Regulatory Affairs Specialist V (5608050)

Company DescriptionArtech is the 10th Largest IT Staffing Company in the US, according to Staffing Industry Analysts' 2012 annual report. Artech provides technical expertise to fill gaps in clients' immediate skill-sets availability, deliver emerging technology skill-sets, refresh existing skill base, allow for flexibility in project planning and execution phases, and provide budgeting/financial flexibility by offering contingent labor as a variable cost.Job DescriptionJob Description:Candidate to author technical documents in Client's internal documentum system. Must have working knowledge of bacterial biologics and regulations pertaining to early and late phase pre-licensure activities. Must have working knowledge of GMPs and application to preparing clinical materials. Must be well-organized, work with minimal management and meet aggressive timelines. Utilizes knowledge of word processing software, strong writing and analytical skills to document software capabilities and functionality.Job Responsibilities:**This position is working in the CMC area. Relevant experience is requiredExperience: 3 to 6 yearsExperience with drug/biologics licensurePrior regulatory experienceTechnical writing experience (CMC experience )Scientific background,Required Skills:CMC/ Regulatory writing experienceScientific background, vaccines preferredMicrosoft Office (word, excel, powerpoint)Documentum ApplicationsTrackwise ApplicationsICH GuidelinesGMP experienceExperience with drug/biologics licensurePrior regulatory experienceEducation:BS in Biology/Chemistry or related fieldQualificationsBSAdditional InformationFor more information, Please contactAkriti GuptaOffice: View phone number on click.appcast.io | Fax: 973.998.2599SummaryType: ContractFunction: Writing/EditingExperience level: Mid-Senior LevelIndustry: Pharmaceuticals