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Title : MKG- Documentation Process Specialist II -111
State : New Jersey   Date : Sep 23, 2020
Experience Level :  
Position Type : Documentation Process Specialist II      
Description
This position is for a leading pharmaceutical company. Below are the details of the engagement. If you are available and interested please send me your updated word resume & your expected hourly rate on W2 ASAP.
Looking forward to hearing from you soon.

Work Location: Rahway, NJ

Job Title: Documentation Process Specialist II

Duration: 12+ months (extendable) contract on W2


Duties: 

As part of Global Labeling Therapeutic Areas group, and under the supervision of the Global Labeling Strategic Director (GLSD), the Global Labeling Specialist (GLS) is responsible for supporting the Global Labeling Lead (GLL) for developmental and marketed products, globally. This includes collaboration with the GLL to assist with operational activities related to end-stage management and finalization of the CCDS and US labeling, including associated patient labeling documents. The GLS is also responsible for operational aspects in support of local country affiliates for the development and maintenance of the EU and most of world labeling. 

Responsibilities may include, but are not limited to: 
Overall accountability for the end-stage management and finalization of labeling documents for assigned products including CCDS, US labeling, and their associated patient labeling documents, and target product labels. Includes the responsibility to work with the GLL and Global Labeling Operations Specialist (GLOS) to finalize proofing and compliance reviews and to progress documents through the Document Management and Labeling Workflow Management Systems. 
Performs final operational steps for the progression of documents on assigned products in order to ensure quality and compliant labeling documents are produced in a timely manner according to internal operating procedures and external regulatory requirements. Includes providing support required for audits/inspections related to assigned products. 
Provides updates to labeling tracking reports and databases. Provides updates to data included in spreadsheets. Documents meeting minutes in the Labeling Workflow Management System. 
Supports the use and development of current and new tools, technologies, and processes to support efficient global label development and worldwide submissions and approvals.

Experience: 

Required Experience and Skills: 
Minimum of 4+ years pharmaceutical/biological experience working with pharmaceutical labels. Proactive motivated individual willing to drive results. Detail oriented, well organized, and excellent prioritization skills. Strong Record of working with cross functional teams; collaborative in spirit. Strong skills in process mapping. Strong skills with MS Word and Excel - able to easily and effectively complete formatting tasks in Word and Excel. 

Preferred Experience and Skills: 
Understanding of Labeling terms and general concepts 
Proficiency with MS Office, especially Word, Excel 
Ensuring adequacy of process documentation output

Education: Require Bachelors Degree in Scientific discipline.



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Many Thanks,   

Sree Kanth
Recruitment Manager
Sree@newageclinical.com

NewAgeSys, Inc.
Direct: 609-945-1736 Fax: 609-228-4079
600 Alexander Rd, Suite 3-3 
Princeton , NJ 08540 
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