Reference Projects:

Abbott, Astellas, Bayer, Bavarian Nordic, Lorenz, Medac, Merz Pharmaceuticals, Morphosys, Micromet, NDA Regulatory Service, Sandoz, Stada


Project History:

August 12 to September 13: Select global EDMS and eSubmission system
SME EDMS
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 09 to September 13: 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 12 to July 13:  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 12 to June 12:  Write R&D User Requirements for corporate EDMS
SME EDMS
Mid-size Pharma
- Facilitate user requirements workshops with multiple R&D departments
- Draft User Requirements Specification and provide further input

February 12 to March 12: 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 12 to March 12:  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 11 to November 11: Define Regulatory Informatics Strategy
SME Regulatory Information Management
Mid-size Pharma
- Run workshop Regulatory IT strategy
- Write report
- Write implementation project plan

July 11 to March 12: 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 11 to July 12: 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 10 to January 12: 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 10 to January 12: 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 10 to July 10: 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 11 to October 12: 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 09 to October 10: 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 10 to June 11: 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 09 to March 10: 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 09 to October 09: 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 08 to May 09: 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 08 to August 09: 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 08 to March 10: 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 08 to December 08: 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 08 to August 08: 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 08 to June 08: Interim Head EU Regulatory Operations – Informatics
Top 20 Pharma
SME Regulatory Information Management
- Manage Regulatory Informatics project portfolio

January 08 to May 08: 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 08 to February 08 Support selection of eCTD system
Subject Matter Expert (SME) eSubmissions
CRO
Technologies: eCTD Manager (Extedo)