MONICA M. DIONNE
Objective- I have * years in the Pharmaceutical Industry.
The therapeutic area that I have worked in is Cardiology, Immunology, Diabetes, Obesity, Respiratory, Oncology, Neuroscience, HEOR.
KEYWORD SUMMARY
• Fast learner with excellent time management skills.
• Multi-tasking and Interpersonal skills.
• Proficient with Microsoft Word, Outlook Express, Lotus Notes, Group Wise, Novell, IMPACT, SAP, SMS SQ, ERP/JDE Edwards, Oracle Clinical, CTMS.
• Administrative Expertise.
• Receiving, Inspecting, Auditing
• Excellent Communication Skills
• Client Relations
• Material Control
• Purchasing
• Inventory Management
• GMP certified
• Organizational Skills
• Excellent Work Ethic
• Data entry
EDUCATIONAL BACKGROUND
BUCKS COUNTY TECHNICAL SCHOOL — Fairless Hills, PA
• Major in Industrial Chemistry
• Technical Degree — Equivalent to an Associates Degree
• Analytical chemistry, gas chromatography, organic and inorganic chemistry,
• Spectrometry, plastics technology.
• Medical Billing Course- Princeton, New Jersey
Clinical Supplies Course- 1/31/2008
Adaptive Clinical Trials
Basic Clinical Trial Course 3/18-3/20/08
PERI Course 6/08
PROFESSIONAL EXPERIENCE
Global Student Services of America LLC. 2010- present Data Analyst
• Update client databases.
• Trained and mentored new personnel in a fast-paced setting.
• Expedited purchase orders, data entry
• Updated information in SAP.
Global Language Service Networks Inc. 2010- 2015
• Executive Director
• Managed schools, employees, contractors
• Liaison with countries around the world
• managed financials
Aerotek Inc- Plainsboro, NJ 07/09 to 2010
Contracted at Bristol-Myers Squibb
• Process contracts
• Update databases
• Track enrollment
• Place drug orders
• Keep all regulatory documents up to date.
• Maintain Clinical Trial Spreadsheets.
• Maintain Clinical Studies from start to finish that were assigned to me.
• Attend country head meetings with the clinical team.
• Liaison with clinical team.
Research Pharmaceutical Services- Fort Washington, Pa 5/08 to 9/08 Research Pharmaceutical Services- Contracted in Merck
• Placed drug supply orders into the SAP System for domestic and international shipments.
• Provided Regulatory Approval for international countries around the world.
• Inventory management & Data Management in the MRP/ERP System.
• Created Stock Transfer Orders in JDE/ERP System.
• Lainson with Clinical Supplies Program Managers Daily on current needs.
• Resolved customer service issues domestically and internationally.
• Responsible for all customer service issues internally.
• Assessing/ evaluating patient enrollment data in the CTMS System.
• Tracked enrollment in CTMS.
• Responsibility for the planning, packaging, and distribution of drug supplies in JDE/ERP.
• Monitors all data in CTMS on sites coming on board.
• Maintained clinical trial spreadsheets for all protocols assigned.
• Prepared Documents for Regulatory Approval.
• Maintained confidentiality at all times.
• Verified pricing and shipping dates.
• Provided shipping documentation domestically and internationally.
• Coordinated all drug shipment orders domestically and internationally.
• Reacts well under pressure when emergencies arise.
• Checked for updates in the WRC System.
• Responsible for Drug Distribution worldwide.
• Updated information in the ERP/JDE Edwards System Aerotek- Lawrenceville, NJ 04/07 to 5/08
Drug Supply Coordinator- Contracted at Bristol-Myers Squibb in Lawrenceville, NJ
• Set- up the IVRS System from the beginning of a study then maintained it.
• Responsible for all drug distribution worldwide domestically and internationally.
• Responsible for all drug shipment issues domestically and internationally.
• Placed domestic and international orders in the SAP system.
• Inventory and order management of clinical supplies worldwide.
• Maintains clinical supplies tracking for all protocols assigned.
• Principle liaison for CSO, Clinical, and Regulatory Departments.
• Was responsible for getting the Green Light Approval to ship drugs to the sites worldwide. Notified all parties when the Green Light was obtained.
• Provided customer service updates to all personnel on drug shipments domestically and internationally.
• Responsible for getting import and export waivers for international shipments.
• Provided packing lists when requested domestically and internationally.
• Made sure all documents are in place for drug shipments. RHO CONSULTING INC. — Hillsborough, Pa 05/06 to 02/07 Database Analyst- Wyeth Pharmaceuticals in Collegeville, Pa.
• Worked with all Pharma, Biotech, Nutritional and CHC manufacturing sites in all regions.
• Verified supplier and material data in the Supplier Management System (SMS).
• Resolved all customer service issues domestically and internationally related to updates provided by suppliers.
• Provided customer service training to internationals.
• Ran international meetings weekly to provide updates.
• Worked on a Validation Project which included Phase 1 & Phase 2.
• Submitted web-based surveys to verify supplier/material Information collected by suppliers.
• Reviewed returned surveys and followed up with suppliers.
• Summarized discrepancies and communicated them to sites.
• Upon written site confirmation, entered data into SMS.
• Maintained supportive documentation.
• Updated information in SAP.
• Tracked supplier information.
ACCULOGIX INC. — Bristol, PA, 05/04 to 02/06
Returns Technician
• Inspected, audited, and received controlled and non-controlled drugs.
• Provide customer service and interacted with Project Managers and Supervisors on a consistent basis.
• Worked with project managers to resolve all drug shipment issues domestically and internationally.
• Support administrative and technical initiatives.
• Update client databases.
• Trained and mentored new personnel in a fast-paced setting.
• Successfully established a new department.
• Took a lead role in daily operations.
• Partnered with Information Technology staff members to
• Debug the computer system; upgrade the department to a new version of software.
• Worked with management teams to introduce newly approved
• Protocols.
• Managed and processed protocols for such clients as:
• Shire, Scios, Sanofi Aventis, Purdue, Bristol Myers Squibb, Celgene, and Covance.
• Worked in CTMS database system.
• Created incident reports and implemented corrective actions.
• Data Management in Lotus Notes System.
NYLOMATIC, INC. — Fallsington, PA, 02/95 to 11/98
Administrator/ Purchasing
• Expertly managed diversified administrative and Customer-related tasks to support well-executed operations.
• Inventory management, order management, material control, and Contract Negotiations, purchasing.
• Resolved all customer service issues related to material release dates,
• Initiated and developed relationships with customers.
• Implemented accurate data entry processes.
• Maintained MSDS documentation.
• Scheduled production.
• Collaborated in the development and testing of a new scheduling program that was customized to meet plant needs.
• Expedited purchase orders, data entry.