Skilled regulatory medical writer with over 12 years of experience in the regulatory writing business rendering professional services to both big and small pharmaceutical companies across a number of therapeutic areas.

Authored, reviewed and managed high quality regulatory documents for submission to US, EU and other regulatory agencies. Interfaced with contributing groups (Toxicology, Clinical and Nonclinical Pharmacology, Statistics, Data Management, Chemistry and Formulations, Pharmacovigilance, Regulatory, Health Outcomes and Publishing).

Authored and updated various clinical trial-related documents such as protocols, protocol amendments, investigator's brochures and clinical study reports. Mentored and provided guidance to junior writers.