Medical writing expertise to help biotech and pharmaceutical companies meet their communication objectives.
SERVICES
End-to-end medical writing: from templates to final documents for all phases of development.
Preparing clinical regulatory documents
such as protocols, clinical study reports, investigator’s brochures, pediatric plans, briefing documents, responses to regulatory agency questions, and CTD modules.
Strategy and planning,
including review of documents, review and interpretation of clinical data, key message development, and timelines and resourcing for medical writing deliverables.
Medical writing infrastructure
such as document templates, style guides, workflows, quality control processes, and systems, and medical writing expertise for cross-functional initiatives.
ABOUT KAREN
Karen’s scientific acumen and extensive
experience are strengths that she
brings to document development.
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Karen has more than 20 years of experience in medical writing. She started her medical writing career at a contract research organization (Parexel) and then moved to a biopharmaceutical company (Vertex Pharmaceuticals), where she was hired as their first medical writer. At Vertex, Karen built and led the medical writing department, which grew to include a team of more than 25 people who prepared more than 250 documents per year to support global clinical development programs. In her role of Vice President, Medical Writing, Karen was a member of the senior leadership team in Global Medicines Development and Affairs at Vertex. In 2020, Karen established Eisenhauer Medical Writing Inc. to provide medical writing consulting services to the biotech and pharmaceutical industry.
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Karen has extensive hands-on experience authoring, editing, and reviewing clinical regulatory documents for multiple therapeutic areas from first-in-human through post-approval. She has expertise with a broad range of documents such as protocols, clinical study reports, investigator’s brochures, development plans, breakthrough designation requests, briefing documents, responses to regulatory agency questions, and clinical modules for NDAs/MAAs.
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Karen has demonstrated success in training and mentoring people who transition to medical writing after working in research in academia or industry. In addition, she designed and conducted training in scientific writing for graduate students and postdoctoral fellows at UMass Medical Center and led a course in medical writing at Barnett International.
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Before entering industry, Karen was a postdoctoral fellow at Stanford University Medical Center. She received a PhD in physiology from the University of California at Davis, an MA in biology from Boston University, and a BA in Biology from Mount Holyoke College.
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FUN
FACTS
20+
YEARS IN
MEDICAL WRITING
5+
YEARS ON
SENIOR LEADERSHIP TEAM
5
NDAs/MAAs WITH VERTEX MEDICAL WRITING TEAM
6
PETS:
4 HORSES
2 DOGS
GET IN TOUCH
We look forward to hearing from you.
Karen works collaboratively, partnering with team members to meet the project goals.
Located an hour outside of Boston, MA