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Summary

we are 3 united scientific writers with more than 10 years of experience in the Pharmaceutical Industry. our writing services span the entire product lifecycle, ie from regulatory writing to Market access-related documents up to medical communications and Medical Education.

our main focuses are quality, Flexibility and a nice personal contact.

Experiences

Current Experience

  • Freelance Science Writer

    Sint-Gillis-Waas, Belgium
    Since January 2014

    responsibilities:

    Responsibilities:

    • Regulatory writing (see job description Senior Medical Writer at Emtex)
    • Pharmacokinetic (PK) support: label updates concerning drug-drug interactions, PK modelling quality control (QC) (in training).
    • Reimbursement dossiers
    • Peer review/Quality control
    • Medical communications and education
    • Editing/Lay-out
    • Medical translations (English/Dutch and vice versa)

Past Experience

  • Senior Medical Writer Sint-Gillis-Waas, Belgium

    July 2008 --- January 2014

    responsibilities:

    • preparation, review, edit and qc of clinical regulatory documents, such as, but not limited to:

    in different Therapeutic Areas (Infectious diseases [hiv, hepatitis, tuberculosis, meningitis, flu], oncology,...) in the field of drugs, Vaccines, immunotherapeutics and Medical Devices.

    • daily Communication with a team of experts
    • Training and support of junior medical writers
    • adherence to regulatory guidelines (ich-gcp), internal and external sops

  • Clinical Data Reviewer Mechelen, Belgium

    February 2005 --- June 2008

    responsibilities:

    • check Clinical database on inconsistent, missing and incorrect data
    • generate queries towards the sites in order to get the data clean
    • communications with all involved parties

Personality

Self Assessment :
IndependenceOptimismCuriosityAttention to detailWillingness to compromise

Knowledge

Self Assessment :
Allergy and immunologyInfectious diseasesMedical oncology Preventative medicineOphthalmologyPediatricsPulmonary diseasesInterpret clinical trial resultsPhases of clinical development (phase I to IV)Understanding of regulatory guidelinesGood Clinical Practice (GCP)Developing Clinical Trial ProtocolsRegistration of the productSearch literature on clinical trialsICH GCP guidelinesInformed Consent DocumentsWriting Study Procedures and SOPsSafety trialsEfficacy trials Scientific writingDrug InteractionHealthcare ReimbursementMarket accessMarketing Authorisation Application (MAA)Medical writingPackagingPharmacodynamicsPharmacokineticspharmacologyQA complianceReport WritingStandard Operating Procedure (SOP)Translational Medicine
LinkedIn Assessment :
regulatory documentsPeer ReviewsEditing

Skills and Expertise

Self Assessment :
Develop clinical trial protocols Interpret data Report data Search literature on clinical trials Write papers Write protocolsAdverse event reportingAttend seminars, courses and meetings within and outside the companyCommunicationConduct literature searchesCreate clinical documentsCreate standard operating procedure (SOP)Create study documentsEnsure consistency between the protocol and CRFEnsure data consistencyEnsure good clinical practice (GCP)Evaluate protocolsInterpret analytical resultsInterpret dataInterpret scientific dataOrganise meetingsPrepare final reportPrepare manuscriptPrepare regulatory documentsPrepare responses to health authority queriesPresent clinical resultsPublication of articlesQuality control processRead medical literatureRegulatory submissionsReport serious adverse events (SAE)Report study conclusionsReview clinical study reportsReview medical reportsReview protocolsSearch literature on clinical trialsSerious Adverse Event (SAE) ReconciliationUnderstand protocolsWork collaboratively with the other members of the clinical research team Work cross-functionallywrite and maintain clinical evaluation reportsWrite final reportsWrite papersWriting regulatory documents

Education

  • High School in Latin-Science from Heilige Familie, Sint-Niklaas in 2017
  • Master in Physical Education and Fysiotherapy from Katholieke Universiteit Leuven in 2004
  • Master in Academic Teacher Eduction from Katholieke Universiteit Leuven in 2004

Training and Certification

  • Pharmacokinetics in drug development - an integrated approach for the non-specialist (London) in 2016 Training
  • Languages

    BrightOwl Assessment:
    Self Assessment:
    Dutch
    Native
    English
    Professional Proficiency
    French
    Elementary Proficiency

Work Preferences

  • Positions I am interested in:
    Medical Writer Medical translator Scientific Writer
  • Work From Home:
    Yes, 4 Days
  • Work Regime:
    BrightOwl freelancer :    25 Hours per week :    75 Free Per Month(in coming months)
  • International:
    No

Area / Region

Sint-Gillis-Waas

Others

Driving License
  • Yes

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