Crable Medical Writing

Kathleen P. (Anderson) Crable has a PhD in biochemistry and was an Associate Professor in the Division of Hematology-Oncology at Cincinnati Children’s Hospital before turning to a career in medical writing.

During her 14-year tenure in academic medicine, Dr. Crable wrote and edited grants to federal and private agencies to successfully maintain continuous research funding. In 2005, Dr. Crable took a position as a Senior Medical Writer at Kendle International Inc. (now INC Research), subsequently becoming and Manager of Medical Writing for 2 offices (one in-house, one remote). In 2010, she joined Ledell, Inc., a “boutique” medical writing group in the Chicago area. Dr. Crable is currently a Senior Medical Writer with Randstad Pharma and has established Crable Medical Writing as a means of providing regulatory writing services to her other clients/contacts.

Experience Summary

Extensive experience writing clinical study reports (Phases 1-4), protocols, investigator brochures, narratives, submission documents (including IND components, briefing documents, clinical overviews and integrated summaries of efficacy and safety)

  • Wide range of therapeutic experience including pain, oncology, transplantation and diabetes

  • Effective as a lead writer or in a team setting

  • Reputation for consistently providing on-time delivery of quality documents

  • Reputation for efficient use of time (i.e., quality documents with fewer billed hours)

  • Strong medical science background with research experience contributing to expertise in data interpretation

  • Wrote and edited grants to federal and private agencies to successfully maintain continuous research funding during 14-year tenure in academic medicine

  • Excellent management and organizational skills with demonstrated ability to organize and supervise concurrent work on multiple projects

  • Highly skilled at maintaining engagement with study teams/colleagues while working remotely

  • Extensive knowledge of regulatory requirements

  • Excellent communication skills as a successful medical writing manager and while in academia with numerous presentations at national scientific conferences

  • Excellent writing skills and proficiency in word processing applications and working within document management systems

  • Effective at mentoring other writers