Senior Manager, Compliance Monitoring and Auditing

JEANETTE ARENDAIN

Perth Amboy, NJ / 732-***-**** / acze3p@r.postjobfree.com /

www.linkedin.com/in/jeanettearendain

PERSONAL PROFILE

Accomplished compliance and QA senior-level manager with expertise in driving business- process improvements through successful monitoring and audit programs. Extensive experience in team development and leadership, sales operations/management, project management, vendor management, and development/implementation of processes, standards, and systems in a wide range of organizations. Strengths include strategic thinking, problem solving and decision making skills.

CORE SKILLS AND EXPERTISE

Quality Assurance

Management

Internal/External Audit

Organizational Change

Leadership

Vendor Management

Compliance Monitoring System Administration Risk Management

Report & Document

Preparation

SOP/Process Development

Budget & Financial

Management

Regulatory Compliance

Continuous

Improvement

Root/Cause Analysis

PROFESSIONAL EXPERIENCE

Sr. Manager, Compliance Operations, Customer Event & Engagement 2015 - 2017 PFIZER INC, 235 E. 42nd Street, New York, NY 10017

Designed and executed monitoring programs and healthcare compliance self-audits to evaluate adherence to company policies, guidance and laws (i.e., FDA rules and regulations, OIG Guidelines, PhRMA Code, Anti-Kickback Statute, the False Claims Act, State Laws, Sunshine Act, Disclosure/Transparency Reports, CIA requirements, Adverse Events process, Sarbanes Oxley).

Expedited delivery of documentation requirements at litigation, depositions and case hearings involving speaker programs using Business Objects and pre-archived data.

Administered vendor data feeds and reports for HCP screening, State Law monitoring, Sunshine Act deliverables, and HCP Disclosure requirements.

Partnered with Compliance Team and Legal Counsels to re-evaluate various processes including enhancements to reporting and remediation on program and speaker violations in adherence to company policies, laws, and guidance. Sr. Manager, Compliance and Reporting, Speaker Operations Team 2006 - 2015 PFIZER INC, 235 E. 42nd Street, New York, NY 10017

Organized Corporate Audit requirements on system/process audits (with highest “Good” ratings) and IRO/CIA-related government audits (“No Findings”).

Formalized quarterly reports to Corporate Compliance on Speaker Program Live Audits for various CIA monitoring report requirements.

Global audit experience, focused on FCPA/GPIHP; Contributed to developing global monitoring programs.

Developed SOPs, job aids, process flows, and training materials for speaker programs based on system processes, corporate policies and government regulations. Jeanette Arendain 732-***-**** Page Two

Manager 2, Speaker Program Management, US Pharmaceutical Group 2005 - 2006 PFIZER INC, 235 E. 42nd Street, New York, NY 10017

Supervised logistics, system, and audit vendors such as Cardinal Health System (logistics vendor), Applied Info Partners (system vendor), and Ernst & Young (live audit vendor). Facilitated vendor contract management including SEA on various initiatives.

Coordinated system administration and data management for speaker programs and budget tracking system. Provided live system /process training to end users (e.g., Sales Phase 4 training; regional office sites).

Enabled relationship with Business Units, particularly for complex brand initiatives, speaker/program compliance matters, and resolutions. Manager 2, Regional Offices Operations (HQ Based) 2003 – 2005 PFIZER INC, 235 E. 42nd Street, New York, NY 10017

Aligned overall facilities and financial operations, resources, expansions/buildouts, lease and service contracts of the eight Pfizer regional offices (Parsippany NJ, Reston VA, Atlanta GA, West Lake TX, Chicago IL, Denver CO).

Built career ladders and capability continuum for administrative staff; mentored and trained staff on various leadership and management courses.

Managed $10M annual budget of eight Pfizer regional offices. Developed and implemented SOP’s and policies for all eight offices; ensured operations compliance and security monitoring of 8 regional offices.

Orchestrated various merger and integration activities on facilities and operations (e.g., Shut down of six Pharmacia business centers), in coordination with Human Resources, Finance, Legal, and Sales Operations.

Manager 1, Speaker Program and Management 2001 – 2003 PFIZER INC, 235 E. 42nd Street, New York, NY 10017

Administered budget system on tracking speaker programs; analyzed and generated budget and program reports for Sales VPs.

Developed training materials; trained and provided support to internal customers and speakers/HCPs; coordinated upgrades and training for Help Desk on new system changes.

Facilitated live training and guidance to the sales force, including Puerto Rico business units, for promotional compliance issues/questions; aligned with Legal and Corporate Audit to complete system updates on compliance materials.

Mid-Atlantic Regional Administrator/Sales Office Operations Manager 1997 - 2001 PFIZER INC, Reston Town Center, 11921 Freedom Drive, Reston VA 20190

Oversaw all regional office operations and supervised 3 direct reports and 36 support staff; accountable for annual regional operations budget: $1,500,000.

Administered regional accounts payable processes and other financial systems, office and training facilities and equipment.

Orchestrated regional events planning: annual company outing, regional dinners and anniversaries, United Way events, charity and volunteer events. EDUCATION HISTORY

University of San Carlos, Cebu, Philippines

Graduated 1983

Bachelor of Science in Business Management, Cum Laude

(Evaluated and certified U.S. Accredited Degree)

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