Implements the Health Care Compliance (HCC) program locally under supervision of the Senior HCC Manager, SOP management, Activity Management System maintenance, HCC related process optimization of Xian Janssen Pharmaceutical Ltd. (Xian Janssen) to ensure business practices and activities of Core Product Division (CPD) are in compliance with related J&J internal guidelines, local laws and regulations and anti-corruption laws including the Foreign Corrupt Practices Act (FCPA); and serves as a strategic business partner for CPD and coach towards all covered employees, to assure that the company culture of compliance is a natural element in day to day business.
ESSENTIAL DUTIES AND RESPONSIBILITIES
· The HCC Manager will ensure that the HCC program effectively prevents and/or detects violations of law, regulations and/or policies in PSY part of CPD business units (BUs):
o Partner with the leadership team to ensure compliance ownership and right tone at the top.
o Support ethical decision-making capability within the business by participating in leadership team meetings, reviewing promotional strategies and other significant business initiatives from the HCC standpoint.
o Ensure business activities with health care professionals (HCPs)/government officials (GOs) are planned in consistence with applicable HCC policies and procedures by reviewing and pre-approving those activities.
o Act as a consultant to provide day-to-day guidance, advice to covered employees.
o Deploy HCC policies and/or procedures in covered BUs by providing necessary training and/or communication to covered employees, managing changes, and monitoring implementation.
o Tailor HCC training materials to fit into the needs and business context of covered BUs and deliver frequent trainings to covered employees at various levels such as leadership team, regional level, and/or territory level.
o Participate in company HCC monitoring program to identify warning signals and/or gaps and provide meaningful feedback and insights to leadership team so that appropriate corrective actions are taken.
o Stimulate and contribute to innovative approaches towards HCP's and GOs consistent with the HCC/HCBI guidelines and framework.
- Lead MAP process and track MAP status with all stakeholders to ensure the timely implementation of the actions, conduct review on MAP implementation to ensure the control effectiveness, take remediation action to address any deviation.
o Manage and monitor execution of established MAPs in a timely manner.
o Ensure HighBond (HCC MAP management system) accurately reflects the remediation plans, current MAP status, root cause analysis, and all required data fields are complete and updated per the published due dates.
o Maintain documentation to support appropriate closure of MAPs, including optimizing HighBond as a repository and system of record, as appropriate.
o Communicate MAP status to the management on a timely basis.
o Facilitate MAP effectiveness review process with the regional testing and audit team.
- Lead risk assessment project to ensure that the process and output are used to shape compliance program(s) within our scope of responsibility including specific mitigation plans based on prioritized risks.
o Design plan for Annual Risk Assessment Project based on the requirements from regional and local business status.
o Set up and integrate risk assessment feedbacks from stakeholders for the internal environment and business capability scans which covers potential risks identified, how to mitigate risks and action plans.
o Develop heat map to show potential compliance risks visually.
o Establish mitigation plans based on the overall review for every specified risk.
- Deliver HCC annual certification from status of compliance program, accomplishments, challenges and next steps.
- Lead and maintain HCP and Speaker Management to ensure all HCPs are qualified, streamline and simplify the speaker management process.
- Interface with legal counsel regarding HCC requirements and interpretation.
- Interface with the global/regional HCC community to share approaches to HCC.
EDUCATION & EXPERIENCE:
· BA/BS, advanced degree or equivalent preferred
· Minimum of 5 years business experience
· Knowledge about FCPA and related local laws and regulations preferred
SKILLS and ABILITIES:
· Demonstrate strong organizational, interpersonal and communication skills
· Breadth of experience in all areas of:
o Compliance and regulation
o Devising and implementing SOPs
o Testing and monitoring
· Independent and objective thinker, able to advance ideas and influence others
· Manages conflicts in an open and constructive manner
· Excels at developing and maintaining effective partnerships and working relationships with key stakeholders at all levels of organization based on an understanding of their concerns, needs and motivations.
· Strong drive for results and solution orientated
· Fluent in English (reading, writing, verbal)
· High level of integrity with good ethical core values
· Ability to make and stand by difficult decisions
· Good interpersonal skills
Xian-Janssen Pharmaceutical Ltd. (7043)