Kerry K. Flory

TAP Pharmaceutical Products (TAP),
Takeda Global Research and Development

Senior Editor

2006-Present

Modified information from clinical study reports into strict format for public posting on clinicaltrials.gov

Edited and quality-checked (QCed) reports in strict deadline-driven environment. (Editing consists of correcting content, punctuation, and grammar for clarity. QCing compound-level and study-level regulatory documents consists of confirming content against International Conference on Harmonisation (ICH-E6), US federal (FDA), industry, and internal company guidelines and regulations.)

• Oversaw and planned editing and compilation assignments for reports (4-5 compounds, ~30 reports at any given time)
• Created, revised, and maintained departmental, interdepartmental, and role-specific training, processes, tools, and checklists related to regulatory document creation and management
• Consulted with other departments to rectify issues with operational procedures
• Assisted in creation, revision, organization, consultation, and dissemination of company’s intranet-based document-management system (ie, ELERIS)
• Mentored new employees/contractors as needed
• Performed all duties of an Assistant Medical Writer (QC and compilation) in addition to the aforementioned tasks

Delta Pharma for TAP

Assistant Medical Writer (Contract)

2005-2006

Edited and quality-checked (QCed) reports in strict deadline-driven environment. (Editing consists of correcting content, punctuation, and grammar for clarity. QCing compound-level and study-level regulatory documents consists of confirming content against International Conference on Harmonisation (ICH-E6), US federal (FDA), industry, and internal company guidelines and regulations.)

• Managed cross-compound calendar for assignment of QC tasks for assistant medical writer roles
• Revised the training program for new employees and contractors; provided new and revised current supplemental training materials

Volt Scientific for Eli Lilly and Company

Scientific Communications Editorial Assistant (Contract)

2003-2004

• Edited clinical trial reports for FDA new drug submissions
• Implemented new processes set forth by my department’s expansion
• Mentored remote location in Singapore on report and publishing SOPs through e-mail and telephone communications
• Learned AMA style and application
• Retained audience (eg, the FDA’s or the subject’s) perspective while working on regulatory documents, subject materials, and forms
• Built interactive training (ie, a mock protocol) to increase awareness and understanding of Phase 1 units and studies