DIANA MANOUSSAKIS

* ******** *****, *******, *** Jersey · 201-***-****

ad3jw1@r.postjobfree.com · https://www.linkedin.com/in/diana-manoussakis-1686bb11/ Highly organized Senior Project Manager in Pharmaceutical Artwork and Labeling industry. Exceptional interpersonal and leadership skills, with the ability to gain consensus and provide positive solutions between parties of different interests in cross functional labeling teams. Proven track record of using organization, fast thinking, and attention to detail. Strong work ethic and process oriented professional with emphasis on reliability and teamwork.

EXPERIENCE

MARCH 2023 – SEPTEMBER 2023

SENIOR ARTWORK AND LABELING MANAGER

MODERNA

● Own the development and implementation of international commercial labeling changes for assigned products.

● Manage labeling changes with cross functional team members: commercial, regulatory, quality, manufacturing, supply chain, etc.

● Manage and prioritize the work of our artwork provider for creation/updating of artwork files.

● Manage routing of artworks for internal Moderna approvals

● Review/Approve artwork files and printer proofs to ensure content is accurate.

● Resolve printing related issues with manufacturing sites and printers.

● Work with packaging and manufacturing sites to ensure labeling inputs are clear (die lines, coding areas, timings, etc.)

● Develop labeling documentation - SOPs, Work Instructions, etc. FEBRUARY 2016 – MARCH 2023

GLOBAL PACKAGING/LABELING PROJECT MANAGER

ASCENSIA DIABETES CARE (FORMERLY BAYER DIABETES CARE)

● Successfully worked on a large rebranding project for Ascensia’s Blood Glucose Meters.

● Consulted with the Ascensia and Country leads to develop overall timelines, and markup previous components according to new rebranding updates and initiated artwork development with artwork vendors, SGK and RR Donnelley.

● Worked in conjunction with country Marketing and Regulatory in departments to prepare all documents for approvals in EMEA, EU, LATAM and APAC regions.

● Simultaneously managed 5+ projects from 1-25 components, ensuring FLC date is met. Components consisted of Meter Cartons, Reagent Cartons and Labels, Multiple Language User Guides, Quick Reference Guides, Warranty Cards, Lancet Packaging, Meter Labels and Shipper Label Graphics.

● Ensured every step of the intense graphics process was met, to ensure compliance with FDA, EUMDR and IVDR mandates from each country for audit trail.

● Worked with the Translation and Content Department to acquire translated copy for each individual component for CMS purposes.

● Requested and secured estimates. Managed project scope changes, to ensure financial release is attained before each job commences. Used expertise with pre-scoping and routing to minimize costs of each project for the country.

● Clearly communicated timing and scope changes to country reviewers and cross functional partners.

● Managed the receipt of all required documentation (internal specs, address templates, Bayer Art Numbers).

● Directed projects flow through the Design Management Center, SGK, RR Donnelley and the internal SKU/project tracking system.

● Ensured every change was proofread by internal proofreaders certifying compliance and minimizing changes.

● Managed the release of artwork for prepress. Provided clear, concise direction to both SGK and RR Donnelley.

● Provided changes to the Bill of Materials, by providing Packaging R&D and Procurement of BOM Markups, for future use.

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● Facilitated project activation meetings with all countries and personnel involved. 2015-2016

SENIOR PROJECT MANAGER

GSW WORLDWIDE

● Responsible for Eli Lily Global account (CYRAMZA) for three indications.

● Developed scopes of work and schedules using MS Project.

● Developed estimates and timelines and informed team members at project kickoff meetings.

● Knowledge of digital processes including website updates, banner ads and iPad applications.

● Set clear expectations for tasks and deliverables.

● Managed client ECRM platform for the agency to upload projects for Medical/Legal reviews. 2014-2015

SENIOR PROJECT MANAGER

SENTRIX HEALTH COMMUNICATIONS

● Responsible for Otsuka Pharmaceuticals (Abilify Maintena), Johnson & Johnson (Listerine) and various Eli Lily medical education projects.

● Developed scopes of work and schedules using MS Project.

● Effectively managed two launches for Abilify Maintena for two new indications.

● Developed estimates and timelines and informed team members at project kickoff meetings.

● Knowledge of digital process including website updates, banner ads and iPad applications

● Partner with finance to track burn rates, budget tracking and financial reporting. 2013-2014

SENIOR PROJECT MANAGER

THE CEMENT BLOC

● Responsible for BMS/Pfizer (Eliquis US), Salix Pharmaceuticals (MoviPrep, Apriso, OsmoPrep), SOBI (Kineret, Kepivance) and AstraZeneca Managed Markets Payer brands.

● Train, manage and develop two project coordinators.

● Successfully managed all projects from inception to completion including manuscript, layouts, client mailings, visual aids, complex toolkits containing many components to ensure that projects are delivered in accordance with client specifications. EDUCATION

BACHELOR OF BUSINESS ADMINISTRATION, MARKETING MANAGEMENT BARUCH COLLEGE OF THE CITY UNIVERSITY OF NEW YORK

CERTIFICATION

REGULATORY AFFAIRS PROFESSIONAL SOCIETY (RAPS) MEMBER MEDICAL DEVICES AND PHARMACEUTICALS REGULATORY AFFAIRS DUAL CERTIFICATE EXPECTED COMPLETION DATE: March 2024

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