cheryl lange

My current role is a Clinical Document Manager working with clinical documentation in an electronic TMF system for several drug products. Manages documents in eTMF using the DIA TMF Reference Structure and ensures documents are following ALCOA practices and processes accordingly. Tracks Trial Master File (TMF) documents in Veeva, Excel and Access databases. Works with clinical team members and other functional areas on special projects. Assists in reviewing and providing input on SOPs for departmental use. Uses excellent interpersonal skills to interface across diverse functional departments. Leverages strong organizational and time management skills to work effectively within strict deadlines. An analytical and detail-oriented leader with a demonstrated history of delivering consistent, high-quality results.

Actively participates on project teams and provides guidance and input on regulatory issues. Works with cross-functional teams on submission requirements. Obtains and reviews information for submissions to FDA, reviews clinical study documents for quality and accuracy. Establishes effective working relationships with clinical teams and project leaders to resolve documentation deficiencies and issues. Evaluates and proofreads product labels and package inserts for marketed products in accordance with FDA regulations, guidelines and internal SOPs.

Hired at Fujisawa in Feb. 1992 and worked in several departments before moving into the Regulatory Associate position in 1998. Name changed to Astellas in April 2005. Managed FDA submission-related activities, for eight Investigational New Drug Applications (INDs), and annual reports for approximately 40 INDs, 10 NDAs and 10 ANDAs. Key person responsible for the distributor licensing process in the U.S. for manufacturing plants regulated by each state’s licensing agency. Researched, analyzed, and extracted data into final reports for submission purposes. Trained and supervised department interns and contractors. Established and maintained electronic files that could be sourced from any desktop location.