inVentiv Health 0000102724-Reg. Affairs Assoc. B -5147 in Illinois
The position, under supervision of the manager, makes FDA submissions, reviews requisite/critical documents and reports for completeness and suitability for submission.
? Receive documents from various sources and review for completeness and suitability for submission to FDA.
? Request missing and/or illegible pages, arrange for translations as needed.
? Review regulatory documents to assure FDA requirements are met and are ready for submission. Responsible to handle the release and shipment of investigational drug supplies to the investigators participating in the clinical studies.
? Including assuring the regulations and laws regarding IND submissions and financial disclosure meet compliance.
? Assure CMC and QA have approved the product, and that the labeling of the product meets the regulations for interstate shipment.
? Handle drug re-supplies for the above-mentioned studies.
? Prepare 30-day investigator submissions.
? Gather information and prepare IND and NDA annual reports. With the manager's guidance, prepares new IND, NDA and SNDA submissions, amendments and supplements.
? Work with various functions to resolve any deficiencies.
? Timely review of critical documents for drug release is expected. Independent Judgment Will judge the adequacy of critical documents such as informed consent forms.
? Will judge the adequacy of reports as far as completeness, legibility, need for translation.
Please send resume to email@example.com
Science (biology, chemistry etc.) preferred. (Or Equivalency, special qualifications, certifications, licenses, etc.)
? Work experience: At least 1 year of work experience.
? Understanding of scientific disciplines required. Understanding of FDA regulations governing INDs, NDAs, GCPs, submission processes, submission content, and specific time requirements for various submissions desired.
? Ability to organize and prioritize tasks and work independent of manager. Be able to think of new and better ways to accomplish tasks. Direct temporary help in heavy work situations.
? Work with all team members to accomplish tasks and be able to clearly communicate with the team. Needs to do writing for routine submissions. Think of solutions to overcome problems in making submission goals.
? Review submissions with a critical eye for typos, grammatical errors, pages out of order, etc. Impact of Actions / Decisions -Within functional area:
? This position is expected to review critical documents and handle routine submissions with little input from the manager. With more complex tasks/submissions, work with the manager to accomplish goals/tasks. –
For further details or to apply for this job, please contact:firstname.lastname@example.org
inVentiv Health, Inc. is an Equal Opportunity Employer, M/F/Disabled/Vets that values the strength that diversity brings to the workplace.