Beth Baron Email & Phone Number

Provides contract medical writing and editing services for the preparation of clinical study reports, regulatory submissions, and publications. Projects include preparation of IB updates for compounds in the endocrinology, central nervous system (CNS), and anti-infective therapy areas; INDs for a new chemical entities in the dermatology, cardiovascular, and CNS areas; several pre-IND briefing documents; clinical study reports for Phase 1 and Phase 2 trials in a variety of therapy areas; and publications (manuscripts and poster presentations) in the cardiovascular area. Served as Executive Secretary for data safety monitoring boards for several clinical trials.

Responsible for coordination, preparation, and tracking of regulatory submissions; managed and contributed to IND submission in 3Q01 and tracked subsequent submissions to FDA for three clinical programs. Managed the contracting process for outsourced clinical activities, including requests for proposals, evaluation of bids, selection of vendors, and management of the contracts. Prepared selected SOPs. Served as project manager for two development programs, coordinating meeting agendas, minutes, and resolution of issues.

Designed, implemented, and managed Clinical Development Plan (CDP) process, within specifications provided by the Clinical Executive Committee. Standardized the format for CDPs and incorporated written guidelines into a revised SOP. Established and maintained a review schedule that produced approved CDPs at key time points in development (eg, 3 months prior to IND filing). Initiated systematic distribution of information from CDPs to colleagues worldwide and reconciliation of CDPs with study management and financial databases. Established effective working relationships with review committee members, Clinical Plan Development Team chairs, and database administrators.

Responsibility for preparing research reports, clinical sections of INDs, investigator brochures, NDA/MAA summary documents, and publications at increasing levels of complexity and accountability. Most recently, coordinated NDA document preparation for the Rezulin program, participated in post-submission support of the NDA, and managed colleagues on the Diabetes/Endocrine Team, including those involved in the FemHRT NDA and MAA submissions. Also contributed to NDAs for Cerebyx, Neurontin, and Cognex, and coordinated publications for FemHRT, Rezulin, and Neurontin.

Development proposal writer at University of Michigan Medical Center and Dartmouth College. Medical technologist at several hospitals.

Master Of Science (Ms), Technical And Scientific Communication

Bachelor Of Science (Bs), Medical Technology