affiliates requirements
Technologies: MISAMM (CPA)


January 2008 to February 2008 Support selection of eCTD system
Subject Matter Expert (SME) eSubmissions
Technologies: eCTD Manager (Extedo)