Compliance Specialist

Kyowa Kirin is a fast growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four areas of unmet need: oncology, nephrology, immunology and CNS/movement disorders. The North America organization includes three offices (in New Jersey and California) that focus on drug discovery, product development, and commercialization. Together, we work as a close-knit team to understand clinical needs and advance innovations that can have a profound impact on patient lives.

*Please note this is not a fully remote opportunity. Employee will be expected to work a hybrid schedule being in the office twice a week. 

Summary of Job:

The Compliance Specialist will be a key team member supporting day-to-day Compliance tactical and operational activities, a critical component to supporting the company’s rapid business growth in North America.  The Compliance Specialist will be responsible for helping to drive a culture of compliance and ensuring that our business operates ethically and in line with our global corporate values: Commitment to Life; Innovation; Integrity; and Teamwork/WA. The Compliance Specialist will support the Compliance organization in identifying, preventing, and correcting noncompliance by employees, contractors, and business partners. The successful Compliance Manager will execute components of the compliance program and program improvement initiatives.  Additionally, the Compliance Specialist will foster compliance across the company with state and federal laws, regulations, and industry codes, as well as Kyowa Kirin company policies and procedures.

Essential Functions:

The Compliance Specialist is responsible for day-to-day implementation of the Compliance Program in accordance with, but not limited to, the below:

• Supporting a healthcare compliance monitoring and auditing program across Kyowa Kirin North America including Commercial, Medical Affairs, Patient Advocacy, Patient Services, R&D, etc.
  • Conducting desktop monitoring (e.g., review Expense Reports, Speaker Program Reports, Field Coaching Reports, Medical Insights, Medical Information Requests, Close Out Forms, State Meal Limits, etc.)
  • Coordinating with employees to remediate HCP related expense issues and escalating concerns for appropriate follow up and/or investigation
  • Developing standard reports to summarize remediation and desktop monitoring findings
  • Conducting live monitoring, as needed (e.g., Ride-Alongs, conferences, speaker programs, advisory board meetings, patient advocacy events, sponsorships, etc).
  • Updating and maintaining monitoring forms and dashboards, as necessary
• Supporting the management of sample accountability including PDMA training, storage and reporting requirements,
• Supporting the development of materials for internal trainings, monthly meetings and committee meetings, as needed
• Tracking and maintaining training content and associated training records
• Supporting state and federal transparency reporting across the region including: remediation of data entries, matching data, assisting with the monitoring and submission of state reports, as needed
• Maintaining the department policy tracker, running reports on documents and associated training records
• Supporting the evolution of Compliance policies and procedures
• Managing contracts and associated purchase orders for the Compliance department
• Maintaining and advancing templates

Job Requirements:

Education

Bachelor’s Degree

Experience

Two years or more of work experience in related field is preferable but not required. Business acumen, Experience with/Knowledge of data infrastructure; data analytics experience, preferred. Excellent oral and written skills. Self-motivated, independent and team player, with strong organization skills and ability to focus on details and results oriented. Ability to manage multiple assignments, projects, and vendors.

 Technical Skills

Proficient in MS Office Suite.

Non-Technical Skills

Demonstrated ability to organize, prioritize, meet deadlines, make decisions, and change course of action quickly. Strong interpersonal and communication skills. Strong work ethic is required. Detail oriented and excellent follow through. Has the ability to flex and deal with ambiguity in a dynamic, fast-paced, high growth environment. Has a passion for personal learning and development to be able to grow with the company. Cultural sensitivity and ability to develop consensus within a multinational organization.

Physical Demands: 

Normal office environment with prolonged sitting and extensive computer work

Working Conditions: 

Requires up to 15% domestic and international travel

KKNA and all of its employees have an obligation to act in accordance with the law and with integrity in all our operations and interactions

It is the policy of Kyowa Kirin North America, Inc. to provide equal employment opportunity to all qualified persons without regard to race, religion, creed, color, pregnancy, sex, age, national origin, disability, genetic trait or predisposition, veteran status, marital status, sexual orientation or affection preference or citizenship status or any other category protected by law.

When you apply to a job on this site, the personal data contained in your application will be collected and stored by Kyowa Kirin, Inc. (“Controller”), which is located at 135 Route 202/206, Suite 6, Bedminster, NJ 07921 USA and can be contacted by emailing [email protected]. Controller’s data protection officer can be contacted at [email protected]. Your personal data will be processed for the purposes of managing Controller’s recruitment related activities, which include setting up and conducting interviews and tests for applicants, evaluating and assessing the results thereto, and as is otherwise needed in the recruitment and hiring processes. Such processing is legally permissible under Art. 6(1)(f) of General Data Protection Regulation (EU) 2016/679 (“GDPR”) as necessary for the purposes of the legitimate interests pursued by the Controller, which are the solicitation, evaluation, and selection of applicants for employment. 

Your personal data will be shared with Greenhouse Software, Inc., a cloud services provider located in the United States of America and engaged by Controller to help manage its recruitment and hiring process on Controller’s behalf. Accordingly, if you are located outside of the United States, your personal data will be transferred to the United States once you submit it through this site. The transfer will be made using appropriate additional safeguards under the standard contractual clauses approved by regulators for transfers of personal data outside the European Union.

Your personal data will be retained by Controller as long as Controller determines it is necessary to evaluate your application for employment.  Under the GDPR, if you are located in the European Union, you have the right to request access to your personal data, to request that your personal data be rectified or erased, and to request that processing of your personal data be restricted. You also have the right to data portability, and to lodge a complaint with an EU supervisory authority. If you have any questions about our use of your data, you may contact us by email at [email protected].

Kyowa Kirin does not accept agency resumes unless contacted directly by internal Kyowa Kirin Talent Acquisition. Please do not forward resumes to Kyowa Kirin employees or any other company location; Kyowa Kirin is not responsible for any fees related to unsolicited resumes.

#LI-Hybrid

#LI-JC1