Belinda Eason Darke Email & Phone Number

Apex, NC, US

Cambridge, MA, US

Solely responsible for 70+ US marketed and ~9 US developments products for US labeling operationsProvide oversight to 2 FTE labeling operations specialists in Sanofi PasteurOversee assignment of NDCs, coordination of manufacturer drug listings, establishment registrations, BNCC, and additional ERDL coordinator responsibilities performed by a.

Paris, France, FR

Regulatory packaging SME in packaging task force (development products) and labeling working group (marketed products)Provide regulatory approval of all new/revised packaging componentsEnsure all current and new packaging remains aligned with FDA regulations and guidanceQuality control of documents for FDA submission, including proofreading and correction.

Proofread various English and non-English pharmaceutical inserts for client as needed

Lawrence Township, NJ, US

Prepared USPI markup/annotated, clean, and SPL for submissionsPerformed Drug Listing UpdatesCoordinated transfer of labeling files for mature products to third party vendor, which includes identifying files necessary for transfer, ensuring correct documents are in files, and providing product activity updates for turnover to third party vendor.Proofread.

Lawrence Township, NJ, US

Prepared USPI markup/annotated, clean, and SPL for submissionsProofread US and Export product inserts and packagingPerformed multiple-document cross reads during FDA negotiationsPrepared labeling change markups for Export LabelingProofread CCDS against CFLT editsCreated model documents for export submissionsConverted SPL from XMLSpy to i4i’s A4L XML.

Edited, proofread, and fact checked articles for a monthly publication of the nonprofit group Bangkok Mothers and Babies InternationalCollaborated with the Editor and printer on matters of content and layout

Edited, proofread, and fact checked travel articles for a magazine published quarterly by the American Women’s Club of Thailand

Lawrence Township, NJ, US

Coordinated updates of US product labeling for submission to HA, ensuring adherence to internal SOPs and federal regulationsComanaged the coordination of the conversion of USPI to Structured Product Labeling (SPL)“Sectioned” USPI in preparation for initial SPL conversion by vendorTrained 2 contract proofreaders and managed their workloadsPerformed final.

Lawrence Township, NJ, US

Coordinated updates of US product labeling for submission to HA, ensuring adherence to internal SOPs and federal regulationsCoordinated label updates with third-party interestsMaintained Global Labeling and Promotion Compliance websiteProofread product labeling, promotional materials, and company core data sheetsDecember 2005, PRI STAR AWARD: Bristol-Myers.

Tinton Falls, NJ, US

Assisted staff accountants and maintenance manager with proofreading, invoices, preparing software maintenance quotes, processing customer POs, and compiling maintenance contracts.

Boston, MA, US

Proofread pharmaceutical-related documents, including training modules, product information inserts, slide kits, product packaging, marketing materials, and various types of advertisements.Ensured that all documents were correct grammatically, formatted correctly, and met accepted style and FDA regulations.

Ba, English/Sociolinguistics

Education record