ID EXISTS
POS 4216
Status 11
DJM 1

Regulatory Writer Bioanalytics/Pharmacodynamics

Beschreibung: For one of our Pharma-clients in Baden-Württemberg we are seeking freelance support as: Medical/Technical Writer for Bioanalytics and Pharmacodynamics Dossier (M/W/D)
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Tasks:
  • Convert scientific data into clear, scientifically sound, well-structured scientific, clinical, and regulatory documents intended for global health authorities is essential.
  • Support writing efforts for on Company’s MAA submission packages
  • Collaborate on development of clinical study documents (e.g. clinical study reports, bioanalytical methods reports), in accordance with applicable regulations
  • Liaison with biomarker and immune-monitoring department for bioanalytical technical reports
  • Liaison with CRO medical writer delegates for clinical documents
  • Participate in/lead comment resolution meetings, as applicable
  • Performing a quality control (QC) check of written documents
  • Participate in teams meeting as applicable
  • Complete other responsibilities as assigned and agreed upon
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Qualification:
  • Start: asap, latest 15.01.2021 // Duration: 6 months // Capacity: full-time
  • Minimum of BS/BA degree in science (Masters, PhD, or PharmD preferred) with at least 5 years of relevant regulatory writing experience in the pharmaceutical and biotechnology industry
  • Strong understanding of bioanalytical methods, immune-monitoring, biomarker and pharmacodynamics
  • Strong knowledge and experience with Common Technical Document content templates as well as content expectations for IND/NDA/BLA/MAA and other regulatory documentation
  • Knowledgeable of GCP, GXP requirements and FDA/EMA guidelines
  • Excellent writing and organizational skills, and an ability to generate clear, concise documents
  • Proficiency using Microsoft Word, Excel, and PowerPoint
  • Excellent writing ability with strong editorial and formatting skills
  • Fluency in written and spoken English
  • An independently motivated working style with good problem-solving skills allowing analysis, synthesis, and compilation of data from a broad range of disciplines
  • A demonstrated ability to prioritize tasks, work simultaneously on multiple projects, and complete high-quality documents according to timelines
  • An ability to work in a fast-paced, cohesive, collaborative team-oriented work environment
  • Certification in medical writing and/or Medical Writer Certified preferred
  • Nice to have: German
Bemerkungen: WANTED: Regulatory Writer Bioanalytics/Pharmacodynamics (M/F/D). Please contact +49 89 18 90 99 813 oder johannes.schwarz@k-recruiting.com Skills: EMA (European Medicines Agency), English, FDA (USA: Food and Drug Administration), GCP (Good Clinical Practice), German
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Interesse geweckt?
Auf geht's!
Beginn: asap, latest 15.01.2021
Laufzeit: 6 months
Einsatzort: Baden-Württemberg
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