Clinical Regulatory Affairs Associate
Company: Spectraforce Technologies
Location: Cambridge
Posted on: June 25, 2022
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Job Description:
Position Title: Clinical Regulatory Affairs AssociateDuration:06
monthsLocation: Round Lake, 60073 Summary:This position interacts
with multiple departments, as appropriate, involved in regulatory
submissions. The position, under supervision of the manager, makes
FDA submissions, reviews requisite/critical documents and reports
for completeness and suitability for submission.Specific
ResponsibilitiesReceive 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.Must have the
following:Needs to be able 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.Outside functional area: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.About 50% or more of the judgments can/should
is made independently at this position.The rest are made with the
concurrence or advice of the manager.This position might require
the management of temporary labor and supervise the assembly of
submission, and verify that the documents meet the regulatory
requirements.Education Requirement:Science (biology, chemistry
etc.) preferred. (Or Equivalency, special qualifications,
certifications, licenses, etc.)Work experience:Five plus years 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.
Keywords: Spectraforce Technologies, Davenport , Clinical Regulatory Affairs Associate, Healthcare , Cambridge, Iowa
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