- Versatile technical writer/editor with extensive experience over multiple industries.
- Delivers documents that consistently meet expectations for the target audience, from concert program notes and aircraft engine procedures to codifications of municipal legislation and summaries of judicial opinions, in accordance with the relevant style guides, plus firm correspondence and bids.
- Strong editorial acumen in identifying details of technical interest for both clients and team members; adaptable under fluid priorities to maintain independent and timely production to high quality standards; consistent attention to detail as well as overview over entire span of project.
- Product Labels
- Validation Guides
- White Papers
- Desktop Publishing
- ISO Standards
- FDA 21 CFR Part 820
- ISO 13485
- Frame maker
- QS - 9000
- OFFICE (expert)
- Adobe Creative Cloud
- Label View
- MS Teams
- Participating in rationalization and consolidation of lists of IT SOPs resulting in the development of the Master IT SOP list.
- Creating, editing, and reviewing SOP documentation involved in operations, software and hardware procedures.
- Assisting in the SOP development lifecycle as required by FDA and EU regulations.
- Working closely with Subject Matter Experts (SME) to document technical procedures.
- Educating team on best practices for SOP development.
- Providing subject matter expertise, documentation, and recommendations as needed for new or existing team members to align on best practices for documentation management.
- Tracking project deliverables, schedules and team assignments across all projects within the group
Senior Technical Writer
- Advise, write or revise in support of subject matter experts (SMEs), authors and process owners in defining and producing lean Quality System documents and records; and, ensure over 300+ tier 1-3 processes comply with FDA, ISO, and internal standards.
- Perform gap analysis on existing medical device, software validation (SW), process and/or training documentation and ensure documents are consistent, current and accurate.
- Consult CAPA teams and perform gap analysis in role-based training, cGMP/GDP compliance and document control.
Confidential - East Norriton, PA
Senior Technical Writer
- Working closely with cross - functional teams, I develop, edit and update a variety of technical documentation to support multiple applications in the Confidential eHealth software product line.
- Each Confidential product is unique and so are the product users. I translate technical jargon into easy to understand information with step-by-step instructions that allow users at all levels of an organization to access and use the features and functions in our products.
- Working closely with the product manager and cross-functional team members, I coordinate and perform the activities that occur for each project. High level activities include:
- Analyze project requirements to determine appropriate documentation needs.
- Review existing materials for product or use template and style sheets I developed for new products.
- Develop plans and timelines for activities, to ensure that deliverables are produced and released as required.
- Attend and run meetings with cross-functional team members.
- Coordinate with appropriate individuals or teams (UX/UI, Development, Validations) to get access to the systems and information about enhancements to features and functions.
- Identify Subject Matter Expert (SME) reviewers and work with their schedules to get input on draft versions and resolution of issues to ensure that deliverables are high quality and provide maximum value to users.
- Additionally, I developed a style guide and template for the technical documentation that is produced by the company. These materials are used by people inside and outside of the organization to create and update a variety of customer-facing and regulatory-required documentation.