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.
Freelance Science WriterSint-Gillis-Waas, Belgium
Since January 2014
- 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
- medical translations (English/dutch and vice versa)
- 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
- Medical translations (English/Dutch and vice versa)
Senior Medical Writer Sint-Gillis-Waas, BelgiumJuly 2008 --- January 2014
- preparation, review, edit and qc of clinical regulatory documents, such as, but not limited to:
Clinical Data Reviewer Mechelen, BelgiumFebruary 2005 --- June 2008
- 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
IndependenceOptimismCuriosityAttention to detailWillingness to compromise
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
Skills and Expertise
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
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