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Associate Director, Compliance Monitoring and Risk Assessment

Job Description

Join a Legacy of Innovation 110 Years and Counting!

Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 16,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. Under the Group's 2025 Vision to become a "Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.


This role is responsible for the development and implementation of the Compliance Risk Assessment that informs many facets of the Compliance program (e.g., monitoring plan and Compliance audit plan). This role will partner with members of the Compliance team on critical projects and provide project management support; is responsible for the development and implementation of the data analysis and reporting capabilities that support Compliance Monitoring (CM) risk assessment, field monitoring, and continuous monitoring activities included in the Monitoring Plan. This role will be responsible for maintaining current monitoring activities and working with internal stakeholders, including IT, to create new monitoring tools, improve our data analysis capabilities, and improve departmental efficiencies through analytical approaches (e.g., identification of outliers to focus monitoring/audit activities). This position will also be responsible for completing Compliance audits throughout the organization.


- PROJECT MANAGEMENT: Participate in compliance-driven company-wide initiatives and special projects as determined by the group leader.
- Provide IT liaison and systems support to the Company's Data Privacy Program, managed within the Compliance Department
- Provide project management support to the Compliance Department to help deliver key systems utilized by the department
- Serve as IT liaison for the Compliance department
- Role includes Systems administrator responsibilities
- DATA ANALYTICS: Serve as internal data expert on designing and extracting data from various internal systems that meet the requirements of the Monitoring Plan. Activities may include but are not limited to:
- Designing specific monitoring methodology
- Determining appropriate data sources for individual monitoring activities
- Validating accuracy and completeness of data
- Recommending data required to meet process and control requirements for business-led monitoring
- Develop and maintain key metrics reports for the Compliance Monitoring group for distribution to Compliance and Audit Committees
- COMPLIANCE AUDITS: Assist the group leader in the planning, organizing and executing of compliance audits to mitigate risks identified by the annual compliance risk-assessment.
- RISK ASSESSMENT: Develop and implement the annual Compliance Risk Assessment to inform the Compliance Program. Partner with various members of the Compliance group to ensure the risk assessment addresses key risks within their function.
- COMPLIANCE MONITORING: Develop and implement monitoring tools/reports, field monitoring and analytics to support overall monitoring strategies (e.g., termination monitoring). Assess current and identify additional monitoring tools that may fill any gaps to assist Compliance Monitoring.

Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.

Education Qualifications (from an accredited college or university)

- Bachelor's Degree preferably in quantitative discipline or related field required

Experience Qualifications

- 7 or More Years Pharmaceutical industry or equivalent industry required
- 4 or More Years Data Analysis roles required
- Demonstrated project management skills and leadership required
- Strong system knowledge of the communication tools used by the company (i.e., Email, Field Coaching Reports, OneNote, Performance Management Excellence, Insight, etc.) required
- Experience working in an audit or monitoring group or pharmaceutical sales preferred
- Proficient in MS Office Suite of programs; specific experience using Excel (e.g., pivot tables, graphing, macros, etc.) preferred
- Strong knowledge of Automated Control Language (ACL), IDEA data analysis software and/or SAP preferred
- Strong ability to ID critical systems related to the engagement of and payments to HCPs/HCOs and the provision of grants and charitable contributions preferred


Ability to travel up to 10% Field Monitoring requires travel within the U.S.

Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.

Associate Director, Compliance Monitoring and Risk Assessment

Bernards, NJ
Full Time

Published on 05/26/2023

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