Laura T.
Medical Writing Operations Specialist at Vertex Pharmaceuticals
- Role
- Medical Writing Operations Specialist at Vertex Pharmaceuticals
- Location
- Plainfield, IN, US
- LinkedIn followers
- 500 followers
About Laura T.
Accomplished medical editor with over 25 years pharmaceutical experience with a Fortune 500 company, primarily focused on Regulatory Submission and Clinical Trial Registration documents, as well, limited experience with global product labeling. Proven success working across multiple cross-functional therapeutic areas. Strengths include resourceful project management, meticulous eye for detail, precise timeline management, well organized, reliable prioritization, flexible multitasker, excel under pressure. Proficiency with Microsoft Office, Adobe (Acrobat, Distiller, Professional), Windows Explorer, Documentum, Skype for Business 2016.
Experience
Medical Writing Operations Specialist
Apr 2019 — Present · Indianapolis, IN, US
QC review of regulatory and clinical study documents, including clinical study reports and protocols- Uses the electronic data management system (eDMS) to track, route, file, maintain, and archive Medical Writing (MW) documentation, including clinical study report appendices- Performs high level information searches in the eDMS and various Vertex document repositories; reviews, analyzes, and recommends or takes action based on gathered data- Ensures compliance with department, company, and industry regulatory requirements- Provides troubleshooting and training to all levels on key MW processes and systems- Communicates ideas for new processes and/or business operations for process improvement- Leads implementation efforts to change internal procedures and processes as assigned- Regularly interacts with a variety of employees internally- Represents MW department on assigned projects and/or task teams- Prepares presentations for cross-functional audiences- Participate in the development and implementation of MW strategy for specific business processes and MW initiatives, including work on SOPs, work instructions, templates, and checklists- Support MW on programs and cross-functional initiatives- Performs other duties as assigned, which may include writing shell CSRs, CSR narratives, creating in-text tables, and preparing slides for meetings
Education
Concordia University-Wisconsin
Bachelor’s Degree, Health Care Administration
2000 — 2003
Ivy Tech Community College
Tech Certificate, Medical Secretarial
1991 — 1992
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