Healthcare Compliance Due Diligence

Contact

***********@*****.***

www.linkedin.com/in/kristyotterbein

(LinkedIn)

Top Skills

Coupa Risk Assess

Third Party Risk Management

(TPRM)

Due Diligence

Languages

English

Certifications

Healthcare Compliance Certification

- US Program

Training Generalist

Applied Learning and Creative

Teaching Certificate

Healthcare Compliance Certification

- European Program

Managing the Training Function

Certificate Program

Kristy Otterbein

Global Pharmaceutical Compliance Professional Independent Consultant

Greater Tampa Bay Area

Summary

Certified in both US and European Healthcare Compliance, I bring 30 years of pharmaceutical industry experience with a proven track record of upholding ethical standards and driving compliance excellence. My expertise spans Compliance Operations, strategic project and program management, and deep regulatory knowledge. I have hands-on experience with FDA regulations, OIG guidance, and global industry codes including PhRMA, IFPMA, EFPIA, and various country-specific standards. Currently, I focus on third- party due diligence, helping organizations navigate evolving legal requirements and mitigate risk with integrity and foresight. Passionate about building compliant, ethical frameworks that support sustainable business growth.

Experience

Self-Employed

Independent Pharmaceutical Compliance Consultant

April 2016 - Present (9 years 2 months)

Chicago/Tampa/Global

As a seasoned Global Pharmaceutical Compliance Operations Consultant, I am known for combining a strong ethical foundation with a practical, results- driven mindset. I lead with integrity, ensuring compliance is not only met but embedded into the culture of the organizations I support. With deep experience in cross-functional leadership and a global perspective, I’ve successfully built and executed compliance programs that align with complex regulatory frameworks. My focus areas include healthcare compliance operations, Anti-Bribery/Anti-Corruption (ABAC) initiatives, third- party due diligence, and cross-border HCP/HCO engagement oversight. Highlights:

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Proven track record of leading global compliance initiatives across diverse teams and geographies.

Architect of comprehensive compliance systems—from policy and training to monitoring and corrective action.

Expertise in navigating regulatory challenges and fostering collaboration between legal, compliance, and business functions. I take pride in transforming compliance into a strategic asset—ensuring organizations are not just protected, but empowered to grow responsibly in a highly regulated industry.

Takeda Pharmaceuticals

11 years 10 months

Global Compliance Training and Communications Manager April 2015 - April 2016 (1 year 1 month)

Implement Training & Communication programs for Takeda employees consistent with OIG regulatory guidance, IFPMA Code requirements and other applicable codes, laws, regulations and internal policies and procedures by executing the following duties and responsibilities:

• Develop and implement company-wide training program and strategies (e.g., Takeda’s Code of Conduct and Compliance Policies for Interactions with Healthcare Professionals) and yearly training plans.

• Facilitate cross functional team meetings on a project-by-project basis.

• Collaborate with Global Compliance colleagues to develop and implement training courses to address HotLine/HelpLine issues, audit results and/or investigation matters.

• Provide on-site support to respond to inquiries received via Takeda’s Helpline or through other reporting mechanisms as needed.

• Manage and build a collaborative network of relationships with other functional areas to identify areas of risk or knowledge deficiencies and work with them in designing and implementing new hire, function-specific, and remedial training.

• Develop and administer training using a variety of instructional techniques and formats (e.g., e-learning courses, teleconference/WebEx trainings, PowerPoint presentations).

• Manage training material development, production, distribution and inventory. Page 2 of 5

• Develop and implement a Compliance Communication Program and annual plan.

• Manage the development and deployment of a Compliance Awareness Assessment.

• Manage the content, logistics, and execution of a various Compliance-related communication initiatives.

• Support other compliance teams on an as needed basis for either project- based or operational activities that pertain to broader compliance initiatives.

• Review training materials for other functional areas for compliance with internal/external policy, law and regulation requirements. Compliance Training & Communications Program Manager September 2008 - March 2015 (6 years 7 months)

• Develop and implement company-wide training and communication programs and strategies (e.g., Takeda’s Code of Conduct and Compliance Policies) and yearly training and communication plan.

