Support the Workstream (WS) Leaders by drafting future-state procedural documentation based on the outputs from the applicable ECMP phases, events and regulatory requirements.
Gather and review site-level procedural documentation.
Support in-person ECMP and WS-centric events.
Complete any necessary ECMP forms to capture outputs and outcomes for applicable ECMP phases and meetings.
Review and verify accuracy and completeness of documents.
Coordinate and route ECMP related and ECMP WS Output documentation for approval.
Other duties as assigned.

Bachelor's degree is required.
8+ years of experience in technical writing is required, or equivalent.
Experience in medical device, pharmaceutical and / or biotechnology industries is required.
Experience in working within compliance frameworks such as FDA, ISO 13485, and EU MDR is required.
Advanced technical writing, presentation, bibliographic research and editorial skills are required.
Strong ability to interpret and disseminate relevant product information is required.
Strong organizational skills, attention to detail and proofreading skills are required.
Demonstrated project management skills are required.
The ability to produce procedures, reports and documents independently and evaluate the writing of others is required.
The ability to rapidly develop expertise in the company's internal document management system is required.
Experience with Electronic Documentation Management Systems and Electronic Approval Systems is required.
Being comfortable leading teams and educating team members as needed during process of document development is required.
Ability to travel up to 40% if needed based on ECMP Workstream needs.

Technical Writer, Quality Compliance

Key skills