Michele T. Email & Phone Number

Princeton , Nj, Us

Princeton , Nj, Us

• Global development of E2E labeling process to support commercial and pipeline programs in the rare disease space.• Worldwide project management of labeling artwork process and responsible for the development, review, approval, and timely implementation of packaging components worldwide.• Reduced supplier artwork preparation turnaround times from 60+ days to 6 days, improving artwork coordination and approval timelines by 90% and reaching implementation targets on time.• Prepare responses to Health Authority information requests / queries / LoQs.• Independently author packaging Exemption Requests.• Lead labeling team on strategy for artwork content development, labeling artwork layout, and document lifecycle management. • Manage the artwork QC process for global markets.• Review and annotate reference documents for new artwork initiatives and global expansion.• Contribute to labeling content authoring and attend labeling governance meetings to determine final labeling text.• Support regulatory submissions and review / QC eCTD content prior to submission.• Provide regulatory labeling impact assessments for change control records and labeling deviations.• Manage labeling Quality Event / CAPA tracking.• Creation of annotation repository for consistent artwork annotations across brands.• Build process framework to support artwork development and implementation.• Manage continuous improvement initiatives and optimization of business practices associated with E2E labeling.• Support translation projects worldwide and Linguistic Reviews for MAAs and ongoing variations.• Raise CCDS change events in eDMS and ensure company position is rolled out to printed labels globally.• Review and approve global printer proofs; review, approve, and troubleshoot SPL.

Dublin, Ie

• Provide pharma clients with strategic and technical regulatory labeling services.• Collaborate with cross-functional working groups to pull information from multiple departments into a final label.• Manage distribution and tracking of label updates post-submission and for maintenance products.• Author and manage worldwide labeling content, CCDS deviation reporting, and labeling compliance metrics for orphan drug, respiratory, hematology, and neuro products. Provide strategy for eliminating deficiencies.• Resolve labeling deviations by initiating label change controls and distributing compliance updates to local teams.• Proofread eCTD module 1 and 3 documents, QC SPL, USPI, Med Guide, IFU, PIL, and packaging components for submission.• Research and present on competitor labels and packaging to strategize approach to new product design.• Manage SPL for drug listing and establishment registration activities; allocate NDCs and GTINs for new products.• Author responses to FDA during Requests for Information and Label Negotiations.• Manage eDMS regulatory document / SOP lifecycle and source, design, and implement Artwork Management System for packaging artwork version control, including vendor management.• Interpret and apply Regulatory packaging requirements to minimize medication errors, ensure safety, and determine final layouts based on FDA / EMA regulations and guidance.• Support artwork development and authoring packaging documents for new drugs / submissions / maintenance activities. • Approve packaging artwork materials and advertisement and promotional materials for US and EU with a 100% compliance rate.• Networking with industry contacts for business development opportunities and client relationship management.• Identify project scope, conduct needs assessments, and propose additional services for new and existing clients.

Cambridge, Cambridgeshire, Gb

• Managed label development and implementation for US respiratory drugs and vaccines. • Determined scope, downstream impact, and evaluated risks for labeling changes for US market.• Independently managed commercial labeling lifecycle, assessment of changes, and implementation for NDAs, BLAs, supplements, and annual reportable changes.• Researched and interpreted US labeling regulations and provided tactical and strategic guidance to cross-functional product teams regarding regulatory requirements, text placement, and implementation timelines.• Labeling and printed artwork SME for cross-functional working groups, including the label working team, packaging working group, artwork design development group, and implementation planning committee. • Supported product launch planning by partnering with Package Engineering, Manufacturing Sites, Commercial Marketing, and Supply Chain to ensure smooth product launches, brand line extensions, and product labeling maintenance/lifecycle activities.• Managed version control of draft labeling documents and performed final regulatory labeling and artwork approvals for a portfolio of respiratory, oncology, vaccines, and CNS products.• Managed annual reports, blanket no-change certifications, and authored labeling deviation reports.• Position staffed by Artech Information Systems.

Satellite Beach, Florida, Us

• Provided ANDA Submission support for pharmaceutical clients including artwork development activities. • Authored labeling and packaging SOP library for compliance with FDA guidance prior to site inspection / audit. • Established labeler codes, created master data, and assigned NDC numbers / GTINs to new products. • Responsible for monitoring RLD products for updates to ANDA labeling.

Dublin, Coolock, Ie

• SME consultant hired by former manager to lead printed labeling artwork projects within a cross-functional label working group.• Managed validation artwork projects for drug development projects.• Ensured packaging maintained quality standards, followed Health Authority regulations, and met printing requirements.• Approved all labeling artwork and printer proofs for the US and Canadian markets.• Position staffed by AllSource PPS.

Dublin, Coolock, Ie

• Labeling artwork project lead, managing high-profile packaging artwork and ad/promo projects for OTC, Rx, and device products.• Managed labeling artwork for over 20 successful product launches.• Collaborated with cross-functional stakeholders in label working groups to implement labeling and packaging for US and Canada.• Effective project management; ensured 100% on-time deliverables and labeling consistency across brands.• Worked directly with Packaging Development to design and implement innovative security technologies such as holographic overlays, RFID, and microtext to reduce counterfeiting by 40%.• Leveraged proofreading skills to spot issues in artwork components prior to print, which reduced rework by 33%.• Pursued opportunities for continuous improvement to ensure labeling artwork was right the first time.• As the Artwork Management System Administrator, conducted training, system implementation, upgrade validations, and responsible for maintaining the digital artwork asset library for Worldwide use.• Promoted to increasingly senior positions in 2009 and 2014.

Dublin, Coolock, Ie

• Authored Raw Material Certificates of Analyses, Manufacturing Record templates, Formula Records, Test Methods, and Quality Control Reports, Quality Policies, SOPs, Work Instructions, deviation memos, scientific documents, and change controls.• Supported Clinical Operations to ensure Quality documentation was available in advance of study start.· Position staffed by Kimco staffing.

Dublin, Coolock, Ie

· Supported clinical operations group during a documentation project for BOTOX.· Position staffed by Kimco staffing.

Us

· Assisted staff of eight in all aspects of conducting ophthalmic clinical studies.· Improved clinical inventory-tracking system to reduce spend by 20%.· Managed proofreading and editing for scientific documents from Medical Writing, including clinical study protocols and investigator brochures.

· Supported clinical research studies for GI and respiratory therapeutic areas.