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Clinical Research Exposure is needed for this role
Description:
Process all initial regulatory documents for submission to the Pharmaceutical Sponsors and Institutional Review Board (IRB)
Prepare and process all regulatory documentation through the IRB, CTSRMC, FDA and all applicable regulatory review committees
Prepare and process all required regulatory documentation for pharmaceutical companies, contract research organizations (CROs), the NCI and the FDA.
Skills:
irb, regulatory, submission, adverse events
Top Skills Details:
irb, regulatory, submission, adverse events
Additional Skills & Qualifications:
MUST HAVE Experience submitting to the IRB a minumum of 10 times
A Bachelor’s Degree and 2 years to 5 years of experience or equivalent combination of education and experience is required.
1-3 years relevant experience in an academic regulatory environment
IND/IDE/Clinical Trial Application experience
Knowledge and experience with FDA Clinical Trial regulations and guidance’s
Demonstrated ability to work on projects with some independence
Strong writing skills
Review and edit policies
Ability to work in a team environment and independently
Experience Level:
Intermediate Level
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.
Other
$72k-95k (estimate)
03/27/2024
04/12/2024
The job skills required for Regulatory Assistant include Initiative, Clinical Trial, etc. Having related job skills and expertise will give you an advantage when applying to be a Regulatory Assistant. That makes you unique and can impact how much salary you can get paid. Below are job openings related to skills required by Regulatory Assistant. Select any job title you are interested in and start to search job requirements.
The following is the career advancement route for Regulatory Assistant positions, which can be used as a reference in future career path planning. As a Regulatory Assistant, it can be promoted into senior positions as a Regulatory Affairs Specialist III that are expected to handle more key tasks, people in this role will get a higher salary paid than an ordinary Regulatory Assistant. You can explore the career advancement for a Regulatory Assistant below and select your interested title to get hiring information.