2 technical program manager network jobs found

Description Summary: The Technical Writer is responsible for authoring, revising, and maintaining end-user documentation for medical devices in compliance with applicable regulatory and quality system requirements. The ideal candidate has demonstrated experience working within FDA- and ISO-regulated environments and is highly proficient in MadCap Flare for structured, reusable content development. This individual operates with moderate independence and partners cross-functionally to ensure documentation accuracy, regulatory compliance, and consistency across product lines. Key Responsibilities Develop and maintain: o Instructions for Use (IFUs) o User Manuals o Package Inserts o Quick Reference Guides Author content in MadCap Flare, leveraging: o Variables and condition tags o Snippets and content reuse strategies o Multi-channel publishing outputs (primarily PDF) Ensure documentation complies with the applicable labeling requirements Participate in design control...

Job Title: Clinical Database Developer Job Description We are seeking a Clinical Database Developer to support the build, configuration, and maintenance of clinical trial databases in Medidata Rave EDC. This role involves working on complex studies due to the insourcing of databases previously built by Medidata. The transition from the architect module to the designer module in Medidata is underway, making designer training a valuable asset for candidates. Responsibilities Partner with Data Management, cross-functional clinical trial teams, and Clinical Data Standards and Integration to gather and document requirements for Medidata Rave EDC study builds, including CRF design, visit schedules, and data points. Configure Rave studies in Rave Architect, including eCRFs, codelists, subject matrices, edit checks, and derivations, aligning with applicable SOPs and standards. Ensure alignment between Rave study design and data collection standards, including CDASH/CDISC...