• Manage the annual analysis, review/update, socialization and deployment of Takeda’s Code of Conduct and Compliance Policies training.

• Facilitate cross functional team meetings on a project-by-project basis.

• Collaborate with OEC members to ensure that HotLine/Helpline issues, audit results and/or investigation matters requiring training are developed and implemented.

• Manage and build a collaborative network of relationships with other functional areas to identify areas of risk or knowledge deficiencies and work with them in designing and implementing new hire, function-specific, and redial training.

• Manage the OEC training system. This includes assigning, monitoring and tracking course completions. Establish and maintain databases and training activity records compliant with Takeda’s record retention requirement. Identify and analyze trends, produce statistical reports and make presentations to the senior management.

• Manage the entire relationship with third-party vendors. This includes selection, project planning, proposals, timelines, contracts, budgets, and quality of work produced by internal and external resources.

• Manage the development and deployment of Compliance Awareness Assessment.

• Manage the content, logistics, and execution of various OEC communication initiatives (e.g. OEC Compliance Awareness Events for home office or field).

• Support other compliance teams on an as needed basis for either project- based or operational activities that pertain to broader compliance initiatives. Page 3 of 5

• Review training materials for other functional area for compliance with internal/external policy, law and regulatory requirements.

• Membership and participation in Takeda Learning Consortium (Community of Practice) and subcommittees.

Quality Assurance Documentation and Training Specialist July 2004 - September 2008 (4 years 3 months)

• Develop, execute, and implement training strategy for assigned functional areas.

• Lead specific teams to design, develop, implement, and maintain various training initiatives, programs, and curriculums required.

• Developed and delivered monthly Introduction to Good Clinical Practices

(GCP) training to new employees.

• Lead and facilitate meetings with SMEs from functional area teams to develop process maps, as well as create and revise procedure documents.

• Collaborate with SMEs to design, develop, implement, and deliver training based on creation and revision of procedure documents.

• Evaluate the effectiveness of training programs, methodologies, options, and the selection of the appropriate mix for each specific functional area.

• Identify appropriate training vendors, negotiate contracts.

• Evaluate internal processes, suggest process improvements, design/ implement quality improvements, and create appropriate documentation. TAP Pharmaceutical Products, Inc.

11 years 5 months

GxP Training Specialist

August 1999 - July 2004 (5 years)

• Develops, coordinates, and presents training and development programs, including conducting needs analyses, establishing training requirements, developing training resources and evaluating professional, scientific and GXP training programs.

• Maintains and updates QA departmental PPG (Policies, Procedures, Guidelines, and Work Instructions) Training Matrix.

• Generates monthly PPG compliance report for managers.

• Identifies and prioritizes current training needs and new GXP training initiatives for QA department personnel.

• Assists in the design or revision of new and existing courses.

• Coordinates the use of outside facilities for training presentations. Negotiates contracts and maintains accurate records of all financial expenditures.

• Maintains training enrollment, registration, and attendance records. Page 4 of 5

• Performs periodic audits of employee training files and training procedures to ensure GXP and PPG departmental compliance.

Associate Clinical Studies Specialist

July 1998 - August 1999 (1 year 2 months)

• Logged and tracked patient case report forms and addenda/queries

• Logged and prepared critical documents for submission to Regulatory Affairs and RIC (archive)

• Organized and proof study summaries/reports for submission to Regulatory Affairs and RIC

• Maintained and created study satellite files and investigator database Senior Administrative Assistant

March 1993 - July 1998 (5 years 5 months)

• Provided support for Clinical Research Managers and Clinical Research Associates with clinical studies by maintaining study files, processing regulatory documents, sending drug supplies to doctors and working with vendors

• Created and maintained investigator database

• Processed patient case report forms for various TAP studies

• Entered financial data for R&D budget records

• Prepared and checked expense reports for accuracy

• Other administrative duties

Education

National Louis University

BS Health Care Leadership, Healthcare Management and Leadership Compliance Conferences

General Conferences

Training Certifications

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