Sales Project Management
Resume:
Dale Iannetti
Middlesex, NJ *****
908-***-**** (Home) or 908-***-**** (Cell)
*******@*****.***
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