·Leverage medical expertise in defined therapeutic area to identify the opportunities in life cycle management, participate in the key projects of product life cycle management process;
·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;
·Independently develop medical strategy and action plans for products/indications under charge with high quality and come up with medical initiatives which can facilitate the brand development;
·Ensure medical leadership in generating brand strategy and brand action plan on defined products or therapeutic area, provide strategic and valuable medical analysis in brand strategy developing;
·Review and approval promotional and non-promotional materials to ensure they are fully aligned with regulation guideline and strategy.
·Proactively contribute and lead the urgent crisis due to patients’ complaint.
·Closely working with brand team and other functions to support business, e.g. provide medical input for brand promotional activities, marketing access activities, etc.
Medical Affairs Studies：
·Define, initiate, coordinate and manage local observational studies, Local regulations and Global Strategy.
·Define IIT Strategies and responsible for the execution of IIT in align with GCP, Local regulations, including contract, payment and publication.
·Ensures GCP compliance and adherence to Standard Operating Procedures (SOPs) for conduct of trial activities.
·Be responsible for approval process (Local, Global, and 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.
·Master of clinical medicine, biov-pharmaceutical or biotechnology as minimum.
·More than 1 year in clinical practice is preferred;
·More than 2 years in pharmaceutical or medical device company, including 1year medical strategy role, specialized in dermatology is preferred;
·Previous experience in MSL is a plus.
Required pre-requisites skills/experience for this position:
·Firmly grounded in scientific fundamentals of clinical study protocol development and methodology, data interpretation and scientific communication;
·Capable of developing Country Medical Affairs strategy and tactics;
·Business insights and marketing sense (good understanding pharmaceutical business)
·Ability to function in a team-oriented (matrix) environment；
·Ability to think strategically to guide publication-related activities in accordance with industry standards and good publication practices；
·Fluent English in literature reading, medical writing and oral communication, can independently communicate with global team；
·Excellent Project management skills and Budget control；
·Travel Frequency：> 20%