Dale Iannetti

*** *** *****

Middlesex, NJ *****

908-***-**** (Home) or 908-***-**** (Cell)

acc1wb@r.postjobfree.com

Summary

Extensive experience in the Pharmaceutical Industry for Rx (CMC) and Medical Devices. Regulatory and

Quality Specialist with a broad background in Change Control Management/Electronic Drug Listings,

Establishment Registrations (Structured Product Labeling (SPL) and Drug Importation issues. Working

k nowledge of 21CFR Part 510, 207, 820, 210, 211. Skills also includes sales team support, database

administrator, process t rainer and analyst, project management, contract administration, budget

t racking and accounts payable/collections.

2013-Present Convatec, Skillman, NJ

Senior Change Control Specialist – Medical Device, Quality

Manages worldwide project changes that affect multiple sites and specifications to ensure business and system

compliance.

Interaction with numerous business units (R&D, Engineering, Regulatory Affairs) and fosters efficient processes.

Identifies areas of opportunity of change control process and submits solutions for improvement.

Attends weekly meetings of Change Control Board and manages the tracking and coordination of changes that

require Change Control Board approval.

Provides training and guidance on change control business and system processes

Supports the creation of monthly metrics to monitor the Change Control quality system.

2003-2013 Merck (Schering Plough), Kenilworth,NJ

Regulatory Specialist/Change Control Coordinator-Global Regulatory Affairs-CMC

Established SME for change control which includes t raining new hires, on-call help support and

metric reporting for numerous modules in the Trackwise change control system. Serves as a liaison

between GRA CMC, and various Global Business units to ensure compliance with business process.

T racks and evaluates domestic and international changes ensuring due dates were met on or before

required time frame. Participated on the integration team when new version of Trackwise was rolled

out in 2011 which integrated Schering Plough and Merck change control process.

Established SME for Rx Electronic Drug Product/API/Medical Device Listings, Labeler Codes and

D rug Establishment Registrations submissions for 48 sites utilizing SPL.

Coordinates the submission of the CMC portion of PDUFA fees for Rx products and establishments.

Coordinates the submission of GDUFA Self Identifications for sites that manufacture for Generic

p roducts.

Serves as a liaison with FDA Compliance Officers in the release of numerous drug shipment

detentions eliminating any impact on production. Provides on-going t raining to all business units

w ithin Merck regarding Import processes and submissions required for successful shipments into the

US.

Writes and updates all relevant SOPs related to Change Control and Drug Listing.

Supports the preparation of Rx product Annual Report for the CMC Section.

Contract Employee with Schering Plough

NJ Quality Operations Library Documentation Specialist with duties that included editing SOPs and

G MPs. Maintained proper storage and files for Schering procedures.

NJ Quality Laboratories – Prepared binders for 3 rd party auditors as required by the 3rd party auditor

p rotocol during the Schering Plough consent decree. Prepared topic templates, work process f low

charts and description of systems and planned enhancements. Ensured the accuracy and t imeframes

were met according to project schedule.

2002-2003 Union Co. Bd. of Ed. Union, NJ

Substitute Teacher

Provided ongoing t raining and motivation for students in the absence of their teacher.

2002-2002 Infotech East Hanover, NJ

Project Management Certificate/Internship

Completed Project Management, Business Analyst and Customer Relationship

M anagement certificate program.

Offered an internship – analyzed, updated and presented New Student Orientation.

U pdated and produced new student Project Management Manual.

Prepared and submit ted Request for Proposals for various t raining projects for the State

of NJ and NY.

1980-2001 Bell Latoratories/Telcordia Technologies Piscataway, NJ

Sales System Analyst/Trainer/Administrator

Served as primary contact for nine sales account teams while managing the day to day

operations of the Opportunities Database and overseeing the general direction of the

sales force automation effort. Responsible for t ranslating business needs into system

requirements, developed targeted user documentation and provided on-going sales tool

t raining to the sales organization.

Collections Specialist/Contract Administration

Prepared invoices, correspondence, reviewed contract billing terms and investigated

b illing history. Audited and reconciled accounts with Corporate Accounting created and

maintained spreadsheets to analyze accounts and wri te-offs.

Budget Specialist

Tracked $14.6M budget for Facilities Management group and Building Security.

Submit ted year-end projections, forecasts, calendarizations, accruals and variance

reports.

Administrative Support

Served as mailroom coordinator supervising the daily activities of outside contractors

performing mail carrier duties serving over 5,000 employees. Prepared reports analyzed

expenses and submit ted proposals for budget requests.

Administrative support for numerous technical business units (typing correspondence,

f iling, t ravel arrangements and conference coordination.

Education

Middlesex County College, NJ – Associates Degree in Business Management

Rutgers University, NJ – Coursework in Business Management

Union County College, NJ – Certificate in Marketing

Crestech University, NJ – Certificate in Project Management, Business Analyst and Customer

Relationship Management

Yellow Belt for Lean Six Sigma @Merck

Professional Memberships

D rug Information Association

Systems Experience

Trackwise, Documentum Platform, Orion Database

Contact this candidate