Ben Berkey

About Ben Berkey

I am a driven pharmaceutical professional with more than 10 years\' experience as a supervisor, project manager, editor, writer, and quality reviewer for journals, commercial publications, regulatory submission documents, lay language summaries, websites, and magazines. My passions include staff recruitment and development, clinical research, medical and technical writing, and looking at ways to innovate and enhance processes and teams. Editorial Styles: APA, AMA, regulatory submission requirements, and electronic common technical document (eCTD) compliance. Technical Proficiencies: Microsoft Office Suite, Adobe InDesign, Adobe Photoshop

Experience

1. Senior Manager, Quality Control

   Inseption Group

   Dec 2022 — Present · Philadelphia, PA, US

   Formulate and manage the QC strategy for documents and regulatory submissions, including QC and editing assignments, timelines, and resource requirements - Ensure that resources (eg, headcount, funding, time) are appropriately represented to relevant teams and management - Ensure consistency and efficiency across all deliverables within the QC process - Develop and maintain processes to support the execution of regulatory documents from draft through approval - Collaborate with authors and/or study teams to manage QC timelines, which is dependent on the complexity, length, and level of QC required for the document, and determine the intended delivery date - Delegate tasks to the QC staff, as appropriate - Manage QC employees and contractors, as appropriate - Formulate and execute internal training - Maintain document files within the electronic management system for the purpose of version control, compliance, and security

Education

• University of Pittsburgh-Johnstown

  Bachelor of Science (BS), Psychology with a concentration in Creative Writing, Magna cum laude

  2003 — 2007