Regulatory Affairs Specialist II
Thanks for your interest in the Regulatory Affairs Specialist II position.
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Basic education, experience and skills required for consideration:
- Requires a Bachelors degree in a scientific discipline or equivalent.
- Experience may substitute for minimum education requirements.
- A minimum of 5 to 7 years related experience with a Bachelors or 3 to 6 years with a Masters, or 2 to 5 years with a PhD, and demonstrated working knowledge of scientific principles.
- Up to date familiarity with regulations pertaining to INDs involving CDER, CBER and NIH-OBA activities, including experience as an auditor, quality control coordinator, or compliance officer.
- Computer skills including Microsoft Windows, Word and Excel, Adobe Acrobat.
Preferred education experience and skills:
- Graduate Level Degree in Regulatory Affairs or related field.
- Certification in Regulatory Affairs preferred.
- Must possess excellent written/editorial, interpersonal, verbal communications and computer literacy skills.
- Must communicate technical information in a clear, concise manner.
- Ability to monitor and train other employees.
- Ability to master content across all clinical research areas.
- Previous supervisory experience preferred.
- Preferably has experience with Adobe Framemaker.
City of Hope is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, or status as a qualified individual with disability. #LI-
