Regulatory Publishing Specialist
Location: Richmond, Virginia
Description: TechUSA is presently looking of Regulatory Publishing Specialist right now, this position will be depute in Virginia. Further informations about this position opportunity please read the description below. Frederick, MD
Tech USA is currently seeking a Regulatory Publishing Specialist to join a leading global contract research organization that provides drug discovery, develop! ment, lifecycle management and laboratory services. The Senior Publishing Specialist must have strong working knowledge and experience with publishing and submitting eCTD submissions, using standard industry publishing software. Having a comprehensive knowledge of FDA Title 21 CFR for clinical research, regulatory compliance and quality review of submissions to the FDA, is also a critical need.
RESPONSIBILITIES:
- Lead the assembly of electronic submissions in electronic common technical document (eCTD) format using the company’s available systems.
- Bookmark and hyperlink documents to meet the requirements stipulated in guidelines for incorporation into eCTD submissions using PDF editing tools.
- Ensure documents are submission ready and comply with FDA guidances.
- Ensure quality control (QC) of all documents.
- Maintain all applicable regulatory files, and source documents used to create filings for assigned invest! igational and/or marketed products.
- As applicable, pr! ovides expertise to project teams on the application of paper/electronic submission requirements for specific submissions.
- Support the compilation of paper submissions, as needed.
- Will assist in the tracking of TSG-sponsored products and maintain electronic documents (submissions and FDA correspondence).
- Provide expertise and assist in the preparation of document output that meets requirements for publishing and publishing documents that work with sponsor and/or regulatory agency software programs.
- Shall ensure that all final electronic deliverables meet current regulatory electronic document requirements and guidance.
- Knowledge of and previous application of Common Technical Document (CTD) in paper and electronic formats is required.
(div)(strong)REQUIREMENTS(/strong)(/div)
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(li)Minimum of one year producing electronic regulatory publishing deliverables is(strong) REQUIRED(/strong)(/li)
(li)2+ years of relevant experience using Adobe Acrobat, XHTML, XML and other appropriate markup language where navigation is used OR Advanced degree and 1+ years of relevant experience(/li)
(li)Familiarity with regulatory requirements and guidances for FDA document management and electronic submissions(/li)
(li)Should have experience with electronic CTD (eCTD) publishing software, comprehensive knowledge of FDA Title 21 CFR for clinical research, regulatory compliance and quality review of submissions to the FDA relating to product approval; regulatory affairs guidance and policy document development, regulations and guidelines to ensure FDA clinical research compliance. (/li)
(li)Intermediate to advanced knowledge of Microsoft (MS) Word and MS Excel(/li)
(li)Advanced knowledge of electronic templates (must be particularly skilled in formatting and troubleshooting templates)! (/li)
(li)Ability to manage several complex projects in parallel an! d adapt to rapidly changing priorities(/li)
(li)Ability to independently assess sponsor needs and work with project team members in producing compliant deliverables(/li)
(li)Independently learns new technologies(/li)
(li)Good organizational skills(/li)
(li)Excellent analytical abilities(/li)
(li)Must possess an excellent working knowledge of medical terminology(/li)
(li)Demonstrate excellent problem-solving capabilities and organizational skills and effective interpersonal skills(/li)
(li)Excellent editorial/proofreading skills(/li)
(li)Must be able to create and follow timelines and do long-range planning.(/li)
(li)Must be able to multi task(/li)
(li)Ability to concentrate on the detail in a document without losing sight of the document as a whole and can perform numerous simple and complex tasks without ignoring the overall objectives(/li)
(li)Assist with other regulatory activities as required.(/li)
(li)Experience with elec! tronic CTD (eCTD) publishing software is required. (/li)
(li)Experience with Liquent Insight is a plus but not required. (/li)
(li)The contractor must also be detail-oriented, thorough, and methodical.(/li)
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(div)(strong)About Tech USA: (/strong)(/div)
(div)(em)Tech USA, Scientific Solutions is a comprehensive provider of staffing and workforce solutions throughout the Scientific Industries, including Biotechnology, Pharmaceutical, Clinical Research, Healthcare, Medical Biodefense, Environmental, Chemical and Food Sciences. We are actively seeking candidates for contract, contract-to-hire and permanent placement jobs throughout the nation. View our website to see a list of our current open positions; however, not all of our positions are listed so don’t forget to submit your resume and request a consultation with one of our scientific recruiting specialists to explore your ! opportunities further.(/em)(/div)
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(div)(e! m)At Tech USA we understand that next to your family, your career is one of the most important aspects to a happy and fulfilling life. This is why we take the time to truly understand and get to know our candidates, so we can then pair them with the right job, not just any job. As a result, Tech USA is known throughout the industry for quality, reliability and the highest satisfaction from both our clients as well as the candidates that we represent. TechUSA is an equal opportunity employer.(/em)(/div)
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If you were eligible to this position, please give us your resume, with salary requirements and a resume to TechUSA.
Interested on this position, just click on the Apply button, you will be redirected to the official website
This position will be started on: Thu, 19 Sep 2013 20:51:59 GMT
Apply Regulatory Publishing Specialist Here
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