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Development of medical content for regulatory document, and responses (including but not limited to NDAs/BLAs, sNDAs/SBLAs, briefing packages and common technical documents Support business development activities, such as due diligence and research collaborations, as assigned by manager. Working as part of a cross-functional team with colleagues representing biostatistics, data management, clinical pharmacology, commercial, regulatory, safety, quality, and project management, or others, as assigned by manager.. The Highest Standards By operating with the highest standards of ethics and integrity, we aspire to live up to the expectations of patients, physicians, and ourselves, and to earn trust in our communities. Diversity We encourage diversity of backgrounds and ideas. We genuinely care for and respect each other, working together as a high-performing team to deliver extraordinary results while embracing different perspectives. Dedication The dedication and passion of our employees enable us to stay focused on what matters most. We push ourselves to achieve the highest level of medical innovation, and to redefine what it means to live with a rare disease. In-Office Hybrid This role has an expectation of working in the office 3 days a week. When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working give us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world. The annual base pay (or hourly rate of compensation) for this position ranges from $280.895,20 to $421.342,80. 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