Regulatory Affairs Specialist V (5608050)

Company Description

Artech 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 Description

Job 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 required
Experience: 3 to 6 years
Experience with drug/biologics licensure
Prior regulatory experience
Technical writing experience (CMC experience )
Scientific background,

Required Skills:
CMC/ Regulatory writing experience
Scientific background, vaccines preferred
Microsoft Office (word, excel, powerpoint)
Documentum Applications
Trackwise Applications
ICH Guidelines
GMP experience
Experience with drug/biologics licensure
Prior regulatory experience

Education:
BS in Biology/Chemistry or related field

Qualifications

BS

Additional Information

For more information, Please contact

Akriti Gupta

Office: 973.967.3409 | Fax: 973.998.2599