HireDiversity

Beijing, CN

Sr. Health Care Compliance Manager, Pharm China,R&D & Scientific Affairs-000009F4

Description

SUMMARY:

Leads and drives the Implementation of the Health Care Compliance (HCC) program to ensure business practices and activities in R&D (including GCO, CDMA, RA and ME) and Scientific Affairs (Collectively R&D and SA) are in compliance with related J&J internal guidelines, local laws and regulations and anti corruption laws including the Foreign Corrupt Practices Act; Serves as a strategic business partner for R&D and SA management and coach towards all covered employees, to assure that the company culture of compliance is a natural element in day to day operation.

This position is located in Beijing and reports into the Health Care Compliance Officer (HCCO), Xian Janssen.

PROFILE:
- Requires strong communication, organisational and analytical skills.
- Broad R&D and scientific affairs related experience and a proven ability to influence R&D and SA decisions and the business partners.
- Ability to take complex R&D and SA activities situations and develop solutions to ensure compliance of these activities.
- Background may include Medical Affairs, Compliance, Finance, Sales and Marketing, Legal, Regulatory or Auditing, with Medical Affairs preferred.
- Proven track record in delivering results, self starter and ability to manage complexity a must.

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.
- Under the supervision of the HCCO of XJP, the HCC Senior Manager for R&D and SA will help develop and implement HCC programs that effectively prevent and / or detect violations of law, regulations, policies, or the Code of Conduct in the R&D by:

· Partnering with the R&D and SA leadership team to ensure compliance ownership and right tone at the top.

· Supporting ethical decision-making capability within the R&D and SA by participating in the R&D and SA leadership team meeting, reviewing R&D and SA strategies and other significant initiatives.

· Working closely with GCO and MA compliance functions to ensure R&D and SA activities with HCPs / government officials are planned in consistence with applicable HCC policies, SOPs and R&D specific HCC requirements by reviewing and pre-approving those activities, including RECAP review, GCO Contract review and Protocol review (via participating in the Protocol Review Committee meeting).

· Acting as a consultant, providing day-to-day guidance, advice to covered employees.

· Influencing the development of HCC policies and/or SOPs by sharing insights from R&D and SA, and deploying the HCC Policies and SOPs by providing necessary training and / or communication to covered employees, managing changes, and monitoring implementation.

· Tailoring HCC training materials as appropriate to fit into the needs and business context of the R&D and SA, delivering and coordinating guidance, education, trainings and regular communication to all covered employees.

· Developing and designing HCC monitoring program by working closely with relevant HCC function to identify warning signals and/or gaps for the covered business units and the whole company; providing meaningful feedbacks to R&D and SA leadership and developing appropriate approaches to address the gaps.

· Developing the Management Action Plan relating to R&D and SA by collaborating with relevant functions, and guiding the business partners to close gaps and implement corrective actions.

· Reporting unplanned deviations and supporting HCCO in managing day-to-day allegations and investigations.

· Leading and / or assisting investigations, as appropriate, related to R&D and SA.

· Influencing and stimulating innovative approaches towards HCP's and GOs consistent with the HCC/HCBI guidelines and framework.

· Developing and providing metrics to HCC Officer and COE as required.

· Partnering with R&D and SA compliance function to deliver successful audit and testing, and to support the follow-up actions.
- Interface with legal counsel regarding HCC requirements and interpretation.
- Interface with the global/regional HCC community to share approaches to HCC.

- Interface with R&D and SA compliance function such as GCO and MA compliance.

Qualifications


EDUCATION and EXPERIENCE:
- BA/BS, advanced degree or equivalent preferred
- Minimum of 6 years of working experience in pharmaceutical industry, and demonstrated leadership in HCC or related compliance function (regulatory, quality, finance, HCC).
- Knowledge of the J&J HCBI Guide, FCPA and related regulations, as well as R&D related activity process and related regulations.
- Experience leading in a multi-national environment 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

o Training
- 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 organisation 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

COMMENTS: This position description is an outline of the major recurring responsibilities of the job. It is not intended to be all-inclusive of the work to be performed. Other related job objectives, special assignments and less significant responsibilities will typically be performed by the incumbent(s).

Primary Location:Asia Pacific-China-Beijing-Beijing
Organization: Xian-Janssen Pharmaceutical Ltd. (7043)
Job Function: Health Care Compliance and Privacy