freiberufler Scientific Medical Writer, Clinical Development, Regulatory Affairs auf freelance.de

Scientific Medical Writer, Clinical Development, Regulatory Affairs

zuletzt online vor 5 Tagen
  • auf Anfrage
  • 67063 Ludwigshafen
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  • en  |  de  |  fr
  • 08.04.2021

Kurzvorstellung

17 years of experience, authoring, editing, QC, biostatistics and study design, global teams, regulatory documents (protocol, IB, IMPD/IND, CSR, CTD modules, briefing document, regulatory responses), project management, publication manuscripts

Ich biete

  • Medizinforschung
  • Naturwissenschaft
  • Sozialwissenschaft

Projekt‐ & Berufserfahrung

Medical Writer, Scientific, Regulatory
Arbeitgeber/Kunden: Forschende Pharma-Unternehmen, Diverse
1/2002 – 12/2011 (10 Jahre)
Life Sciences
Tätigkeitszeitraum

1/2002 – 12/2011

Tätigkeitsbeschreibung

2011 - 2011
Chiltern International / Lilly Deutschland GmbH
Scientific Communications Associate
Updated publication plans for German affiliate
Liaised with writers and (other) authors

2011 - 2011
Medpace Medical Consulting
Senior Medical Writer, Regulatory
Wrote IMPDs: nonclinical and clinical module, risk benefit assessment
Quality control of Nonclinical Study Reports and Clinical Study Report (CSR)
Drafted SOPs for pharmaceutical companies

2006 - 2010
Bayer HealthCare AG / Bayer Schering Pharma
Senior Scientific Medical Writer
Responsible for the timely preparation of quality regulatory documents
Coordinated narratives for a regulatory submission (MAA)
Planned, coordinated, drafted and edited CSRs
Coordinated and edited Clinical Study Protocols
Prepared ICH web synopses and FDAAA basic results on time
Prepared clinical sections of CTD (Clinical Summary)
Coordinated external contractors
Managed the timely finalization of relevant documentation
Implemented quality related measures
Contributed substantially to the timely production of critical study reports

2005 - 2006
Sanofi-Aventis Deutschland GmbH
Senior Medical Writer
Responsible for the timely preparation of quality regulatory documents
Coordinated and edited INDs/IMPDs and Investigators Brochures
Drafted, edited and coordinated CSRs
Mentored junior writers
Coordinated external contractors

2002 - 2005
IMEREM GmbH (now: ReSearch Pharmaceutical Services)
Medical Writer
Prepared CSRs for various corporate sponsors
Planned statistical analysis and tables/figures/listings (Statistical Analysis Plan)
Supported and wrote CSRs of an entire clinical development program
Contributed clinical synopses to submission packages
Wrote publication manuscripts for submission to peer-reviewed journals

2002 - 2002
ClinResearch GmbH (now: AptivSolutions)
Medical Writer
Wrote a publication manuscript for submission to peer-reviewed journal
Wrote and edited CSRs

Zertifikate

Advanced Certificate Medical Writing (EMWA)
September 2009
DGPharMed: AM-sicherheit, -zulassung, -information
Juli 2003
Manchester Univ: Academic English
Oktober 1993

Ausbildung

Business Administration
(Master of Business Administration)
Jahr: 2001
Ort: University of South Alabama, Mobile, US
Psychologie
(Dr.phil. Dipl.-Psych. (experimentelle / biologische Psychologie))
Jahr: 1994
Ort: Universität Mannheim, Germany

Qualifikationen

clinical development Phase I to IV and NIS, studies conducted in compliance with GCP, statistical and medical writing, editing, QC, good knowledge of psychometrics, biostatistics and study design, collaborates with national and global teams, prepares and coordinates regulatory documents (Protocol, IB, IMPD/IND, CSR, ICH web-synopsis, FDAAA results reporting, CTD Clinical Summary), manages review and approval, writes abstracts and publication manuscripts

Persönliche Daten

Sprache
  • Englisch (Fließend)
  • Deutsch (Muttersprache)
  • Französisch (Gut)
Reisebereitschaft
auf Anfrage
Arbeitserlaubnis
  • Europäische Union
Home-Office
bevorzugt
Profilaufrufe
1445
Berufserfahrung
26 Jahre und 8 Monate (seit 08/1994)
Projektleitung
5 Jahre

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