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Summary

**available for new opportunities. contact me on +44 (0)118 328 0173 or sandravignes@yahoo.co.uk **  registered Pharmacist with a broad knowledge, from direct experience, of the medical and quality functions of pharma, particularly Regulatory Affairs, also of Data Management, medical information, Pharmacovigilance and Clinical research.  learning and instructional design skills in elearning, blended and informal learning, virtual Training, learning management, and face-to-face Training delivery. a proven record as the instructional design intermediary between the pharma business and elearning developers, also fluent in tools such as adobe captivate and litmos.  success in leading globally-dispersed, virtual, cross-functional teams.  delivery of f2f Training on 6 continents.  Communication of complex and/or technical information at audience-appropriate level: to physicians, patients, Pharmaceutical executives, government officials, colleagues, and learners from around the world.  cultural awareness, gained from several years of global business travel, particularly in asia-pacific, and from my own experience of intercontinental relocation for a multinational company. keywords: performance Consulting; adobe captivate; EMA; mhra; tga; FDA; litmos; E-Learning; adult learning theory; scorm; Training needs Analysis; tna; Compliance; addie; saes, ecis, Pharmacovigilance; psur; Regulatory Affairs; mentoring, cultural awareness; labelling, Communication; process improvement; lean; simplicity; articulate; SharePoint; CTMS; Pharmacy; commercial acumen, different Therapeutic Areas; blended learning; Training; manuals; Clinical Development; offshore vendors; Formulation; bioequivalence; generics; GMP; qc; medicinal products; drug; Vaccines; virtual teams; Medical Devices; webinars; Instructor-led Training; global projects; early phase; virtual environments; Microsoft Office; regulatory submissions; Pharmaceutical products, getting things done

Experiences

Past Experience

  • Learning Solutions Manager

    November 2013 --- November 2014
    senior Member of european satellite of hq learning and development department, merck polytechnic institute (mpi), serving merck Research laboratories (mrl) globally. support and Analysis of the Training needs of client groups across asia pacific, emea, and the americas (including usa). recommendation of learning solutions with sound instructional design which address identified performance gaps. oversight of in-house or offshore development of elearning. management of these projects to be high quality, on time, effective and enjoyable, maximising roi.

  • Senior Specialist, Learning and Development

    August 2012 --- November 2013
    focus was on Regulatory Affairs, however supported needs across the Research division. global delivery of Training: face-to-face, virtual and elearning. expansion of skill set to more technical aspects of elearning. instructional design and management of projects developed by offshore vendors. elearning cbt wbt developer for company-wide Applications. fluent in adobe captivate and litmos by callidus cloud.. developed and delivered face to face, virtual and asynchronous web-based Training in Clinical trials management systems (CTMS). coordination of globally-dispersed teams to bring projects to fruition.

  • Training Facilitator

    November 2008 --- July 2012

  • Learning Technology and Training Specialist

    October 2006 --- November 2008

  • Project Trainer - New Technology

    December 2003 --- October 2006

  • Associate Project Trainer - New Technology

    January 2003 --- November 2003

  • Associate Data Management Coordinator- User Trainer

    January 2001 --- December 2002
    initially based in sydney, australia and responsible for Clinical systems Training across the asia-pacific region. extensive global travel over a 7-year period (see changes in title over this time) enhanced cultural awareness. relocation from australia to europe and promotion within this function. travel throughout europe, asia pacific, south africa and the americas.

  • Regulatory Affairs Associate

    November 1997 --- December 2000
    was responsible for various regulatory submissions, including key Marketing Applications, with accelerated review status, and Clinical Trial authorizations, to the therapeutic goods administration in australia. Member (responsible for input on regulatory strategies) of various cross-functional teams charged with bringing products to market, active interface with all facets of the business: Marketing, Health Economics, clinical, public affairs, Manufacturing. specialties in hiv therapy, Osteoporosis and ophthalmics. 6 month assignment as a Clinical Research Associate (CRA).

  • Regulatory Affairs and Medical Information Associate

    January 1996 --- November 1997
    prepared first canda (computer-aided New Drug Application) application for the australian subsidiary during brief assignment at hq in berlin. re-scheduling of azelaic acid (skinoren) from prescription to otc medical information: direct interaction with Healthcare professionals and the general public, answering queries regarding the company's products. administered special access scheme (beta interferon for relapsing-remitting multiple sclerosis) new Marketing and variation Applications to the therapeutic goods administration.

  • Registered Pharmacist

    November 1993 --- January 1996
    dispensing of medication and patient counselling, including daily interaction with prescribing physicians dispensary and front-of shop stock control extemporaneous compounding of medications

Knowledge

LinkedIn Assessment :
Cross-functional team leadershipCTMSClinical trialsRegulatory affairsPharmaceutical IndustryClinical researchTrainingGCPSOPClinical DevelopmentE-LearningRegulatory RequirementsProcess improvementQuality Assurance (QA)Regulatory submissionsClinical pharmacologyICH-GCPCommunicationVendor ManagementIntercultural CommunicationClinicalGlobal TeamsCultural AwarenessLean ThinkingAsia PacificAnalysisTraining DeliveryChange ManagementComplianceEnglishCaptivateSME managementProblem SolvingDrug DevelopmentBlended LearningpharmacologyCorporate RelocationClinical monitoringGMPEDCClinical trial managementMedical affairsAdult EducationTravelBusiness TravelPharmacyCross Functional Team BuildingADMESoftware DocumentationE-learning Implementation

Education

  • in Dutch Language Course from CVO Tervuren in 2014
  • PostGrad Dip in Drug Development from University of New South Wales in 2000
  • Bachelor of Pharmacy (B.Pharm.) in Pharmacy from University of Sydney in 1993
  • New South Wales Higher School Certificate in Physics, Chemistry, Higher Economics, English, Higher Mathematics from Macksville High School in 1990

Training and Certification

  • Captivate 8 Essential Training in 0000 Certification
  • Google Classroom: First Look in 0000 Certification
  • Lean Six Sigma Yellow Belt in 0000 Certification
  • Registered Pharmacist in 0000 Certification
  • The Science of Sales in 0000 Certification

Area / Region

London, United Kingdom

Others

Driving License
  • Yes

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