Responsibilities

Author, co-author, review, and remediate Drug Delivery Function (DDF) documentation for combination products. Support remediation of post-market documentation and updates to ensure accuracy, completeness, and compliance with applicable quality and regulatory requirements. Develop, revise, and maintain technical documentation related to drug-device combination products, including auto-injectors. Collaborate with cross-functional teams and pharmaceutical industry partners to execute documentation remediation projects. Review existing documentation, identify gaps or inconsistencies, and implement necessary updates. Ensure technical documentation is clear, accurate, traceable, and aligned with applicable procedures and standards. Communicate project progress, documentation issues, and remediation needs to client stakeholders. Manage documentation deliverables and timelines in a fully remote, client-facing environment.

Required Qualifications

Bachelor's or Master's degree in Engineering, Life Sciences, Pharmaceutical Sciences, or a related technical field. A minimum of 2–3 years of relevant experience in technical writing, MSAT, quality, post-market support, or pharmaceutical documentation; 5–6 years of experience is preferred. Required: Direct experience authoring, co-authoring, or remediating Drug Delivery Function (DDF) documentation. Hands-on experience with remediation of technical documentation and post-market updates. Experience with drug-device combination products, particularly auto-injectors. Strong technical writing, documentation review, and organizational skills. Professional communication skills and experience working directly with clients or external stakeholders. Ability to work independently and manage multiple documentation deliverables in a remote environment.