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
Description:
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.
