Principle Roles & Responsibilities / Accountabilities
1. Medical Compliance Assurance
1) Lead Medical Compliance strategy execution align with Medical Governance requirements, local regulations and Global standards
2) Lead in developing, implementing, communicating and maintaining medical compliance process with an emphasis on business integrity, operational excellence, and practicality.
3) Drive ethics and compliance training, and supporting compliance-related investigations as well as implementation of corrective actions.
4) Promote ethics & compliance through identification of compliance policy and training needs and development of new and enhanced compliance program activities.
5) Collaborate with key functional area stakeholders to identify risks and issues that may require training and monitoring, and ensure maintenance of policies, processes and investigative protocols on an ongoing basis.
6) Acts as a consultant for business activities that involve Compliance risks, and contributes to departmental process and organizational improvements and development, including management Speaker engagements.
7) Facilitate the audit and Inspection to ensure readiness in advance
2. QMS maintenance and implement
1) Lead China Quality Management System (QMS) maintenance and implementation.
2) Implement Quality Control for medical activities for responsible Function Departments or areas
Plan and conduct the Quality Control to the GCP and GVP governed activities, and ensure the CAPA is carried out by responsible Function Departments
Facilitate cross-functions in preparing for audits/inspections and provide inputs into the generation of timely and appropriate CAPA, and ensure the CAPA follow-ups and completeness
Reflect the quality issues into trainings and standards development and implementation in responsible Function Departments.
3) Lead to optimize medical internal process standard
Lead the development and maintenance of Standard Operating Procedures (SOPs) across Medical Division
Lead in the global quality assurance programs such as Inspection Readiness initiative, Quality Risk Management program (QRM), and etc. and drive these programs implementations in China Medical
Supervise the execution of JD/CV/O-ceahart management process in Medical Division
4) Be LQR Backup to undertake LQR’s key responsibilities on QMS management in China if applicable. Refer to LQR JD for detail information.
3. Lead Medical excellence strategy management:
1) Act as a leader to implement Medical Excellence strategy for Medical Capabilities Enhancement
Drive local Medical Excellence assessment & development process align with medical strategy
Identify improvement areas of Medical Affairs and develop programs to meet the gap for whole division more efficient accomplishing MVP implementation.
Collaborating with Medical Affairs function team to identify focused capability areas for achieving our objectives, building and executing corresponding training plan.
Contribute to the functional competency model in Medical Affairs, with primary focus related to the design and development of adequate trainings and activities for medical excellence.
Perform Industry Benchmarking and Competitive Intelligence – Monitor and analyze industry trends to provide functional insight, guidance and best practices
2) Training Compliance and Optimization
Analyze the learning outcomes and identify solutions in order to maximize learning effectiveness in liaison with relevant functions.
Provide expert consultancy on learning theory and methodology to functional stakeholders within Medical Affairs.
Oversee creation of training material in cooperation with relevant functions. Implement regular review of training material to ensure findings from e.g. compliance analysis and customer feedback are integrated.
Promote a learning environment within Medical where employees assume more responsibility for training and self-learning.
3) Develop and Foster Learning Culture in CMA
Promote a transformative learning culture to adapt agile fit for purpose organization
Develop knowledge and information sharing into a formal process internally and across division
Be KA to maximize the value of CMA through corporation with Roche Academy, PT and Global Learning organization
MA image build up and reinforce medical network through Learning and Sharing platform internally and externally
4. Partnership with the local/global department
1) Local Requirements and Operations
Keep abreast of local regulations pertaining to medical activities that are sponsored or supported by Roche China
Provide interpretation on local regulations and ensure processes are effectively described in terms that will satisfy local requirements.
2) Quality Business Partner
Drive Medical compliance assurance by answering questions and providing advice on ICH-GCP/GVP/HCP Compliance, Global SOPs, and local regulations.
Support responsible Function Department competency development to promote a learning environment
Provide Medical compliance expert consultancy on trainings of required SOPs/regulatory to applicable Medical staffs.
3) Actively build up cross-functional compliance communication and collaboration to ensure an effective and seamless interaction with other functions within and outside Medical Division
Qualification and Experience
1) At least with bachelor degree of medicine / pharmacy / epidemiology / life science or other healthcare related fields, master degree is preferred.
2) Relevant working experience:
At least 4-6 years experiences including experience in clinical and/or pharmacovigilance and/or HCP compliance with at least 2 years’ medical compliance or quality assurance, such as GCP/GVP/major environmental regulations is preferred.
For senior position, at least 6 years’ experience including experience in clinical or pharmacovigilance and 2 years’ medical compliance or quality assurance.
Experience on team development is preferred
Medical Affairs experience is preferred.
3) Working experience as the project leader and or people and budget management in a pharmaceutical organization is preferred.
1) Proven ability to lead and coach medical personnel at skill and knowledge levels.
2) Demonstrated ability to work in a cross-cultural/functional environment.
3) Ability to build an effective team and handle difficult people issues if applicable
Job Required Competencies
1) In-depth knowledge of ICH-GCP/GVP/HCP Compliance, SOPs and local regulatory requirements
2) An independent and analytical thinking, a strong team player
3) Good training and presentation skills
4) Good communication and influence skills
5) Ability to work independently and cooperation with other teams
6) Strong project management skills;
7) Fluent written and verbal English
8) Demonstrated computer literacy, usage of MS Office software, web-based systems and databases.