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Senior Associate, Compliance Monitoring

3 months ago

Bernards Twp, United States Daiichi Sankyo Full time

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 120 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. In addition to a strong portfolio of medicines for cardiovascular diseases, 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.   

Summary

This role will support the leader in the development and implementation of the Compliance Monitoring Program, specifically Federal healthcare laws, FDA promotional guidelines, and all applicable laws, guidelines, and regulations. This individual will partner with members of the Compliance team on critical projects and provide support; 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).

Responsibilities

Compliance Monitoring

  • Responsible for activities related to developing, conducting, and reporting the Compliance Monitoring Plan (e.g., utilizing monitoring tools/reports, field monitoring and analytics).
  • Annually evaluate and revise the CM plan as necessary.
  •  Identify areas of potential non-compliance and assist in the remediation of risk,
  • Responsible for the selection of specific Employees, business events, and activities that are monitored.
  • Maintain prompt and accurate records and documentation related to all monitoring activities and results.
  • Conduct field-based (live) monitoring, records review, and data-based monitoring

Data analytics

  • Maintain/revise current monitoring tools/reports, as necessary, and develop new monitoring tools and analytics to support overall monitoring strategies (e.g., new metrics in the area of speaker programs, TE, TOV, Unsolicited off-label requests, etc.).
  • Assess current and identify additional monitoring tools that may fill any gaps to assist DSI in monitoring promotional, non-promotional and financial activities.

Communication

  • Ensure monitoring findings are discussed with Compliance leadership, assist in drafting email reminders, training bulletins, and relevant training module creation.
  • Work with the various business functions across the business to design and review business-led monitoring activities as part of their overall responsibilities and, if required, assist in developing reporting tools so that CM can receive monthly updates on the monitoring activities.

Project Management

  • Participate in company-wide initiative and special projects as assigned by the leader. Conduct special analyses on request.
  • Assist in ad hoc monitoring activities as required to ID appropriate systems, data sources, and reports that can aid in overall analysis to determine potential compliance issues.
  • Prepare annual reports that detail the progress and results of the CM Plan. Aid in the developments of materials for presentations at various senior level committee meetings (CECC, BOD).

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


Education (from an accredited college or university)
- Bachelor's Degree prefer degree in a quantitative discipline or equivalent work experience required

Experience
- 4 or More Years in a monitoring and/or data analysis type role required
- in the pharmaceutical industry required
- Prior experience working in monitoring group or pharmaceutical sales preferred
- Proficient in MS Office Suite of programs; specific experience using Excel (e.g., pivot tables, graphing, macros, etc.)
- Strong ability to ID critical systems related to the engagement of and payments to HCPs/HCOs and the provision of grants and charitable contributions
- Strong system knowledge of the communication tools used by the company (i.e., Email, Field Coaching Reports, OneNote, Performance Excellence, VEEVA, etc.)

Travel

Ability to travel up to 30% Field based (live) Monitoring and attendance at National Meetings 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.