Strategies and Medical affairs Leadership
- Proactive contribute to Local integrated product strategy (IPS) and/or launch readiness review cross functionally.
- Develop and implement the local medical plan and ensure alignment with the brand plan
- Review and approval promotional and non-promotional materials to ensure they are fully aligned with regulation guideline and strategy.
- Review patients’ compensation claims by suspected AE for assigned products.
- Proactively contribute and lead the urgent crisis due to patients’ complaint.
- May serve as representatives in GAMA (Global Aesthetic Medical Affairs) and CPT (China Project team sponsored by development) on behalf of China Medical team.
- Provide the company internal stakeholders with an understanding of the local medical community, clinical practice, trends, and or perceived gaps in current scientific knowledge and medical treatment, competitive intelligence
- Develop and implement pre-launch medical plan/activities for new products at least 2 years prior to the planned launch in the country to address key clinical and scientific challenges
- Provide medical leadership on faculty and content development for medical programmes including national congresses, advisory boards, scientific exchange meetings, publications, CMEs to meet identified needs
Medical Affairs Studies
- Define, initiate, coordinate and manage local PMS /Observational studies, Local regulations and Global IPS Strategy and plan.
- Define IIT Strategies and responsible for the whole process of execution of IIT in align with GCP, Local regulations, including contract, payment and publication.
- Ensures GCP compliance and adherence to Allergan Standard Operating Procedures (SOPs) for conduct of trial activities.
- Be responsible for approval process (Local, Global, Central EC) approval for Phase IV Studies, PMS.
- Lead and oversee the Budget of medical affairs studies, responsible for the database management, CSR and publication process and results.
- Be responsible for Documents Preparation (Study Concept Sheet, Protocol and final study reports and publications) of Medical affairs studies.
- Be responsible for design and implantation of other researches such as Chart review, Registries and meta-analysis
- Oversee and management of third party studies, animal/in vitro studies.
- Responsible for CRO Management (Database and CSR) and Contract management in IIT.
- Recruit the right talent for the role of Medical advisor (MA) based on scientific or technical ability
- Manage and drive MA’s performance in the following objectives
- Conduct one on one meeting/field visit to coach and review MA’s capabilities
- Develop fundamental training for development of on MA’s capabilities initially and sustain trainings (capabilities and/or scientific knowledge) after one on one coaching if needed
- Retain and develop high performing MAs through ongoing development
Scientific Information /Messages Management
- Define and manage on Key scientific messages for assigned product(s) through scientific slides deck, presentations and other tools.
- Provide comprehensive Medical presentations and training to internal and external customers, for the accurate delivery of messages.
- Build strong relationship with scientific associations through advisory board meetings, Steering committees.
Education and Experience
– Above Master Degree in clinical medicine with 7+ years on relevant experience of medical affairs in pharmaceutical company
– 5+years experience in people and budget management in a pharmaceutical organization is preferred.
– Work experience within the pharmaceutical industry and proven knowledge on Global and Local regulations, Code of industry and drug development process.
– Fluent in Chinese and English writing and speaking
– Well-developed planning and time management skills;
– Strong communication skills;
– Customer orientation;
- Advanced Knowledge of allocated therapeutic area including patients’ treatment status and unmet needs, society and KOLs.
- Strong scientific writing skills and proven evidence of scientific publications in National and international level.