*Hi,*
*Hope you are doing well…* *Please let me know your feedback…* *Position: Labeling Analyst* *Location: Somerville, NJ* *JOB DESCRIPTION** - Labeling Analyst (Pharma/ Medical Devices)* Labeling Analyst will work in collaboration with Client SPOC and all the concerned Stakeholders and will be responsible for below mentioned activities: *DUTIES/RESPONSIBILITIES:* · Understanding and mapping of current labeling process, tools and systems · Understand and gather labeling needs of the client · Provide SME support to the business stakeholders for labeling solution · Provide Labeling Platform Technical expertise · Follow up with SMEs and stakeholders to ensure timely inputs and approvals · Understanding Global Regulatory requirements of Medical Devices/Pharma Labeling - Act as Syntel’s Single Point of Contact (SPOC) for the respective business areas - Proactively communicate project status, issues & risk to management. - Provides leadership and direction, championing departmental or cross-functional Labeling initiatives. - Responsible for the overall Planning, scheduling, estimations, direction, coordination and evaluation of the Labeling process. - Use technical/compliance information to guide and influence Labeling Compliance strategies. - Responsible for planning, assigning, directing work; addressing Labeling issues and resolving problems. - Monitor investigations and approvals to ensure that all the required information is captured and documented with relation to this project. - Drive timely execution of Project deliverables through monitoring and reporting status to Labeling owners and management. - Create and own Change Orders in PLM to route and release documents · Create Summary of Changes - Create redlines on artworks and documents of changes and to send to graphic designers. - Review with cross functional stakeholders · Initiate IFU changes and follow up with vendors including language translations - Analyze trends to monitor the effectiveness of the process and drive remediation for improvement - Resource management. *EDUCATION and Experience* · B.S. /M.S. in Engineering or equivalent with 8+years of experience in Life sciences or Medical Devices processes / projects especially in Product Labeling. · Strong knowledge in Medical Device Labeling · Project Management experience in labeling is a preferable *Looking forward to have a fruitful Business relationship with you and your company!!* *I apologize if this mail created any inconvenience to you..* *Thanks & Regards.....* *Arif Khan* *Technical Recruiter.* *[image: LOGO]* *[email protected]* <[email protected]> *GTalk: [email protected] <[email protected]>* *Centraprise Corp Edison , New Jersey.* *3 Ethel Rd,Suite # 304. Direct: **6093570797 Ex : 459* *Fax :(732) 626 6289* *Minority Owned (MBE) Certified* -- You received this message because you are subscribed to the Google Groups "Exact Match" group. To unsubscribe from this group and stop receiving emails from it, send an email to [email protected]. To post to this group, send email to [email protected]. Visit this group at https://groups.google.com/group/exact-match. For more options, visit https://groups.google.com/d/optout.
