Medical Writer - (Inds)

Category:Administration
Lab/Area:Weinberger Lab
Description
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

• Assisting with preparation of study reports and presentations
• Communicating with multiple entities effectively and often to meet project short-term and long-term goals
• Assisting PI with regulatory and clinical budgets and subcontract preparation
• Coordinating with Gladstone Intellectual Property Department the execution of MTAs, patent filings, sponsored research and service agreements.
• Author, assemble, and submit IND applications to FDA
• Attending regular scientific collaboration meetings to stay abreast of research activities
• Coordinating preparation of GMP, toxicology, and clinical sections as part of a collaborative multi-institutional project
• Coordinating with administrative and research assistants and managers to coordinate operations.

Qualifications

• Commitment to a professional culture that promotes diversity, safety, and environmental consciousness and that is conducive to effective relationships among diverse groups of employees.
• Experience authoring toxicology and/or manufacturing sections of IND (preferably for antivirals)
• Knowledge of a variety of administrative operational activities.
• Bachelor’s degree (MSc preferred)
• Ability to communicate effectively with information sources and colleagues in a professional and affable manner.
• Ability to thrive in a fast-paced research environment and highly skilled in multitasking, time management, delegation, and prioritization.
• 2 years experience authoring IND applications (preferably CBER)
• Demonstration of successful IND writing preferred.
• Ability to multitask and quickly prioritize work assignments
• Ability to problem-solve and analyze issues without precedent.

Hiring Range
$80K-$120K (DOE)
Additional Information

• Gladstone is an equal opportunity employer.
• Title and salary will be commensurate with education and experience.