Grace C. Russell

**** *. ****** **, ******* Hills, FL 215-***-**** adnsb9@r.postjobfree.com

Professional Experience

Document Publication Specialist

Janssen Pharmaceuticals (Kelly Svcs) REMOTE (Aug. 2018 thru July 2021)

Provide documention and publication support for abstracts, encore abstracts, posters and manuscripts for entire Scientific Communications Immunology Publications group across all products using Janssen’s Scientific Publications Workflow Automation System (JPUBS) for therapeutic areas: Dermatology, Rheumatology and GI.

Circulate and coordinate the internal review of publications, and document the reviews from: (a) Regulatory representative as per GDL-06016, and (b) CDTL, GMAL, Legal/Patent representative as per SOP-10100 and external authors in JPUBS.

Coordinate with Publication Team Leads to ensure vetted encore publications are planned, tracked in JPUBS, and adhere to established SOPs and timelines.

Ensure that the encore submissions and presentations adhere to encore congress requirements and criteria.

Maintain Author Contracts in Sharepoint and in JPUBS.

Senior Regulatory Operations Specialist III

Merck (NewAgeSys – Agile1) Upper Gwynedd, PA (Sept. 2016 thru Aug. 2018)

Divestiture and Deletion Coordinator

Order/Generate/Coordinate documents required (declarations, GMP Certificates, CPP's, etc.) to support regulatory filings from international subsidiaries and externals business partners

Maintain a close working relationship with external business partners to achieve timely submissions. Liaise with global health authorities, and third party vendors.

Track/Update filing status for product approval process in Sharepoint spreadsheets

Track metrics of submissions and deletions to present quarterly to management

Compliance Information Manager

McNeil Consumer Healthcare Fort Washington, PA (March 2014 thru June 2016)

Serve as compliance expert for external and internal partners and key stakeholders regarding Field Alerts and their submissions to regulatory authorities including Follow-up and Final Field Alert reporting per FDA regulations 21 CFR 314.81.

Identify commitments made through Field Alerts and coordinate with stakeholders to identify the method and timeliness for commitment remediation up through closure.

Maintain Master Recall Database list containing Lot, UPC and NDC numbers for 20+ McNeil OTC drug products.

Provided monthly status reports and termination requests to FDA for 100+ recalls for medical devices at Synthes in West Chester, PA.

Provide escalation to management Quality Metrics to Quality Council quarterly for all McNeil sites using downloads from the Escalation to Management Sharepoint site

Assist with the documentation of internal audit schedules, results and status of commitments identified resulting from those audits. Maintain Audits database in Sharepoint.

Complete monthly Annual Product Reviews for Field Alerts and Recalls from each site.

Maintain the Board of Health database that contains all communications with Regulatory agencies.

Compliance Information Specialist in Regulatory Compliance

McNeil Consumer Healthcare Fort Washington, PA (02/12 – 03/14)

Facilitate the management notification/escalation process. Led escalation meetings via WebEx to all sites and ensure the capture and tracking of meeting decisions to the Quality Review Board.

Follow up with FDA for termination of recalls of 20+ OTC McNeil products.

Maintain FDA-ready files of retained escalation records by interacting with stakeholders to obtain data for cataloging documents required to assure evidence-readiness, including documents associated with escalations such as Field Alerts and accompanying investigations, internal meeting minutes and escalation presentations to management.

Consultant Recall Coordinator in Regulatory Compliance

McNeil Consumer Healthcare (thru Validant) Fort Washington, PA (02/11 – 02/12)

Serve as liaison to regulatory authorities regarding recall activities and provide monthly status reports to FDA for 20+ recalls of OTC products. Knowledge of FDA regulations 21 CFR 210, 211 and 820.

Compile and submit Attachment B document to FDA within 10 days of execution for each recall

Maintain Master Recall Database list containing Lot, UPC and NDC numbers

Direct recall activities with Stericycle (McNeil’s contracted recall service provider)

Maintain PO database for Stericycle fees for each recall

Identify commitments made through Field Alerts and coordinates with stakeholders to identify the method and timeliness for commitment remediation

Document and track all action items from escalation meetings. Verify slide deck is complete and next steps/final decision is made and upload slide decks into Sharepoint

Recall Coordinator in Regulatory Compliance/ Training Coordinator in Quality Management - Temp

Teva Pharmaceuticals Sellersville/Horsham, PA (10/09 – 01/11)

Coordinated the execution of recalls and withdrawals of 40+ generic prescription products.

Performed Effectiveness Checks on 40+ drug recalls and withdrawals per FDA

Processed product recalls of multiple Teva drugs following FDA guidelines and GMP utilizing Oracle Applications database to run monthly status reports

Assisted the Regulatory Compliance department with administrative responsibilities for document management of stock response forms from customers

Administered multiple Teva Lotus Notes databases and transferred electronic files from the Corporate PLIVA and Barr database web repositories

Administered Teva’s LMS Kaplan Eduneering’s ComplianceWire

Compiled and audited training records of employees following FDA compliance and GMP practices for data transfer to new Kaplan LMS System

Assist employees to assure accuracy of Position Skills Inventories that reflect all training

Administered Lotus Domino Blackberry server for hundreds of users in remote offices throughout the U.S.

Maintained project management schedules for IT projects using Primavera and the SCRUM iterative process

Education

M.B.A. Chapman University, Orange, CA

B.S. Computer Science State University of NY at Binghamton, NY

PMP Project Management Certificate Boston University, MA

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