MSAT Specialist - 205417

• 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.