Medical Writer - (INDs)
- Gladstone Institutes
- San Francisco, CA
- Start date
- Mar 27, 2023
- Clinical, Clinical Documentation, Medical Writing
- Required Education
- Bachelors Degree
- Position Type
- Full time
- Biotech Bay
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.
2 years experience authoring IND applications (preferably CBER)
Experience authoring toxicology and/or manufacturing sections of IND (preferably for antivirals)
Bachelor’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.
- Title and salary will be commensurate with education and experience.
- Gladstone is an equal opportunity employer.
Gladstone is an independent, nonprofit life science research organization located in the epicenter of biomedical and technological innovation in the San Francisco Bay Area. Gladstone has created a research model that disrupts how science is done, funds big ideas, and attracts the brightest minds. Gladstone Institutes leads the way for innovative research in the biomedical field. We always seek dedicated and talented individuals to join our team.
Scientists know that using a diversity of approaches is often the most efficient strategy for solving a problem. New and different perspectives engender the very innovation that Gladstone prizes. This is one of the many reasons why we value diversity at Gladstone—be that a diversity of race, culture, religion, mental or physical ability, heritage, age, gender, sexual orientation or other characteristics. Our employees hail from more than 30 countries around the globe and we seek to hire the best and brightest for our diverse team of scientists and administrators. Career opportunities are available in both our administrative offices and our research areas.
Gladstone offers eligible employees—and their dependents—a comprehensive range of benefits, including health insurance, retirement savings, and professional development.
- Health and Retirement
- A choice of medical plans, flexible spending account, and retirement account options that include employer contributions help you take care of your health and your future.
- Time Away from Work
- More than just vacation days, our paid and unpaid leave policies offer flexibility to help you confront different stages of life including maternity and paternity leave, as well as other types of family leave.
- Professional Development
- Gladstone encourages employees to seek the skills they need to remain at the forefront of their profession. By supporting professional development workshops and continuing education, Gladstone provides employees with the resources they need to evolve in their role and in their career.
- Gladstone Cares
- A specially selected suite of benefits to support you in and out of the workplace. Includes resources for dealing with the many stages of life to specific coverage for family planning, and back-up child or elder care coverage.
1650 Owens Street
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