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Charlotte Manley

Charlotte Manley

Associate Product Development Analyst

Covidien

Florissant, MO

Associate Product Development Analyst at Covidien/Mallinckrodt

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Mallinckrodt (formerly Covidien)

Associate Product Development Analyst

•Responsible for gathering and storing documentation; maintain file sharing sites for projects with accurate and searchable / accessible project documentation.
•Gather, process, and report project data to the appropriate program management process.
•Manages cross-functional task achievement as needed.
•Provide project support to Project Managers as required, including scheduling, coordinating and facilitating team and sub-team meetings, documenting decisions, decision rationale, and action items, and preparing progress updates and reports.
•Constructs, updates and maintains project plans, timelines, resources, spending forecasts, charters, and schedules. Assists Project Managers in tracking and monitoring project progress to achieve project management stage deliverables and project milestones.
•Works with teams to construct and maintain contingency plans to address potential changes in project scope, timeline or budget projection.
•Assists project core team members in preparations for Design Stage Reviews.
•Authors suggested changes to product development and project management procedures based on knowledge gained during projects and submits to Program Management (Systems).
•Assists with the tracking of project requirements (Laboratory, Legal, Regulatory, etc).
•Assists in the preparation of reports and presentations to Management.

Career medium 02
Career
Career medium 03

Covidien

Drug Safety Coordinator

Collect and accurately document, assess, code and process adverse event reports related to the marketed drug products monitored by Covidien Drug Safety within the time frames established and in compliance with FDA requirements as well as ensuring Covidien quality standards are met prior to submission to regulatory bodies. Serve as a primary contact point and recipient for serious and non serious adverse events. Manage processing and reporting of serious adverse events received during Covidien sponsored clinical trials. Responsible for handling related safety inquiries for internal and external customers. Establish and maintain a positive mutual relationship with Covidien personnel, global and domestic involved in pharmacovigilance, and to ensure global compliance

Career

Covidien

Product Monitoring Coordinator

Monitor and manage the computer database for over seven hundred (700) global Imaging and Pharmaceutical users while serving as administrator with strict adherence to CMP, SOPs, FDA, and ICH regulations.

Support Surveillance Specialists with providing up-to-date, unbiased technical and clinical medical information for internal and external clients in order to assure the safe and effective use of the products in the field. Knowledge of FDA regulations and guidances in the area of complaint handling for pharmaceutical products and medical devices.

Career medium 04
Career

Lindenwood University

Bachelor's degree, Business Administration and Management, General