Mark Bowlby

Senior Director, Global Submissions at Certara

Role
Senior Director, Global Submissions at Certara
Location
Wayne, PA, US
LinkedIn followers
500 followers

About Mark Bowlby

I am a medical writer working in the pharmaceutical industry for the past 20 years, where I’ve written extensively in the clinical and preclinical drug development areas. My experience encompasses authoring and editing regulatory documents such as IBs, IND (clinical and nonclinical), clinical protocols, CSRs, and briefing documents. I have extensive experience writing manuscripts and review articles, and have been the primary author/editor of 17 published papers in peer-reviewed journals, My therapeutic experience is in the Ophthalmology, Pain, Neurology, and Psychiatry areas, working on projects in late Discovery through Phase 3 trials. I am accustomed to handling, interpreting and organizing data from internal and external sources, summarizing the results in various written and presentation formats.My experience allows me to operate independently, with minimal supervision needed, and generate high quality, organized content on short timelines, while maintaining an attention to detail and consistency. I always meet timelines and adhere to regulatory and company guidelines. I easily adapt to circumstances and can work collaboratively in a team environment or independently with minimal input, depending on the needs of the team. I have sophisticated, critical, thinking skills and an ability to grasp new information quickly.I continue to expand my writing skills, and have completed the AMWA Essential Skills certificate courses and the AMWA Regulatory certificate courses.

Experience

  1. Senior Director, Global Submissions

    Certara

    Jan 2022 — Present

Education

  • UC Santa Barbara

    Ph.D., Neuroscience & Marine Biology

    1985 — 1990

  • Stony Brook University

    Bachelor of Arts (B.A.), Biology/Biological Sciences, General

    1981 — 1985

Skills

  • Clinical Development
  • Neuroscience
  • In Vitro
  • Medical Writing
  • Pharmacology
  • Biomarkers
  • Ion Channels
  • Drug Development
  • Electrophysiology
  • Drug Discovery
  • In Vivo

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Mark Bowlby — Senior Director, Global Submissions at Certara in Wayne, PA, US | Unifers