Job Summary/Objective:
This position will assist with supporting and ensuring the effective management of Neurelis’ Compliance Program. This Compliance Analyst will utilize various software to conduct audit and remediation of HCP transaction data for transparency as well as audit of data submitted from various third-party vendors. Responsibilities will include helping to maintain monitoring goals and oversight of healthcare compliance policies, procedures, training, and controls. This position will require an individual who is comfortable working in a dynamic environment and has a pragmatic approach to identifying and managing risk.
Essential Job Functions:
Training:
- Enhance training curriculum for colleagues and third parties on compliance policies, including their practical application to the respective audience, including new hire onboarding.
- Retain and archive all training logs.
- Oversee training materials and training assignments, including monitoring of completeness.
- Along with other department personnel, create and implement effective training on areas that are discovered in the audit process that need to be remediated.
Policies/Communications:
- Contribute to Compliance work plan development and continuous improvement.
- Draft company-wide and region-specific communications/updates on healthcare compliance.
Sunshine/State Reporting:
- Assist in collecting, preparing, and remediating transparency data for Federal Sunshine Report and various State report submissions.
- In coordination with Commercial Operations, assist with management of field state reporting requirements such as registration and licensing requirements.
Monitoring, Auditing and Data Analytics:
- Assist as needed with conducting various field monitoring activities as part of Neurelis’ monitoring plan, including live program and field ride assessments to identify patterns signaling potential inappropriate healthcare professional interactions in the area of speaker programs, advisory boards, and sales representative customer interactions. This includes audit and monitoring of specialty teams, ie. MLSs, MDADs, and NADs.
- Manage monitoring logs and checklists.
- Assists in ad hoc projects related to general corporate compliance concerns and issues, including developing compliance required policies, documents, and training.
Competency (Knowledge, Skills, and Abilities):
- Knowledge or familiarity with pharmaceutical and/or device industry laws and regulations.
- Excellent oral and written communication skills.
- Strong analytical and critical thinking skills with attention to detail.
- Ability to prioritize, schedule and manage multiple projects.
- Ability to meet tight deadlines and manage expectations.
Personal Performance Factors:
- Demonstrates strong work ethic.
- Shows initiative and holds themselves accountable.
- Lives and advances the Neurelis culture and values.
- Always operates with a high degree of integrity and tact.
- Demonstrates sound judgment and decision-making ability.
Management Responsibilities and Skills:
Physical Demands and Work Environment:
Office Demands and Work Environment: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Spends approximately 90% of work time sitting and meeting with others or working at a desk and/or computer. Spends approximately 10% of work time standing or walking within the work area or at meetings and bends, twists, stoops and reaches. Ability to communicate verbally and in writing. Occasionally lifts and/or moves up to 10 pounds. Working conditions are normal for an office environment. The noise level is usually moderate.
Travel Requirements:
- Ability to travel up to 10%
- Overnight travel required? Yes
