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Internal Number: REQ-1960
The Gladstone-UCSF Center for Cell and Viral Circuitry, seeks an experienced Medical Writer to author and assemble IND applications for antiviral gene therapeutics.
The ideal candidate will have experience authoring FIH gene therapy antiviral INDs and will be comfortable interfacing with multiple stakeholders at multiple sites (including industry partners, academic scientists, and clinicians across multiple institutions).Â The position will require the candidate to collaborate regulatory activities including manufacturing, toxicology, and clinical aspects across the studies.Â The candidate must be able to work within a fast-paced environment and ideally will contribute to regulatory strategy and execution. This position requires a high degree of confidentiality and is charged with handling and relaying sensitive information and findings.
Tasks include but are not limited to:
Author, assemble, and submit IND applications to FDA
Coordinating preparation of GMP, toxicology, and clinical sections as part of a collaborative multi-institutional projectÂ
Communicating with multiple entities effectively and often to meet project short-term and long-term goals
Coordinating with Gladstone Intellectual Property Department the execution of MTAs, patent filings, sponsored research and service agreements.
Assisting with preparation of study reports and presentationsÂ
Attending regular scientific collaboration meetings to stay abreast of research activities
Assisting PI with regulatory and clinical budgets and subcontract preparationÂ
Coordinating with administrative and research assistants and managers to coordinate operations.
2 years experience authoring IND applications (preferably CBER)
Experience authoring toxicology and/or manufacturing sections of IND (preferably for antivirals)Â
Bachelorâ™s degree (MSc preferred)
Ability to thrive in a fast-paced research environment and highly skilled in multitasking, time management, delegation, and prioritization.
Demonstration of successful IND writing preferred.
Ability to multitask and quickly prioritize work assignments
Ability to communicate effectively with information sources and colleagues in a professional and affable manner.
Commitment to a professional culture that promotes diversity, safety, and environmental consciousness and that is conducive to effective relationships among diverse groups of employees.
Ability to problem-solve and analyze issues without precedent.
Knowledge of a variety of administrative operational activities.
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