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.
AbbVie is an equal opportunity employer including disability/vets. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a disabled veteran, recently separated veteran, Armed Forces service medal veteran or active duty wartime or campaign badge veteran or a person’s relationship or association with a protected veteran, including spouses and other family members, or any other protected group status. We will take affirmative action to employ and advance in employment qualified minorities, women, individuals with a disability, disabled veterans, recently separated veterans, Armed Forces service medal veterans or active-duty wartime or campaign badge veterans. The Affirmative Action Plan is available for viewing in the Human Resources office during regular business hours.