The purpose of this position is to help establish and implement the R&D Compliance Monitoring and Analytics Program for Takeda. This position will assist with ensuring that:
risk areas are identified and routinely monitored,
Takeda has policies and procedures covering identified risk areas,
the appropriate policies and procedures are implemented and communicated and
Takeda’s policies and procedures are being followed.
This position will help the Office of Ethics & Compliance (OEC) establish a Compliance Monitoring Program for the R&D business that is consistent with OIG guidance and develop plans that monitor adherence with ACCME, PhRMA Code, IFPMA Code, AMA guidelines, Compliance Guidelines, the Code of Conduct, Nevada statute AB128, and other applicable laws, regulations and internal policies by monitoring adherence with applicable laws and internal policies by:
Monitoring and Analytics:
Assist with developing, drafting and employing general policies, procedures and processes to establish the R&D Compliance Monitoring Program;
Identify and monitor areas of risk to Takeda through formal and informal risk assessments and gap analyses;
Create a commercial monitoring program that incorporates OIG guidance, aligns with past and planned business activities, is consistent with the industry and fits within the Takeda culture
Communicate and assist with the implementation of the monitoring plan and system to assess the controls in place that mitigate identified risks to Takeda;
Communicate, prioritize and manage action plans resulting from monitoring findings and recommendations; ensure that all significant areas are appropriately documented and addressed;
Assist business groups with understanding, processing, and implementing corrective action plans that address monitoring findings or other audit finding
Manage monitoring files and records, ensuring files are in accordance with Record Retention schedules
Conduct research, attend industry conferences, consult with industry counterparts and audit experts to continuously build upon the R&D compliance strategy
Assist the OEC in other tasks, as assigned, that are relevant to compliance program management;
Develop a data analytics strategy and portfolio of leading indicators that can be used by the R&D Compliance group to monitor business activities
Create reports that can be utilized with the R&D Compliance team to document and review analysis results. Also, ensure that there are sufficient reports to share at an executive level.
Support other compliance teams on an as needed basis for either project-based or operational activities that pertain to the commercial function or other broader compliance initiatives.
Build networks and relationships with other functional areas to build support for the monitoring plans and initiatives
Help to educate Takeda personnel on applicable policies Qualifications EDUCATION, EXPERIENCE AND SKILLS:
Minimum two years general business experience
Ability to process and analyze information and develop related action plans
Ability to perform duties and tasks necessary to manage multiple projects.
Compliance monitoring experience
Knowledge of R&D specific compliance issues
Knowledge of current compliance issues facing the pharmaceutical industry in general, including fraud and abuse issues resulting from interactions with healthcare professionals and reimbursement by government payment program.
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. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Ability to drive or fly to various meetings/client sites.
Moderate travel, approximately 35-40% of total work time.
We are driven to improve people's lives.
We are an equal opportunity employer.
No Phone Calls or Recruiters Please.