Successfully completed various projects
Recruited by K-Recruiting with excellent feedback and several contract extensions
Clients include biotech, big & medium-sized pharma companies & CROs
Broad range of TA experience: Vaccines, Immunology, Oncology, Cardiovascular, Gastrointestinal, Devices
“Translator” who clarifies and translates complex data into understandable wording
Select your region & language
Our content and services may vary by location.
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Overview
- Availability
- Asap, full-time, onsite & remote
- Qualification
- Registered Toxicologist PhD., Toxicology & Pharmacology
- Language Skills
- Dutch (native), English (business fluent)
- Relevant Expertise
- Medical Writing (Regulatory, Clinical, Scientific, PV), Medical Writing, GCP, Medical Devices, Pharma, Biotech
Key-Facts
Extract from previous activities
Several Companies Pharma/Biotech/Medical Devices
Clinical/regulatory/pharmacovigilance documentation
Development and preparation of documentation for clinical drug development in trial phases 1-3 (including First in Human trials) and pharmacovigilance (phase 4)
Protocols, ICFs, CSRs, IBs, IMPDs, Summaries (Modules 2.4 and 2.5), RMPs, DSUR, PSUR, narratives, bioanalytical reports
Non-clinical documents: reports, analytical plans and reports, validation reports
Two Companies Pharma/Medical Devices
Medical Device Documentation
Development and preparation of documentation for medical device development in trial phases 2-3
Clinical investigational plans, CERs
Systematic literature reviews and primary manuscripts
Several Companies Pharma/Biotech/Medical Devices
Medical Communication
Manuscript preparation and submission to scientific journals
Review of literature
Several Companies Pharma/Biotech/Medical Devices
Nutrition Documentation
Development and preparation of documentation for clinical drug development in trial phase 2-3 o Protocols, CSRs
Preparation of safety documentation including GRASS documents
Writing content material for marketing purposes and review of EFSA health claims Review of literature