RAC, Regulatory Strategist and US Agent – Hecker & Associates, LLC
A biologist/biochemist by training, Sandra Hecker has more than 20 years of experience in drug and biotech development. She was on an Institutional Review Board (IRB) at NIH in the late 1980s, started the Medical Writing (Clinical Submissions) Department at Genentech in 1990, and later worked for several CROs as manager of medical writing/regulatory submissions groups where she collected and developed best, most efficient practices for global safety reporting and regulatory submissions. She later headed regulatory and then drug development groups. Ms. Hecker started her own company in 2001, which advises clients about strategy and requirements for clinical trial applications to FDA and Health Canada, including safety reporting, and represents clients at FDA and advisory committee meetings. She is an US agent for foreign companies filing to FDA. Ms. Hecker’s goal is to create efficient work processes for culturally diverse teams in global drug development, being sensitive to cost constraints typical of small or new drug development companies, and to accommodate ever-changing regional requirements efficiently when working globally.
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