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Reference # : 18-01662 Title : Senior Associate II -TMF
Location : Cambridge, MA
Experience Level : Start Date / End Date : 02/19/2018 / 12/31/2018  
Description
DESCRIPTION:
Artech is currently seeking to add to the below position
 
Job Description:
Job Title: SABR Associate II
Job ID: BIIBJP00009346
Location: Cambridge, MA
Duration: 10 Months
Description:
Safety and Benefit Risk Management, Quality and Compliance, Process and Records Management (SABR QC PRM), Senior Associate II 
The Senior Associate II liaise and collaborate with members of the client team and other client functions to manage the Safety Trial Master File (TMF). 
ESSENTIAL JOB FUNCTIONS:
• Maintains activities for Safety and Benefit Risk paper TMF archival strategy 
• Supports Document Quality and Completeness Review 
• Ensures oversight for inspection readiness of Safety TMF documentation 
• Updates Safety collection templates and forms as needed 
QUALIFICATIONS: 
Education 
B.A. or B.S. degree or equivalent experience desired, science degree preferred 
Experience 
3 years of experience in the pharmaceutical / biopharmaceutical industry, medical, or life sciences highly desired 
• Knowledge of FDA expectations is essential 
• Knowledge of Post-marketing and Clinical Trial Pharmacovigilance regulations 
• Direct experience in GCP compliant quality systems and data management 
• Regulatory affairs, quality assurance or clinical departments experience is preferred 
• Understanding of Lean Six Sigma process principles desired 
Skills 
• The employee must have strong knowledge of pharmaceutical R&D regulatory affairs, technical writing skills, data management skills, archiving, drug safety knowledge, meeting facilitation and documentation skills. 
• The employee must possess ability to exercise some latitude in determining objectives and approach to work assignment to maximize compliance, strong organizational skills, attention to detail, and technical skills, e.g., Microsoft Programs (Excel, Access and Word), Visio, and Adobe Acrobat Pro. Familiarity with ARISg
 
Please apply on our company website (www.artechinfo.com) with reference to job ID, or contact me at nisha.samuel@artechinfo.com / 973.967.3540
 
Nisha Samuel
Assistant Manager- Staffing

Artech Information Systems LLC
360 Mt. Kemble Avenue, Suite 2000 | Morristown, NJ 07960
Office: 973.967.3540 | Fax: 973.998.2599
Email: Nisha.Samuel@artechinfo.com | Website: www.artechinfo.com

 
About Artech Information Systems LLC
Artech is an employer-of-choice for the last 25 years to over 7,500 consultants across the globe. We recruit top-notch talent for over 70 Fortune and Government clients coast-to-coast across the U.S., India, and China. We are #1 Largest Women-Owned IT Staffing Firm in the US and this may be your opportunity to join us! For more check: www.artechinfo.com
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