Dr. rer. nat. Kirsten Herbach

Kirsten Herbach joined Granzer Regulatory Consulting & Services as Senior Medical Writer in July 2020.

From 2007 to 2020, she worked at Boehringer Ingelheim in different Medical Writer and Team Leader positions. She has written and managed a wide range of clinical regulatory documents, including Clinical Overview, Clinical Summary, Clinical Study Report, Investigator’s Brochure, briefing books, and responses to authority questions.

Kirsten Herbach has substantial experience working in international, multidisciplinary drug development teams. She has in-depth knowledge of of the entire drug development process as well as regulatory requirements and guidelines for clinical documents. She has worked across different therapeutic areas, with a focus on oncology, but also respiratory diseases, diabetes, and cardiovascular diseases.

In her role at Boehringer Ingelheim, Kirsten Herbach also led a small international team of Medical Writers. This included training and mentoring, capacity planning, performance evaluation, and contribution to group development andoutsourcing strategy. In addition, she developed and implemented new approaches for clinical document preparation and company-wide processes.

Kirsten Herbach received a diploma and a PhD in food technology. She holds an advanced certificate from the EMWA Professional Development Programme. She has presented at conferences organized by DIA, EMWA and AMWA.

 

Key knowledge areas:

• Medical Writing