Email
Password
Learn more!
Bio
I’m a doctorate – level pharmacologist with more than 20 years of direct pharmaceutical industry experience. Most recently, I was a Senior Scientist with Novartis in their Ophthalmics business unit. Prior, I was the Director of Clinical Research and Regulatory Affairs for Ferndale Laboratories. In April, 2004, Novartis closed its Atlanta location and integrated it with the parent company in New Jersey. I chose to remain in the Atlanta area due to family concerns.

I have extensive experience in the pharmaceutical industry working in large companies (Abbott, Warner-Lambert, Novartis) and small companies (PACO, Ferndale Labs and Tampa Bay Clinical Research), in NDA programs and generics. I’ve highlighted key areas of my career that may be of interest to your company:

• Ph.D. in biochemical pharmacology and drug metabolism (George Washington University), postdoctoral work in pharmacokinetics at UCSF (Les Benet’s department)
• 15+ years of clinical research experience. Have prepared and filed 2 INDs and written HPB and ISS sections of NDAs, plus expert reports, safety updates, many, many protocols and study reports (Phase I-IV and generic drugs), investigator brochures, 483 responses, patient narratives, many manuscripts for publication, 25+ ANDA submissions.
• RAC certified in Regulatory Affairs (1998) – held Director-level Regulatory Affairs position
• 10+ years of experience in drug analysis, assay validation and CRO supervision – both in biological fluids and product composition and stability
• published in the fields of pharmacokinetics, drug metabolism, drug analysis, cardiology, dermatology, and ophthalmology
• extensive experience in a wide variety of therapeutic areas and with most types of formulation including tablets, capsules, transdermal patches, ophthalmic solutions, suppositories, skin creams, nutritional supplements

I have the competency to tackle any project in the clinical or regulatory affairs area, or manuscripts for publication.

Profile Summary:
Medical Writer Cumming, GA
My Skills

Medical Writer

Category: Consulting
Description
15+ years of clinical research experience. Have prepared and filed 2 INDs and written HPB and ISS sections of NDAs, plus expert reports, safety updates, many, many protocols and study reports (Phase I-IV and generic drugs), investigator brochures, 483 responses, patient narratives, many manuscripts for publication, 25+ ANDA submissions.
Relevant Education / Credentials
Ph.D. Pharmacology
Years Experience: 20