Bayer is a global enterprise with core competencies in the Life Science fields of health care and agriculture. Its products and services are designed to benefit people and improve their quality of life. At Bayer you have the opportunity to be part of a culture where we value the passion of our employees to innovate and give them the power to change.
Medical Advisor Manager
MAIN TASKS AND RESPONSIBILITIES
- Enhance local medical data generation and Product life-cycle management from medical perspective to maximize product's value and long-term development
- Work with product manager proactively to assist market strategy implementation
- Evaluate new products, new indications, new research programs, new business potentials of defined therapeutic areas from medical perspective to support new product introduction and line extension
- Provide phase IV study direction and develop key elements
- Design and manage local Non-interventional Study (NIS) study as a clinician.
- Develop medical strategy and implement it to support product development
- Develop publication plan and implement it
- Evaluate and review IIR proposal to ensure its scientific standard and strategy fit
- Conduct medical review for products advertising and promotional material. Ensure the promotional material compliant with scientific, ethical and legal requirements.
- Provide medical expert opinion in safety events management to avoid negative impact
- Ensure the studies are complaint with Bayer and ICH guidelines
- Review and approve Local Standard Response Letter to HCPs/consumers
- Co-develop product strategy, positioning, key message with Marketing team
- Provide medical support (topic design, KOL communication etc.) on key marketing activities
- Provide broad and deep medical insight/summary document of the defined therapeutic area to business partners to deal with key product issues such as bidding, RDL, new initiatives etc.
- Align with cross function team including marketing, CO team, global team etc, develop post marketing research strategy based on Registration/Market needs
- Provide support from Medical and Scientific side to clinical development
- Establishes and approves scientific methods for design and implementation of clinical protocols, data collection systems and final reports.
- Monitors adherence to protocols and determines study completion.
- Support to registration strategy
- Coordinates and develops reporting information for reports submitted to the SFDA
- Prepare the medical sections of regulatory submissions
- Perform medical evaluation, explanation on the event
- Develop medical justification or responding document
- Provide medical expert opinion on company responding strategy
- Review and approve all external communication documents to make sure all delivered message are medically precise and consistent
- Communicate with external customers directly for medical issues as necessary
- Hires, develops, and manages personnel.
- Trains and evaluates team competencies through coaching, feedback and training
- Manage the cost and payment for IIR and NIS
- Get alignment of the study concept with commercial team and ensure the efficiency of the cost
WHO YOU ARE
- Clinical Medicine Background is preferred, bachelor’s degree or above
- A minimum of 4-6 years multinational pharmaceutical industry experience in medical affairs, OTC experience is preferred
- Fluent English in literature reading, medical writing and oral communication
Are you looking for a new challenge where you can show your passion for innovation? Are you interested in working as part of a global team to improve people’s lives? Then send us your online application including cover letter, CV and references.
Bayer welcomes applications from all individuals, regardless of race, national origin, gender, age, physical characteristics, social origin, disability, union membership, religion, family status, pregnancy, sexual orientation, gender identity, gender expression or any unlawful criterion under applicable law. We are committed to treating all applicants fairly and avoiding discrimination.
Reference Code: 216082
Functional Area: 医学事务&药物警戒