*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*

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