Tracey Henderson's Email Addresses & Phone Numbers

💼 Past Experience

Associate Director, Promotional Integrity, Diabetes at Bristol-Myers Squibb from May 2013 to February 2014 (10 months) in Fort Washington, PA. . Associate Director, Regulatory Affairs Strategy, Early Development at Shire Pharmaceuticals from September 2010 to May 2013 (2 years 9 months) in Wayne, PA. . Associate Director, Regulatory Affairs at Cephalon from January 2009 to September 2010 (1 year 9 months). Neuroscience Group, liaison for clinical development; promotional review - serves as primary FDA contact for assigned projects; reviews documents for regulatory submission, including, but not limited to INDs, NDAs, amendments and supplements, promotional and advertising materials; serves as primary regulatory contact for the Promotional Review Committee providing strategy and guidance for promotional and advertising materials as well as speaker and sales training materials. Senior Manager, Regulatory Affairs at Cephalon from September 2007 to December 2008 (1 year 4 months). Neurology Group, liaison for clinical development; promotional review - serves as primary FDA contact for assigned projects; reviews documents for regulatory submission, including, but not limited to INDs, NDAs, amendments and supplements, promotional and advertising materials; serves as primary regulatory contact for the Promtional Review Committee providing strategy and guidance for promotional and advertising materials as well as speaker and sales training materials. Manager, Regulatory Affairs, Promotional Compliance at Otsuka Pharmaceutical Development & Commercialization, Inc. from November 2005 to September 2007 (1 year 11 months). Promotional Compliance Review, Neuroscience GroupProvided regulatory expertise and support for labeling, advertising and promotional review, and submissions; provided regulatory representation for promotional review teams; provided critical regulatory review and determined whether advertising, sales training materials and product labeling comply with regulations and guidelines. Manager, Regulatory Affairs - Advertising, Promotion, and Labeling at Biogen Idec from March 2004 to November 2005 (1 year 9 months). Advertising, Promotion, and Labeling in Neurology GroupProvided regulatory strategy for communications and labeling enhancement as well as maintenance for US marketed products for the Neurology group; maintained marketed product labeling, including safety updates; interacted with regulatory agencies regarding labeling, advertising and promotion; facilitated the activities related to preparation, revision, and maintenance of the Core Data Sheet (CDS); provided regulatory representation for Neurology Promotional Review Committee; provided Regulatory Training for newly hired sales specialists; created, reviewed, and updated SOPs to support the US labeling process; supported SOP development for the EU labeling process; provided guidance, support, and training for direct report. Labeling Manager; Regulatory Coordinator at Wyeth Pharmaceuticals from January 1999 to March 2004 (5 years 3 months). Labeling Manager - Facilitated the activities related to preparation, maintenance, and revision of CDS, U.S., and Affiliate labeling such as physician and patient inserts for marketed products.Regulatory Coordinator - Coordinated regulatory submissions for U.S. labeling for Women’s Healthcare Products; collaborated with Global Product Development colleagues regarding new applications in Women’s Healthcare Products; coordinated EU regulatory activities related to labeling variations, PSUR submissions, and renewals for Women’s Healthcare products; represented Regulatory Affairs at Global Labeling Team Meetings to ensure consistency with

🎓 Education

In 1997, Tracey Henderson received her Master’sdegree in Microbiology from Thomas Jefferson University Hospitals. Two years later, in 2001, she obtained her Bachelor’s degree in Biology from Temple University. Henderson then worked as a Pharmaceutical Marketing Manager at Saint Joseph’s University from 2002 to 2006. After experiencing success as a manager, Henderson decided to pursue a career in education. Henderson decided to study at Temple University, where she obtained her MBA in Pharmaceutical Marketing in 2006. Henderson is currently a Teaching Assistant in the Microbiology Department at the University of North Carolina at Chapel Hill.

💡 Technical & Interpersonal Skills

Tracey Henderson has a background in neuroscience and advertising, both within the medical industry and beyond. Henderson has worked as a senior manager of regulatory Affairs at Cephalon, a company that makes neurological drugs. She has also worked as a Labeling Manager at Wyeth, where she was responsible for the approval of products worldwide. Henderson is also a Regulatory Writer at Merck & Company, and formerly the Regulatory Coordinator for Labeling at Wyeth. In her spare time, Henderson loves spending time with her family, reading, playing tennis, and spending time with friends.