Blueprint Medicines

  • Cambridge, MA, United States
Blueprint Medicines
Blueprint Medicines Cambridge, MA, USA
How will your role help us transform hope into reality? The Associate Director (MW) is responsible for clinical strategic document expertise across the global regulatory marketed and development portfolio. You will support and guide all clinical regulatory documents to be included in eCTD submissions and other global health authority (HA) submission types, including all original applications, information requests, amendments, responses, and all other clinical submission types. You will supervise regulatory writing vendors to manage submission documents and ensure the science-supported clinical messaging is clear and concise and is fully aligned with program team strategy. You will collaborate with cross functional teams providing timelines and overall medical writing document management activities. You will provide regulatory system and authoring template assessments to further develop and enhance the regulatory writing processes, deliver high-quality submission-ready...