Shanghai, China
Worked in healthcare industry for over 14 years. I had 6 years experience for Medical Business Operation which helps me to build up a strong business sence. And I have almost 8 years compliance experience in consulting & trainning and company policy optimization area. I have good communication skills to cooperate with business stakeholders to enhance their compliance awareness and ensure the company activies are complied with company policy, industry code of conduct and even Chinese regulations and laws.
1. Provide compliance fundamental principles to guide PVP and related projects. Support to improve the general compliance level in daily operation. Facilitate and secure the project/activity forming to ensure full adherence of UCB Ethics & Compliance principles. 2. Provide insights to develop the tailored risk management scheme to ensure the maximum patient and stakeholder value creation and full adherence of UCB Ethics & Compliance principles. 3. As the Compliance Champion and Ambassador in business unit, effectively interact with colleagues to promote compliance awareness and Ethical Decision Making in daily business operation through tailored training and frequent communication, helping BU management to build and promote a culture of Ethics and Compliance, through but not limited to: support plan training schedule and prepare the training materials. Organize compliance workshops and activities to refresh awareness, conduct E&C training (onsite/offsite). 4. Conduct assessment on event and share compliance insights during planning stage to ensure fundamental compliance standards are well followed and communicate with owner for any potential findings. 5. As a key enabler in Project Guardian, conduct a continuous and effective assurance process and act as an independent evaluator of effectiveness of risk mitigation plan, to ensure that the implementation of PVP and related projects meet the highest ethics and compliance standards. Attend critical events engaging HCP and HCO to ensure the lawful promotion in promotional events and/or purely scientific nature in nonpromotional events. Ensure prompt communication of all identified potential risks, and follow‐up on red flags. 6. Provide professional consultations to support to develop the actionable project plans, in conjunction with key stakeholders/project owners. Participate in the development and deployment of the respective business plan.
1. Perform compliance review and approval role in processing of the marketing activities, serve as contact point with external consultant/vendor for on-site check, T&E forensic check, due diligence check of vendors, supplies and sales intermediaries. 2. Make periodic analysis report on compliance implementation status for the management to review. 3. Lead internal investigations, including data analysis, document review and interviews and identify potential areas of compliance vulnerability and risk in China. Assist in continual improvement and development of the existing compliance program, developing, initiate, maintain, and revise policies and procedures for the general operation in accordance with the company’s business needs and the compliance program. 4. Promote compliance communication and education including developing compliance brochure, poster, newsletter, training materials, etc. 5. Work as the business partner for business unit and functional department for the compliance consultant.
1. Work as the gate keeper for the activities oversight to ensure fully transparency and confirm all Roche activities including promotional and non-promotional activities to comply with compliance, regulations, company policy and SOPs. 2. Provide insights, advice & recommendations to optimize project and resource effectiveness. Optimize SOPs & guidelines on activities process, like grant, sponsorship, donation policy and etc. 3. Develop the annual plan for Roche non-promotional activities for assigned products based on educational strategy identified in the Product Medical Plan. 4. Implement non-promotional activities for assigned therapeutic area according to Medical Plan. 5. Maintain and ensure the fully implementation of compliance requirements, to coordinate risk assessment, identify the potential impact, define and drive with appropriate action if any new update of compliance requirements. 6. Plan and manage the corporate level compliance training/communication to business and any other related departments.
1. Drive and design /smooth implementation of process related to clinical research. Facilitate implementation of the process and track the process quality in all lines, prepare regular report out to senior managements 2. Liaison with QC team to ensure standard process related to clinical research in compliance with ICH-GCP and SOP, even with RDPAC 3. Centrally monitoring the usage of clinical trial system, including Plan Source ,Quantum. 4. Liaison with Finance to build Medical study expense system. Calculate the study budget according to study design, patient no. and treatment duration each budget round. Track and monitor the expense and analyses the expense variance.. 5. Implement and optimize the IMP management process. Serve as key contact between Medical and other multifunctional dept. regarding clinical supplies affairs. Provide the training and coaching to new staffs regarding the IMP management process by request. 6. Recruit and maintain CTA team. Provide leadership regarding CTA resource management. Provide training and coaching to subordinates. Set Objectives and conducts performance reviews. Lead, motivate, develop and supervise subordinates to improve and maintain their individual performance.