Laura Tarrant

acdl3s@r.postjobfree.com

908-***-****

Pharmaceutical compliance and technical complaint professional with

excellent communication and meeting facilitation skills, translating

strategy into actionable process. Consistently recognized by colleagues and

management for excellence in leadership, process understanding, and cross-

divisional collaboration leading to superior process outcomes and

departmental performance. Areas of expertise:

. detailed understanding of regulatory environment

. quality assurance assessment/KPI/metric development and analysis

. call center management . project management

. Adverse experience (AE) & Product Quality Complaint (PQC)

management

MERCK, Whitehouse Station, NJ

Contact Center Capabilities -

Quality Assurance & Compliance Project Manager

2012-

2013

Develop compliance framework and provide guidance to global contact center

developers/leaders in alignment with Merck strategies. Ensure each new

installation's compliance with Adverse Experience (AE), Product Quality

Complaint (PQC), Privacy and quality assurance requirements and other key

internal policies.

Create Standard Operating Procedure templates for management AE & PQC,

quality assessment process, privacy, audit management and training

activities.

Develop cross-functional metric roll-up process ensuring accurate and

complete statistics cross-divisionally.

2011-2012

AE/PQC Merck lead for US call center operations, ensuring regulatory

compliance, customer engagement and satisfaction levels were met.

Liaise with Merck's external call center vendor management, and internal

Quality, Medical Affairs, Pharmacovigilance and Legal. Call center

generated data consistently met all requirements and reduced compliance

risk as evidenced through quality assessment monitoring process.

Coordinated creation & approval of AE/PQC data collection tools utilized by

call center staff; ensured call efficiency/customer satisfaction and

actionable data for down stream partners.

Developed outbound customer letter and email standards, allowing consistent

output and optimization/strategic utilization of the contact center non-

phone activities.

Subject matter participant for FDA, EMEA, MHRA and internal compliance

unit audits. Developed an audit preparedness process for contact center

operations ensuring staff, operational and document readiness before and

during audit.

Partnered with strategic vendors/new business partners to create

management of AE/PQCs that met contractual and compliance requirements

and eliminated redundancies.

Laura Tarrant Page 2-908-***-**** acdl3s@r.postjobfree.com

Designed and implemented training modules for SOPs and job-specific

training which resulted in subject matter experts at the call center.

MERCK/Schering-Plough Corporation, Springfield, NJ

Global Medical Information - Senior Manager, Customer Quality Contact

Service 2000-2011

Merck/Schering-Plough PQC Intake Integration project lead, creating new

model impacting process, SOPs, computer system enhancement, staffing and

training, quality assurance monitoring. This integration milestone launched

successfully and on schedule.

Manage legacy Schering-Plough compliance-based customer contact group,

designated as the single point of contact for all US prescription and

medical device product quality complaints (PQC). Complaints received via

company 1-800 number and written format.

Manage 8 professional and 1 support staff

Time manage staff operations to successfully meet demands of department 1-

800 number

Develop and conduct PQC training for department including medical

professionals

Assess data and personnel compliance with local and corporate SOPs,

cGMPs and initiate corrective and preventative actions as needed

Create, analyze and report PQC KPIs and metrics

Author local SOP and Work Instructions - recognized as 'gold standard' for

rest of world

Develop Q&A/statements for media noted events ensuring appropriate

complaint management.

Contract reviewer for new business, ensuring inclusion of appropriate

compliance processes

Liaise with internal partner departments ensuring integrated cross-

divisional processes

Create Product Complaint Intake Standard deployed globally.

Integration leader for product quality complaint process and personnel

acquisition of Organon BioScience prescription and medical device products.

Process development with joint venture and third party

partners/manufacturers for complaint intake and recall activities

successfully meeting changing business needs.

Subject matter expert auditee for FDA, EMEA, MHRA and internal compliance

unit audits

Computer System: Analyze and develop computer enhancements for Title 21 CFR

part 11 requirements; system remediation/validation and version update

release; create user requirement documents, verify test outcome results,

update user manual

Laura Tarrant Page 3-908-***-**** acdl3s@r.postjobfree.com

Schering-Plough Corporation, Kenilworth, NJ

Drug Information Services - Senior Consumer Relations Specialist

1994-2000

Designated point of contact via 1-800 number and written communications for

medical professionals, consumers and company personnel for recording and

resolving product quality and user error complaints.

Triage complaint data to investigating departments.

Authorize replacement refund and/or return of product for physicians,

pharmacists and consumers.

Train new employees, including medical professionals on product quality

issues and handling.

Other Experience

Accountancy

Congoleum Corporation, Kearny, NJ

Supervisor, Accounts Payable, Accounts Receivable

Manage function and accuracy of output of the Accounts Payable and

Receivable Departments; supervised staff of 10. Prepared financial

analysis.

Implement online Accounts Payable computer system, system and report

development, staff training, liaison between computer department and senior

accounting personnel, verified accuracy and integrity of on-line testing.

Supervisor, Billing Department

Manage billing function and staff of 12. Tracked sales promotions,

including expenses and revenues generated. Improved departmental operating

procedures in response to sales programming and marketplace needs.

Eliminate unauthorized customer deductions

Staff Accountant

Record cash receipts and inter-company account entries; financial

analysis; banking reconciliations; calculate distributor bonus awards

program.

Education

Montclair State University, B.S. Accounting, Montclair, NJ

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