Summary
Overview
Work History
Education
Skills
References
Languages
Timeline
Generic

Anne-Marie Thonning Skou

Summary

As a candidate for the Regulatory Writer position, my curiosity, fast learning abilities, and strong motivation drive me to seek new challenges. Eager to fully invest myself and grow with Novo Nordisk, I thrive on finding trends and errors in data and documents. With a keen eye for detail and a passion for creating structure out of chaos, I excel in developing SOPs, protocols, regulatory dossiers, technical documentation, literature searching, data management and analysis, and process mapping. Efficiency and optimization are my guiding principles in both text and processes, allowing me to save valuable time for the team and the company. Leveraging English as my native language throughout my career has enabled me to excel in crafting articles and dossiers, networking with European colleagues and regulatory authorities, and facilitating workshops at the European level.

Overview

21
21
years of professional experience

Work History

Technical Writer

GE Healthcare
Herlev, Denmark
08.2024 - Current
  • Performed quality control of over 400 product documents in 20 different languages
  • Project manager for CAPAs in the team
  • Aligned document release process and prepared streamlined documentation
  • Structured and optimized internal processes
  • Completed all necessary regulatory training, including: ISO 13485, risk management, root cause investigation, CAPA, QMS, GdocP
  • Certificate in Design Control for Medical devices
  • Scribe for DNV MDSAP audit
  • Change advocate during integration
  • Managed version control and timely updates of documents through effective project tracking and organization skills.
  • Implemented feedback from end-users to continuously improve the quality and effectiveness of documentation materials.
  • Coordinated with subject matter experts to ensure the accuracy of technical content in documentation projects.
  • Conducted thorough document reviews to identify inaccuracies, inconsistencies, or areas needing clarification.
  • Enhanced user experience by simplifying complex technical concepts into easy-to-understand documentation.

EMEA Lead Dossier Writer

Bayer A/S
Copenhagen, Denmark
09.2022 - 08.2024
  • Project coordinator for submission strategy across multiple projects simultaneously, liaising with EMEA colleagues in Regulatory, Project Management, and Marketing
  • Led and provided overview and guidance to other writers in submission strategy and data analysis per project
  • Managed competing deadlines with efficiency.

EMEA Data Manager and Dossier Writer

Bayer A/S
Copenhagen, Denmark
04.2016 - 08.2024
  • Managed and wrote over 40 regulatory product and active substance dossiers and technical documents for authorities across EMEA, according to GAP
  • Presented strategy and data package in pre-submission regulatory meetings
  • Streamlined data management workflows for increased efficiency and reduced processing time.
  • Searched literature from multiple locations, including peer-reviewed articles
  • Managed and analyzed complex data sets
  • Key user for our internal database of trial data, focusing on increasing quality
  • Change advocate during organizational restructuring
  • EMEA Editor of Field Solutions Newsletter
  • EMEA Co-lead for Diversity, Equity, and Inclusion initiatives


Innovation Consultant

AgroTech
Taastrup, Denmark
01.2012 - 03.2016
  • Managed, researched, executed, documented, and analyzed various biotech and plant pathology experiments
  • Analyzed data from various greenhouse and lab experiments
  • Created SOPs
  • Delivered high-quality presentations to stakeholders, effectively communicating project objectives and results.
  • Evaluated customer needs and feedback to drive product and service improvements.
  • Designed tailored training programs for employees at various levels within the organization, boosting overall skillsets.
  • Generated reports detailing findings and recommendations.
  • Co-authored a peer-reviewed article

Scientific Proofreader/Translator

Freelance
Copenhagen, Denmark
01.2004 - 01.2016
  • Proofread and edited Master theses, Doctoral dissertations, manuscripts to be submitted to refereed journals, and popular scientific articles
  • Translated and edited articles from Danish to English
  • Managed finished works and version edits for comprehensive record of each file.
  • Checked and corrected grammatical and spelling errors in diverse documents.

Education

Ph.D. - Plant Ecology

University of Copenhagen
Copenhagen, Denmark
10-2011

Master of Science - Horticulture

Virginia Tech
Blacksburg, Virginia
05.2002

Bachelor of Science - Biology

James Madison University
Harrisonburg, Virginia
05.1998

Skills

  • Project management
  • Technical Writing/Editing/Proofreading

  • Data management and analysis
  • Literature/information searching
  • Microsoft 365
  • Adobe Creative Cloud
  • Dashboards
  • Change Advocate
  • Document formatting
  • Agile methodology

References

Louise Lading, former manager at Bayer

Louise.lading@bayer.com

+45 2916 4205


Signe Værbak, former manager at AgroTech

signe.vaerbak@gmail.com

+45 2044 0176

Languages

English
Native language
Danish
Proficient
C2
French
Intermediate
B1

Timeline

Technical Writer

GE Healthcare
08.2024 - Current

EMEA Lead Dossier Writer

Bayer A/S
09.2022 - 08.2024

EMEA Data Manager and Dossier Writer

Bayer A/S
04.2016 - 08.2024

Innovation Consultant

AgroTech
01.2012 - 03.2016

Scientific Proofreader/Translator

Freelance
01.2004 - 01.2016

Ph.D. - Plant Ecology

University of Copenhagen

Master of Science - Horticulture

Virginia Tech

Bachelor of Science - Biology

James Madison University
Anne-Marie Thonning Skou