1. Strategies and Medical affair Leadership
1). Proactive contribute to Local IPS plan and/or LRR cross functionally(MA,SMA).
2). Develops, drive and Lead medical plans under the scope of IPS on behalf of whole
medical affairs function(MA/SMA).
3). Review and approval Promotional and non promotional materials as a faculty
member of materials clearance committee to ensure they are fully aligned with NP4
4). Ensure compliance with safety reporting requirements and RMP execution by
working with DS&E. (AMA/MA/SMA)
5). Review patients compensation claims by suspected AE for assigned products.
6). Proactively contribute and lead the urgent crisis due to patients complaint. (SMA)
7). May serve as reprentatives in GMAT(Global Medical Affairs Team) and
CPT(China Project team sponsored by development) on behalf of China Medical
2. Medical Affairs Studies (MAS)
1). Define, initiate, coordinate and manage local PMS /Observational studies, PhaseIIIb /
IV studies in line with GCP, Local regulations and Global IPS Strategy and plan.
2). Define IIT Strategies and responsible for the whole process of execution of IIT in align
with GCP, Local regulations, including contract, payment and publication. (MA/SMA)
3). Ensures GCP compliance and adherence to Novartis Standard Operating Procedures
(SOPs) for conduct of trial activities. (AMA/MA/SMA)
4). Be responsible for approval process(Local, Global, Central EC) approval for Phase IV
Studies, PMS. (AMA/MA/SMA)
5). Lead and oversee the Budget of medical affairs studies, responsible for the database management, CSR and publication process and results. (MA/SMA)
6). Be responsible for Documents Preparation (Study Concept Sheet, Protocol and final study reports and publications ) of Medical affairs studies. (AMA/MA/SMA)
7). Be responsible for design and implantation of other researches such as Chart review, Registries and meta analysis (MA/SMA)
8). Oversee and management of third party studies, animal/in vitro studies. (AMA/MA/SMA)
9). Responsible for CRO Management(Database and CSR) and Contract management in IIT. (MA/SMA)
3. Scientific Information /Messages Management
1). Define and manage on Key scientific messages for assigned product(s) through scientific slides deck, presentations and other tools. (AMA/MA/SMA)
2). Provide comprehensive Medical presentations and training to internal and external customers, for the accurate delivery of messages. (AMA/MA/SMA)
3). Build strong relationship with scientific associations through advisory board meetings, Steering committees. (AMA/MA/SMA)
1. Preferred Master Degree in clinical medicine with 2+ years experience in clinical practice and / or clinical research (can work in Beijing and Shanghai).
2. Work experience within the pharmaceutical industry and proven knowledge on Global and Local regulations, Code of industry and drug development process.
3. Fluent in Chinese and English writing and speaking.
4. Well-developed planning and time management skills.
5. Strong communication skills.
6. Customer orientation
7. Advanced Knowledge of allocated therapeutic area including patients treatment status and unmet needs, society and KOLs.
8. Strong scientific writing skills and proven evidence of scientific publications in National and international level.