USA-Project Manager III (Clinical)

USA-Project Manager III (Clinical)

23 Dec 2021
New Jersey, Somersetcountynewjersey, 08901 Somersetcountynewjersey USA

USA-Project Manager III (Clinical)

Vacancy expired!


My name is

Yogesh Gathe and, I am a senior recruiter working with

Experis a part of

ManpowerGroup. I have an excellent and long-term opportunity with a direct client of ours. This opportunity is urgent and looking to move very quickly, please apply by sending your email or forwarding on to anyone you know who might be a fit. I am looking forward to connecting with you!

Job Title: Project Manager III (Clinical)

Location: Bridgewater, New Jersey 8807

Job Type: 6 Months Contract


Regulatory ERDL Coordinator:
Must have NDC, Establishment registration, GDUFA, NDC labeler and SPL for active ingredients.
This is a fully remote role!

Within Global Labeling, this position is responsible for:
Accurate assignments of NDC numbers for all CLIENT products, including manufacturer NDCs, except Pasteur
Prepares annual Blanket No changes Certification for Product and plant NDCs
Maintain database of current and historical NDC assignments, with periodic review of data to ensure accuracy and completeness
Reconcile NDC data from multiple sources
Maintain Establishment Registrations for all CLIENT, Genzyme, Ablynx, Bioverativ, Pasteur/Protein Sciences companies and plants; annual recertification and as changes occur during the year
Advises IA on requirements for third party manufacturer Establishment Registrations and liaises with third party manufacturers to ensure their Establishment Registrations are completed and up-to-date
Liaise with Supply Chain/Trade Compliance to resolve customs queries
Liaise with Pricing Team to resolve NDC issues
Prepares GDUFA establishment registrations
Prepares SPL for CLIENT Active Ingredient Solutions (SAIS) drug listings
Requests new or reassignment of NDC labeler codes
Ensures that all CLIENT entities that require an NDC labeler code are assigned an NDC labeler code
Coordinates registration and payment of fees for Device Establishment Registrations for CLIENT and Genzyme
Responsible for obtaining/updating DUNS number from Dun & Bradstreet, and maintenance and biannual validation of DUNS numbers
Prepares templates, and verifies NDCs, for the Distribution Data portion of each product's Annual Report
Serve as in-house SME for Lot Distribution Report questions/issues
Responsible for quarterly verification of FEIs and establishment data for TAA reporting purposes
SME on FDA requirements for SPL: stylesheet, document types, XML coding, etc.
Provide ad hoc support and training for SPL
Maintains plant Establishment Information in the Reed Tech Portal (for SPL)
Performs US Labeling Operations SPL-specific functions as needed
Performs other US Labeling Operations functions as needed (proofreading, etc.)

Required Skills:
SME-level experience and knowledge of FDA regulations and guidances for:
o Assignment of NDC numbers/changes to NDC numbers
o Manufacturer Drug Listing for Imports
o Annual Blanket No Changes Certification
o Medical Device Establishment registrations and fees
o DUNS numbers
o Establishment Registrations
o Labeler Codes
o Drug Product Distribution Data
o Biannual Lot Distribution Reports
o Understanding of the Trade Agreement Act (TAA reports)
o Structured Product Labeling and Drug Listing
Understanding of the pharmaceutical industry, drug packaging development, and labeling maintenance processes and objectives
Organizational skills: capability to work cross functionally (Industrial Affairs, CMC, Pricing, Trade Compliance, etc.), coordinate discussions, and reach objectives
Must be active and demonstrate initiative: capable of carrying out multiple tasks quickly and accurately
Must be precise and possess excellent concentration
Technical skills: Microsoft Office Suite with advanced Excel skills, Adobe Acrobat DC, XMLSpy, XML coding is a plus, Veeva, SharePoint, capacity to learn new tools, InSite for Viewing, eCTD
Ability to adapt quickly to changing priorities
Excellent oral and written communication skills

Minimum of 5-10 years as a Regulatory ERDL Coordinator, or performing all of the duties listed above, in the pharmaceutical industry. Experience working in an international environment is a plus.


Yogesh Gathe | Talent Acquisition Specialist | Experis CORE+

PhoneExt: 7184 ORExt: 7184

100 Manpower Place, Milwaukee WI 53212

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