Dr Heike Duerr

Founder, Senior Medical Writer

Lahn Pharma Services GmbH

Dietkircher Weg 9
65549 Limburg/Lahn

+49 (6431) 583445
h.duerr@lahn-ps.com

Profile

PhD in Molocular Neurobiology

Medical writing experience since 5 years

  • CSRs for Phase 1-4 studies, Lay summaries, Investigators Brochures
  • CTD Modules 2.5 and 2.7
  • Writing and/or editing manuscripts for publication, preparing posters and presentations for scientific meetings
  • Entering study results into EudraCT

Pharmacovigilance specialist for 11 years

  • Reviewing drug safety relevant clinical trial documents and providing Pharmacovigilance Input in Clincal Trials
  • MedDRA coding
  • Review of individual case reports
  • Safety signal evaluation
  • Writing Risk Management Plans
  • Writing periodic safety reports such as: DSURs, Annual Safety Reports, assessment reports for bi-annual SUSAR listings, PSURs.
  • Presentation at Investigator’s Meetings
Career History
Lahn Pharma Services GmbH, Limburg a.d. Lahn, Germany
Since 09/2018
Founder, Senior Medical Writer
Mundipharma Research GmbH & Co KG, Limburg, Germany
09/2015 - 09/2018
Senior Medical Writer
Mundipharma Research GmbH & Co KG, Limburg, Germany
08/2013 - 08/2015
Medical Writer
  • Writing and/or editing documents for clinical studies and submission to regulatory agencies:
    - CSRs for Phase 1-4 studies
    - Lay summaries
    - CTD Modules 2.5 and 2.7
    - Investigators’ Brochures
  • Writing and/or editing manuscripts for publication, preparing posters and presentations for scientific meetings
  • Tracking timelines for the creation of these documents
  • Reviewing and editing scientific documents prepared in Medical Research, incl. Clinical Protocols and
  • Statistical Analysis Plans
  • Entering study results into EudraCT
  • Serving as Medical Writing expert on Clinical Sub-teams
  • Training of new employees
Mundipharma Research GmbH & Co KG, Limburg, Germany
01/2011 - 07/2013
Principal Investigational Drug Safety Manager
Mundipharma Research GmbH & Co KG, Limburg, Germany
09/2009 - 12/2010
Senior Investigational Drug Safety Manager
Mundipharma Research GmbH & Co KG, Limburg, Germany
10/2003 - 08/2009
European R&D Investigational Drug Safety Manager
Mundipharma Research GmbH & Co KG, Limburg, Germany
05/2002 - 10/2003
Drug Safety and Pharmacovigilance
  • Setting up Investigational Drug Safety
  • Head of International Investigational Drug Safety working group
  • Advise in safety issues during clinical trials
  • Serving as drug safety expert in Company assigned committees about harmonisation of study reports, assessment of new studies, upper and lower limits of laboratory values, and others
  • Presentation at Investigator’s Meetings
  • Reviewing drug safety relevant clinical trial documents
  • Writing periodic safety reports such as: DSURs, Annual Safety Reports, assessment reports for bi-annual SUSAR listings, PSURs
  • Writing Risk Management Plans
  • Safety signal evaluation
  • Review of individual case reports
  • MedDRA coding
  • SOP writing
  • Training of new employees
Mundipharma Research GmbH & Co KG, Limburg, Germany
05/2000 - 04/2002
Medical Information and Documentation
  • Medical Writing
  • Editing product information (SmPC, patient information sheets, product information in drug compendia)
  • Literature search, review and summary of results
  • Replying to scientific queries
IT
MS-Office
Expert knowledge
Adobe Acrobat
Advanced knowledge
First Doc
Advanced knowledge
Argus Drug Safety Database
Advanced knowledge
SharePoint
Good knowledge
Cognos
Good knowledge
Language
German
Native speaker
English
Cambridge Proficiency Grade A
French
Basic Skills
Latin
Basic Skills
Memberships
EMWA
European Medical Writers Association