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).  The position will require the candidate to collaborate regulatory activities including manufacturing, toxicology, and clinical aspects across the studies.  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 project 

• 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 presentations 

• Attending regular scientific collaboration meetings to stay abreast of research activities

• Assisting PI with regulatory and clinical budgets and subcontract preparation 

• Coordinating with administrative and research assistants and managers to coordinate operations.

Qualifications:

• 2 years experience authoring IND applications (preferably CBER)

• Experience authoring toxicology and/or manufacturing sections of IND (preferably for antivirals) 

• 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.

About Gladstone Institutes

The Gladstone Institutes is an independent, not-for-profit research institution affiliated with the University of California San Francisco (UCSF), transforming the health and well-being of all people through medical research, education, and outreach in the fields focused on heart disease, immunology and virology including HIV/AIDS, and neurological disease. Home to notable leaders in the field of medical science, including 2012 Nobel Prize in Physiology or Medicine recipient Shinya Yamanaka, M.D.,Ph.D. Gladstone is comprised of four institutes in addition to various Centers and programs focusing approximately 500 members of our team on its mission: Science Overcoming Disease. Located in an award-winning building adjacent to UCSF's Mission Bay Campus, Gladstone offers a competitive salary and benefits program within a robust environment for those seeking to maximize their potential. Please consider Gladstone and make a difference in human health.

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