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for a specific program. Activities will include program team involvements and presentation skills development. In addition, the fellow will have the opportunity to interact with, and learn from, other
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to each rotation include: Clinical Pharmacology Rotation: • Design and lead clinical pharmacology studies (first-in-human, bioavailability, drug-drug interaction, immunogenicity) • Serve as clinical
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to identify unmet needs and inform comparative effectiveness, global epidemiology to support regulatory interactions and stakeholder disease education & awareness Evidence synthesis with literature reviews and
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promotional materials. Seeks to build and maintain collaborative relationships with all involved in the PRC process and sets a model for professional and productive interactions. • Ensures timely medical
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interactions with regulatory bodies including preparation of meeting requests and briefing documents. Global Labeling Gain in-depth knowledge of labeling regulations regarding Company Core Data Sheet (CCDS), US
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and regulatory strategy. Over two years, the fellow will support submission of industry’s regulatory new drug applications (INDs, CTAs, NDAs/BLAs), labeling, and health authorities' interactions, while
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real-world evidence programs. Gather and synthesize medical insights from healthcare professionals, scientific meetings, literature, and field interactions to inform Medical Affairs priorities and
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cross-functional partners including Patient Services, Commercial Manufacturing, Supply Chain and Brand Marketing teams. Learn the responsibilities of the US Market Access team, including how it interacts
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exposure to external partner interactions, vendor oversight, and opportunities to precept PharmD Co-Op students. Job Duties: · Contribute to the development and maintenance of Ironwood Medical
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management, data sciences, quality and compliance, nonclinical, medical writing and publications, and chemistry, manufacturing, and controls, as well as experience partner interactions and engage in vendor