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Pharmaceutical Industry

Location:
Deerfield, IL, 60015
Posted:
September 27, 2023

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Resume:

Daniel Tolari

**** ********* **, *********, ** **015

Phone: 847-***-**** - Email: adz0ae@r.postjobfree.com

PROFESSIONAL EXPERIENCE

Astellas Pharma Northbrook, Il

Proofreading Oct 2022 to July 2023

Managed the proofreading for all promotional and sales training materials

Responsible for detecting and correcting errors in written documents

Checked written text for misspellings and inaccuracies

Annotated errors found electronically using Adobe Acrobat

Ensure production proofs matched final approved electronic version word-for-word

Skilled in Adobe, Word, Excel, Veeva, Auto Proof Pro, TVT (Text Verification Tool)

Fresenius Kabi Lake Zurich, Il

Proofreading Oct 2020 to May 2022

• Managed the proofreading of labeling files at all stages in the development life cycle

•Responsible for detecting and correcting errors in written documents

•Checked written text for misspellings and inaccuracies prior to publishing

•Read manuscripts before they are typeset to find and correct mistakes; read through typescripts to detect and highlight typographical or grammatical error.

•Read original copies of a manuscript against typeset proof to catch typing mistakes

•Check typeset documents to ensure the publisher used the font style, size, and text spacing specified on the original copy by a page designer

•Mark corrections by editors or authors on a master set of proofs which were returned to typesetters for correction

•After correction by typesetters, responsible for checking typeset proof against reviewed copies one final time before printing

Mazzetta Company, LLC Highland Park, Il

Logistics Associate July 2019 to March 2020

Responsible for managing and placing all orders to meet distribution timelines for wholesalers and restaurants

Ran inventory reports to ensure appropriate inventory is available to place orders to meet distribution timelines

Responsible for reviewing all purchase orders in order to maintain inventory

Sole individual tasked with managing and resolving all trucker invoice issues

Worked with multiple logistic companies to ensure timely delivery of all goods at the most cost-effective pricing

Organizing and managing inventory storage and transportation

Ensuring the safe and timely pick up of shipments

Monitoring shipments, cost/pricing and timelines

Answering customer queries

ATHENEX, INC. Schaumburg, IL

Senior Labeling Associate August 2017 to December 2018

•Interfaced with CMO’s and internal stakeholders to create and update label copy for FDA submissions or to respond to deficiencies or RLD updates.

•Supported labeling manager in maintaining the quality systems for labeling (barcode assignments, NDC assignments, version control at all lifecycle stages, change controls, file management, and the review, maintenance, management, and version control of SPL files for drug listing, submissions, and establishment registrations.

•Identified process improvements and updated SOP’s, work instructions, and checklists accordingly.

•Supported management in maintaining quality systems for labeling (barcode assignments, NDC assignment, label master index, change controls, document versioning, file management etc.)

•Managed all aspects of formatting and editing label copy in accordance with FDA guidelines and regulations.

•Managed process of updating labeling based on partner or FDA requests in an accurately and timely manner.

•Managed the review and proofreading of labeling files at all stages in the development life cycle (including submission, deficiency, launch, and commercially available labeling) and understanding unique requirements at each phase.

BAXALTA, INC. & SHIRE Bannockburn, IL

Manager, Regulatory Affairs CCDS/CCSI May 2015 to October 2016

•Responsible for assuring local and regional prescribing information is maintained, accessible and compliant by managing, tracking, and version control of Company Core Data Sheets

•(CCDS)/Company Core Safety Information (CCSI).

•Monitor applicable global regulatory and labeling requirements; assure compliance with company and external standards and help drive implementation across functions and projects.

•Responsible for monitoring global implementation of CCDS/CCSI revisions into country specific labeling.

•Maintain change control history of all new and revised CCDS/CCSI revisions.

•Managed all aspects of establishing and maintaining metrics for CCDS implementation.

•Managed processes that create and maintain CCDS and Company Core Safety Information (CCSI).

•Maintain the CCDS intranet site to provide access to current CCDS/CCSI revisions and history.

•Interact with technical experts, local product owners, international product owners and Regulatory Centers of Excellence.

ASTELLAS PHARMA GLOBAL DEVELOPMENT Northbrook, IL

Senior Labeling Associate May 2006 to May 2015

•Developed, maintained, and implemented prescribing information and printed packaging components for the United States, Latin America, and Canada.

•Led labeling development teams for Latin America product launches and ensured that all labeling met company and regulating health authority specifications.

•Assured compliance with Company Core Data Sheets by evaluating all CCDS changes and implementing according to prescribed timelines.

•Provided expertise to labeling development teams on applicable regional health authority requirements.

•Managed English Master Documents and translation of labeling text into local languages according to individual country requirements.

•Assured the compliance and accuracy of prescribing information on company intranet website and product specific websites.

•Prepared the labeling component and summary of changes for all annual reports.

•Organized, compiled, and maintained all documentation and assured compliance of manual and electronic label history files.

•Established strong working relationships with cross-functional review team members, affiliates and business partners.

•Controlled all product codes, barcodes, NDC and part numbers for all products, and ensured that no duplication occurred.

•Coordinated and provided guidance to typesetters for the preparation of artwork for all labeling.

ABBOTT DIAGNOSTICS DIVISION Abbott Park, IL

Labeling Coordinator January 2002 to February 2006

•Generated change requests for controlled documents.

•Worked proficiently in ADD Manufacturing Management to check inventory, shipping and additional information for products.

•Worked competently in Document Management System to author and revise documents.

•Trained incoming Proofreaders and Label Editors.

•Assisted with writing revisions to operating procedures.

•Scheduled all various types of proofreading to both proofreaders and senior proofreaders.

ABBOTT DIAGNOSTICS DIVISION Abbott Park, IL

Senior Proofreader August 1999 to January 2002

•Proofread all ADD labeling copy at various stages.

•Provided highest level of customer service while adhering to operating procedures.

•Functioned as part of a collaborative effort with Label Editors, Proofreaders, Desktop Publishers and international affiliates, to ensure creation of on-time & error-free multilingual labeling for all products.

•Ensured timely distribution and availability of printed inventory to U.S. and international customers through maintenance of inventory levels.

ABBOTT PHARMACEUTICAL PRODUCTS DIVISION Abbott Park, IL

Production Operator June 1997 to August 1999

•Completed various tasks on liquid filling and finishing lines including inspecting, packaging, labeling, and kit assembly.

•Operated filling, capping, and labeling equipment on liquid manufacturing lines.

•Maintained a safe working environment by reporting hazards and correcting unsafe practices.

•Recommended quality and productivity improvement for various lines.

•Instructed and assisted less experienced production operators.

ABBOTT DIAGNOSTICS DIVISION Abbott Park, IL

Warehouse Servicer June 1996 to June 1997

•Audited products for accuracy in pick and pack operations prior to shipping to the external customer. Achieved a 99.99% picking accuracy vs. department average of 99.94%.

•Adhered to operating procedures and good manufacturing practices to ensure safety and quality through the distribution process.

•Processed replenishments from primary reserve to forward pick location via radio dispatch.

EDUCATION

Western Illinois University, Macomb, Illinois

Bachelor of Arts May 1996

Major: Communication

Minor: Marketing



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