Experience

Actelion (now Janssen Pulmonary Hypertension)

• Switzerland
• Pharmaceutical Manufacturing
• 500 - 600 Employee

• Lead, TMF Business Support Analyst

  • Jul 2020 - Present

• Service Manager

  • Apr 2018 - Jun 2020

  System Management● Manage system release process● Manage migration of Actelion’s systems● Contribute to system retirementService Management - Business Analyst● Assess end user needs (business analysis) through close collaboration with business functions, lead requirement elicitation and created requirements documentation● Supervise the 1st level support of all systems managed● Communicate to user community about system outages, releases, bugs, etc.● Quality check tickets of systems managed (incidents, change requests, problems)● Organize UATTechnical writing● Create Knowledge Articles for Agents to guarantee standardized system support by support staff● Author project documentation, such as User Requirement Specifications, Functional Specifications, Configuration Specifications and Test ScriptsQuality Contributor● Ensure systems are in compliance with internal and external regulations and quality system related documentation were created and kept up to date● Review quality documentation, such as Validation Plans, Test Plans, Risk Analyses and ensured the GCP relevant systems were kept in validated status as requested by health authorities● Execute test scriptTraining Contributor● Contribute to develop training documentation and eLearning Modules

• Business Administrator

  • Jan 2018 - Apr 2018

  - Provide support to users as per system related Quality System Documents on below Systems: * ACT.CTP Small: a global tool for secure document exchange and collaboration for clinical study teams which supports a secure study document exchange * ACT.EDC: a single platform providing electronic data capture and clinical data management functionality, based on Rave from Medidata Solutions * ACT.Plan: a project and resource planning and management system for Clinical Development * ACTTrials: Clinical Trial Management System * CD-Snow: a Ticketing Tool for various IT systems and Service Groups within Global Clinical Development * DPP (Digital Pen & Paper): used as a secondary data capture tool for clinical trials at Actelion, where the primary method of data capture used is paper CRFs (case report forms) * eTMF: electronic Trial Master File by Wingspan * GlobalScape: a Secure File Transfer Protocol (sFTP) system used to share and transfer files securely between internal users and external third parties * MedIS: a platform for medical information support for the company and its worldwide affiliates to respond to unsolicited medical information inquiries regarding Actelion products from healthcare professionals * QlikView: a collection of applications based on QlikView and QlikSense. The applications visualize Clinical Development data in dashboards and tabular reports- Collect feedback usage and develop improvement ideas for system improvement and for user training on above systems- Contribute to process support improvements and QS documents authoring- Contribute to specifications for new system releases or project and review Test Plan, Validation Plan, User Requirement Specification, Functional Specification, etc...- Ensure good execution of activities assigned withing the IDORSIA exit plans

• Clinical Development Training Administrator

  • Oct 2014 - Dec 2017

  For the GCD Global eLearning system:- Acted as Business Administrator:o Main point of contact for user queries relating to training records, tasks and examso Allocated e-learning modules to employees in Clinical Development and ensuring completion of allocated moduleso Provided user support as per SOPso Contributed to training material development o Collected and analysed feedback regarding system usage and proposed system improvementso Acted a single point of contact and/or project coordinator for defined activities o Contributed to new system releases or project on behalf of the business userso Liaised with SYSTEM MANAGER as required for a timely resolution of incident/requesto Proof read e-learning modules and provide feedback on functionality and coherence- Acted as System Administrator:o Supported end users to resolve technical issues with e-learning moduleso Operated and administrated the system according all applicable SOPso Managed the system datao Managed the system configurationo Contributed to External Service Provider (ESP) meetings in terms of support, system upgrades and system maintenance as per assignments o Acted a single point of contact and project manager for defined activities o Contributed to requirement gathering and to system improvemento Supported System TestingFor Actelion employees globally:- Acted as Quatro Champion:o Created and managed internal and external training records and courses for employees as per internal SOPso Ensured timely updates and maintenance of records in compliance with internal and external regulationso Acted as Training coordinator: Organisation of face to face training sessionso Tracked attendance and reported information to upper managemento Compiled attendee signature list and organized follow up actions for missing attendeeso Organized, managed and prepared training materials



Notary's Office of Masters Koenig - Beaumlin-Andelfinger

• Altkirch

• Assistant Notary

  • Oct 2012 - Jan 2014

  - Mentoring trainee Notaries - Property law - see task description below - Family law - see task description below - Assisting clients for the signature of preliminaries sales agreement and bills of sale - Meeting organization - Mentoring trainee Notaries - Property law - see task description below - Family law - see task description below - Assisting clients for the signature of preliminaries sales agreement and bills of sale - Meeting organization



Notary's Office of Masters MAYEUX - OESTERLE - SAVIN WATERMAN

• Nancy

• Assistant Notary

  • Jul 2010 - Oct 2012

  Property law Preliminary sales agreements - Established first contact with sellers and buyers to request all the necessary documents - Advised clients on their matrimonial agreement, the need for a will, prenuptial agreement - Reviewed legal documentation - Drafted preliminary sales agreements - Liaised with relevant public administrations after signature of any preliminary sales agreements - Client meeting for signatures Bills of sale - Analysed the legal required documents - Drafted the bill of sale - Taxation of bill of sale - Requested funds from banks for sale transaction - Deed of loan Family law - Provided legal advice to clients, management of divorce records, estate records, estate donation records and prenuptial agreement