Development Specialist Compliance Manager

CASIE M. SUHR

Flemington, New Jersey ad2048@r.postjobfree.com 908-***-****

COMPLIANCE MANAGER TRAINING INNOVATION LEADERSHIP CORPORATE COMMUNICATIONS

Compliance Manager, Training & Development Specialist & Communications

Highly skilled, dynamic and creative compliance and training development specialist with 8+ years of comprehensive experience in building compliance programs, creating training content, corporate communications, and managing systems. Aptitude to succeed in a high paced, high volume industry - providing insight for complex decisions, managing product compliance & delivering training outcomes.

PROFESSIONAL EDUCATION & CREDENTIALS

GWYNEDD MERCY UNIVERSITY Gwynedd Valley, PA

Master of Business Administration – Strategic Management & Leadership (4.0) 2015 - 2017

STOCKTON UNIVERSITY Galloway, NJ

Bachelor of Arts – Criminal Justice (3.5 – Dean’s List) 2011 – 2014

PROFESSIONAL EXPERIENCE

Sr. Manager, Quality & Compliance, Global Medical Affairs, The Janssen Pharmaceutical Companies of Johnson & Johnson - Joule Raritan, NJ Feb 2023-Present

MAIN RESPONSIBILITIES

●Plan, develop and deploy a compliance program for the Global Medical Affairs Team.

●Accountable for the generation of deliverables providing visibility to compliance programs and systems within the Global Commercial Strategy Organization (GCSO).

●Develop and generate the Quality System Management Report (QSMR), training metrics reports, facilitates procedural document management, CAPA investigations and inspection/audit support for GCSO.

●Support the development of an efficient and effective compliance operating model with demonstrable adherence to defined standards.

●Work in connection with Global Teams including Market Access, Patient Services, Strategic Marketing and Patient Reported Outcomes.

PRIOR RELEVANT PROFESSIONAL EXPERIENCE

Sr. Analyst, Compliance Training & Communications Basking Ridge, NJ

Daiichi Sankyo Inc. Feb 2021-Feb 2023

MAIN RESPONSIBILITIES LEADERSHIP INITIATIVES

• Training • Analytics, Reporting & Communications

• Plan, create and develop training • Develop and execute communication plan for compliance topics

• Policy creation and review supporting teams annual and periodic training objectives

• Project Management • Develop, create and track reporting metrics for company and global trainings

Training: Plan, create, draft and deliver innovative training to inform and educate employees on compliance issues via the LMS, Articulate and Camtasia.

Learning Management System: Plan and execute the deployment and migration of global training for vendors from external to internal LMS.

Policy & Law: Assist with identification, creation and dissemination of Corporate Compliance policies. Assist with drafting non-GxP policies and review and renew existing policies and procedures. Understanding of compliance laws such as ABAC, Sunshine Act, Data Privacy Laws, PhRMA Code, and HIPPA.

Communications: Plan and publish communications via email and internal magazine publication spotlighting hot topics in compliance and at the company.

TECHNICAL, PROFESSIONAL & LEADERSHIP COMPETENCIES

TECHNICAL EXPERTISE

MARKETING/COMMUNICATION

TRAINING / LEADERSHIP

Microsoft OS - 365

WebEx / Skype Business / SharePoint

Articulate 360, Storyline, Rise

Photoshop / In Design

Microsoft Teams

Camtasia Video Training

Summit (Cornerstone), Xcelerate Media Learning Management Systems, Success Factors, & Compliance Wire

Adobe Acrobat X

Box Secure File Sharing/AirTable

Social Media (Facebook, Instagram, Yammer etc.)

Populo

AdobeConnect Conferencing

Blackboard Collaborate

Axonify (eLearning Software)

ADDITIONAL RELEVANT PROFESSIONAL EXPERIENCE

Sr. Training Specialist Ewing, NJ

GS1 US 2018-Feb 2021

MAIN RESPONSIBILITIES LEADERSHIP INITIATIVES

• System Administrator for Xcelerate Media LMS • Project Lead on conversion from traditional to virtual classroom

• Development/maintenance of content • Manage LMS for 18,000+ Users

• Asset Management • Lead eLearning Design Process

• Project Management • Provide and update metrics for OGSM data

Content Development: Developed content for the virtual classroom offering, which was expedited for the need of customers once COVID created a remote work environment. Project lead on U.S. FDA UDI online certificate course offering.

Learning Management System: Manage content library and organization structure, upload and categorize content, data preparation and run usage reports, conduct audit of current processes and procedures. Lead the migration and system updates to a new LMS which provided members with a more functional experience.

Media Development: Develop/update Adobe Captivate, PowerPoints, job aides, quizzes, and other training materials consistent with brand standards

Acclaim Badging: upload badge earner information, track badge expiration dates for pro-active certificate extension.

Hands-on-Training Classroom scheduling: Coordinate instructor/attendee logistics, order materials, room preparation, etc. Measure instructional effectiveness and generate summative evaluation reports with the goal of defining the impact of training. Schedule/track certificate training, run reports, maintain SharePoint site, schedule course delivery sessions, and material preparation

Content Management Specialist / Training Content Compliance Lead Somerville, NJ

Johnson & Johnson: Ethicon 2014 – 2018

MAIN RESPONSIBILITIES LEADERSHIP INITIATIVES

• Backup Administrator for Cornerstone LMS • Project Lead on Ethicon Academy Rebrand

• Lead All Training Curriculum Development • Manage Global Content Portal for 11,000+ Users Worldwide

• SharePoint Systems Administrator • Design, Create and Launch All Communication Portals

• Manage All Training Content • Track, Update and Ensure All Compliance Standards

TRAINING DEVELOPMENT / CONTENT CREATION / AUDIT COMPLIANCE / COMMUNICATION / MARKETING DESIGN STRATEGIC PROBLEM SOLVING / GLOBAL COORDINATION / INNOVATIVE TROUBLESHOOTING

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