Patricia White
Nonclinical/Scientific/Regulatory Drug Development Expert and Medical Writer
- Role
- Independent Consultant at Multiple Companies
- Location
- Boston, MA, US
- LinkedIn followers
- 500 followers
About Patricia White
Experience in nonclinical pharmacology, ADME, and toxicology research, including 15+…
Experience
Independent Consultant
Jul 2017 — Present · Boston, MA, US
Independent Service Provider for nonclinical study conduct, writing, and writing support in pharmaceutical or scientific communities. Experienced writer with NDAs/MAAs, INDs, IMPDs, IBs, DSURs, specialized regulatory documents (CAC and SPAs), briefing documents, responses to agencies, and can specialize in nonclinical research/pharmacology, DMPK, and toxicology reports. Flexibility with assuming lead writing responsibility including scientific interpretation, risk/benefit analysis, or can assist scientists based on needs. I can work in highly regulated GLP environment and am familiar with regulatory guidance from most large agencies and ICH. I also have experience setting up writing and publishing processes, am familiar with document repositories, templates, and style guides. I am well- versed in Word and Adobe. In my last position, I built a writing group for a small pharmaceutical company with great enthusiasm.
Education
Northeastern University
Doctor of Philosophy - PhD, Neurobiology and Neurosciences
Northeastern University
Master of Science (MS), Pharmacology
2001 — 2003
Northeastern University
Doctor of Philosophy (PhD), Pharmacology, Neuroscience
2003 — 2007
Western Michigan University
Bachelor of Science (BS), Biomedical Sciences, General
1993 — 1998
Western Michigan University
Bachelor of Science - BS, Biochemistry
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