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Smart Impact
- Senior project Manager
Sousse
2013 - maintenant
Smartimpact is a leading consulting, and e-business solution Development Company based in Tunisia (near shore)
Main responsibilities and achievements:
Provide consulting on solutions and technology for life sciences organizations
Software validation (GAMP 5), ITILv3, Portfolio and Project Management.
Leading E-business Dev team (5 persons) to bringing affordable E-business packages( Prestashop/Magento/joomla/Drupal) to small and large business with the latest features at the right scheduled time.
Coordinate all the development process realized by Agile principles, from discover and plan to launch and maintenance.
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Merck Sharp & Dohme
- Manager
Darmstadt
2001 - 2011
Reporting to Associate Director Worldwide Regulatory Operation
Main responsibilities and achievements:
* Integrate various groups at the strategic, tactical and operational levels to unite the strategic executives with the knowledge experts, process experts and operational technical experts into a workable adaptive enterprise program.
* Leading the team that define business requirements, implements and maintains the European Product Lifecycle System application: Regulatory database used to track and manage submissions (CP, MRP, DP, renewal, referral, and variation), it is also used to manage the translation process for PI documents.
* Project leader for all CSA -FIM (Clinical Study Application - First in Man) and EU scientific advice submissions in Europe.
* Providing operational support to the publishing process, coordinate the release of US and international product approval with different functional areas.
* Developing new processes for regulatory operations, including publishing, archiving and e-Submissions (eCTD).
* Managing Outsourcing contracts with CRO and partners, from writing the contract to setting the infrastructures and putting the process flow.
* Implementing project management tools to support the European marketing applications for new franchises.
* Developing and implementing an integrated set of tools to create, collaborate, manage, and access information on a timely basis from a common platform (Portal, Documentum, sharepoint, Web sites, tracking tools).
* PIM: LAT Core Team member (Joint EMEA/EFPIA project to develop a light authoring tool that supports PIM submissions in Europe). ;
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Merck Sharp & Dohm (Europoe),Inc
- Sr Customer Solutions developer
2001 - maintenant
Summary:
• Over 10 years extensive experience in the area of Regulatory operations and IT, from regulatory compliance at a global level, to technology solutions, Business Process Management and implementation of Risk Management programmes in response to shifting needs, both in business and the regulatory landscape.
• Instrumental in implementing a global approach to managing content supporting the Regulatory Affairs business process in Europe.
• Proven ability to consistently deliver results.
• Strong communication and presentation skills.
• Strong understanding business systems and processes, making and supporting decisions
Specialties:
Portal and content management systems design.
knowledge management processes and systems.
Project design and team building.
PMP,ERP,CRM.
Electronic submission and publishing.
eCTD, PIM, LAT, e-Sub,...
Systems development& deployment (Documentum, eRoom,MS sharepoint, Lotus Notes ,Web & XML applications,UML, Regulatory Tracking systems, Aris Global Register , Octagon Viewpoint).
Language: fluent in English, French, Arabic and basic Vietnamese
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Merck & Co
- Senior system Manager
1999 - 2001
(Back office specialist: office Automation team) in the IS EMEA infrastructure department
Reporting to Office Automation Director EMEA
Authentication and deployment project lead
Responsible for managing the MS back office applications (design, implementation, administration, disaster/recovery plan, SLA), including SMS servers, authentication servers and e-mail servers (MS exchange) and Lotus notes servers.
I also provided training courses for the subsidiary IT local support Managers (EMEA) on back office applications.
Authored comprehensive operational procedures (SOP), documentation and recommendations
I was the team leader of the Software Development and Deployment Team.
Main responsibilities and achievements:
* Consolidating a multi-trust domains model in one single domain for Europe (Implementation of MS multiple Master domain model, migrating account from resources domain to the Master account domain using Fastlane Mapping technology, deploying PDC and BDC using unattended installation Wins and Replication Design).
* Member of the Merck Standard PC image Core team: (setting a common PC image and Environment: Developing Lab modelling and accurate test environment, test procedure, validation process, QC and Software packaging).
* Maintaining Desktop configuration consistency through software Inventory and distribution using SMS and WinInstall.
* DAWA (data warehousing) project team member: responsible for setting the infrastructure and the databases.
* EMEA SMS team leader: design planning and implementation of systems management server cross Europe Middle East and Africa region. ;
* Active directory migration team member (design and planning). ;
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MSD
- Sr System associate
1998 - 2001
Authentication and deployment project lead
Responsible for managing the MS back office applications (design, implementation, administration, disaster/recovery plan, SLA), including SMS servers, authentication servers and e-mail servers (MS exchange).
I also provided training courses for the subsidiary IT local support Managers (EMEA) on back office applications.
Authored comprehensive operational procedures (SOP), documentation and recommendations
I was the team leader of the Software Development and Deployment Team.
Main responsibilities and achievements:
• Consolidating a multi-trust domains model in one single domain for Europe (Implementation of MS multiple Master domain model, migrating account from resources domain to the Master account domain using Fastlane Mapping technology, deploying PDC and BDC using unattended installation (53 DC), Wins and Replication Design).
• Member of the Merck Standard PC image Core team: (setting a common PC image and Environment: Developing Lab modelling and accurate test environment, test procedure, validation process, Software packaging).
• Maintaining Desktop configuration consistency through software Inventory and distribution using SMS and WinInstall.
• DAWA (data warehousing) project team member: creating and configuring the NT domain (PDC and BDC’s) installing the MS SQL server 6.5, restore dB’s, creation of test environment, replication and publishing, etc.
• EMEA SMS upgrades (from 1.2 to 2.0): design and planning the upgrade of one central site and 52-child site from SMS1.2 & NT4 to SMS2.0SP2 & W2K.
• Active directory migration team member (design and planning).
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IS EMEA
- System Analyst & NT specialist - Customer support team
1997 - 1999
Reporting to Regional Customer Support Director (EMEA)
Responsible for managing the support of the Clinical Research Information Service infrastructure for EMEA region , including providing the second line technical support for all Merck Research Laboratories subsidiaries in Europe, Middle East, Far East and Africa.
In charge of maintaining and developing standard procedures for the local RIS support teams (installation, configuration and troubleshooting, including problem resolution affecting PCs, connections to AS 400,UNIX, and VAX servers, connections to mail server, RAS, SHIVA and network troubleshooting).
Main responsibilities and achievements:
* Several rollouts of different projects: MS Office, mail, Operation System.
* Developing and maintaining the IS EMEA Research Information Service website.
* Member of the ``Y2K project'' core team, responsible for Merck Research Laboratories applications.
* Designing and implementing connectivity for subsidiaries and partner net (Network and infrastructure). ;
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Merck Sharp & Dohm (Europoe),Inc
- Senior system Manager
1997 - 1998
Reporting to Regional Customer Support Director (EMEA)
Responsible for managing the support of the Clinical Research Information Service infrastructure for EMEA region , including providing the second line technical support for all Merck Research Laboratories subsidiaries in Europe, Middle East, Far East and Africa.
In charge of maintaining and developing standard procedures for the local RIS support teams (installation, configuration and troubleshooting, including problem resolution affecting PCs, connections to AS 400,UNIX, and VAX servers, connections to mail server, RAS, SHIVA and network troubleshooting).
