Meghan Ziegler
Technical Editor, Regulatory Affairs @Harmony Biosciences
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WORK HISTORY
Technical Editor, Regulatory Affairs @Harmony Biosciences
Manages all technical aspects of regulatory documents including, but not limited to, Clinical Study Protocols, Clinical Study Protocol Amendments, Clinical Study Reports, Statistical Analysis Plans, Investigational New Drug (IND) submission documents, IND Annual Reports, New Drug Application documents, and Investigator Brochures • Copyedits assigned documents, applying correct grammar, punctuation, spelling, formatting, and style • Performs data integrity review of assigned documents to ensure accuracy • Reviews documents for content consistency across submission documents • Manages quality control workflow with outside MW and QC vendors • Supports maintenance of document standards, including templates, style guide, drug-specific libraries of standard content, editing checklists, and best practice guides • Supports department leadership in development and maintenance of department SOPs • Assists with management of review schedules across multiple projects • Supports ClinicalTrials.gov postings • Offers solutions and proactive measures to address document quality findings • Manages reference library
EDUCATION
University of Pittsburgh
Bachelor of Arts (B.A.)
SKILLS
ABOUT MEGHAN ZIEGLER
As a Technical Editor at Harmony Biosciences, I manage all technical aspects of…
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