Regulatory Affairs Specialist V (5608050) Job at Artech, Swiftwater, PA

  • Artech
  • Swiftwater, PA

Job Description

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: 973.967.3409 | Fax: 973.998.2599SummaryType: ContractFunction: Writing/EditingExperience level: Mid-Senior LevelIndustry: Pharmaceuticals

Job Tags

Work at office, Immediate start

Similar Jobs

Soliant

School-Based SLP: Teletherapy & IEP Impact Job at Soliant

 ...success.Responsibilities include assessments, treatment, progress monitoring, and collaboration with educators, counselors, and families. Both onsite and teletherapy options are available, with thorough documentation and compliance emphasized.#J-18808-Ljbffr Soliant

D3S Service LLC

Appliance Repair Technician Job at D3S Service LLC

 ...more ($60,000-$85,000) once route and speed builds up. ABOUT SLOAN APPLIANCE: We're a factory-certified service provider for Samsung, GE, Electrolux, and Bosch - meaning manufacturers send their warranty and service work directly to us. That steady pipeline of work... 

UPMC Southwestern PA

Emergency Medicine- UPMC Multiple locations throughout PA- Competitive Salary Job at UPMC Southwestern PA

Why UPMC? Over the last 20 years, UPMC has ushered in a new era of health care excellence in Pittsburgh, western Pennsylvania, and locations around the world. UPMC has evolved from a single psychiatric hospital into a $21 billion integrated global health enterprise closely... 

Lutron Electronics

Government Relations Manager Job at Lutron Electronics

OverviewLutron is seeking an influential Government Relations Manager out of our Conshohocken, PA office location. In this role, you will...  ...legislative, regulatory, and industry forums.Develop policy materials, including briefing papers, comment letters, and testimony.... 

Labcorp

Phlebotomist Job at Labcorp

 ...Labcorp is hiring a Phlebotomist for its Boston location to perform blood collections, handle specimen processing, and provide patient service...  ...Provide customer service and perform administrative duties; travel to additional sites as needed Requirements High school...