Description

Main responsibilities

CLINICAL RESEARCH

? Works closely with cross-functional project teams to identify clinical development plans in support of assigned innovation projects including smoking cessation clinical projects

? Responsible for successful execution and delivery of clinical studies in assigned clinical projects.

? Provides clinical guidance and strategic input in the choice and design of clinical study methods

? Plans and directs clinical studies to ensure delivery of key study milestones

? If medically qualified, provides medical oversight on assigned clinical studies

? Monitors and reports findings to senior management and facilitates understanding of clinical trial results

? Independently initiates and manages operational aspects of company sponsored clinical trials in accordance with Johnson & Johnson global standards/guidelines and international regulations (GCP/ICH), including oversight, budget and timelines and act as liaison with study sites and external service providers as needed.

? Ensures all clinical activities are conducted in accordance with high ethical/quality standards and all applicable GCP/ICH regulations and company procedures.

? Co-authors clinical protocols as required in the development of new products.

? Assists Regulatory Affairs in submission activities within assigned projects and contributes to the preparation of submission documents to regulatory agencies.

? Clinical point of contact for Health Authority communication.

MEDICAL AFFAIRS

? Oversees high scientific quality communication with Leading Specialists, KOLs, Surgeons, Regulatory Agencies and medical Societies to communicate value of J&J smoking cessation products, host formal discussions and understand key needs, key value drivers, practical treatment patterns, scientific activities.

? Oversees response to unsolicited scientific queries of customers for approved products and products/indications in development based on Medical Affairs and Medical Information documents

? Acts as an internal medical consultant to provide expert medical support to commercial and HCC partners

? Contributes to developing vision and executes initiatives for analyzing treatment paradigms, discussing J&J products, supporting regulatory approval/ clearance, health technology assessment, monitoring patients’ treatment trends as well as studies in therapeutic areas and engagement of Leading Specialists (Physicians, Pharmacists, medical societies ) and stakeholders

? Initiates, develops and executes Smoking Cessation Medical Affairs projects

SOP-009734, v1.0

F2

? Develops, plans and oversees execution of Medical Education programs and activities

? Organizes and participates in Advisory Boards

? Provide medical training and scientific support to stakeholders

? Provide medical and scientific expertise to support product launches, key scientific meetings, relationship management with leading research physicians and critical evaluation of current literature

? Checks scientific data provided locally to HCPs/ Authorities/ Regulators for compliance to regulations

? Reviews and approves medical, promotional, market access and other informational material for country consumption

? Contributes to claims development strategies and implementation for new and marketed products

? Has significant knowledge in the statistical and clinical interpretation of study results and broad knowledge of regulatory requirements for drug development

? Collaborates in developing responses to Health Authority queries and requests for information.

II. Work Assignments Description

Job scope/related tasks

Assist in proactive local key opinion leader management.

Accountability

Ensures all activities are conducted in accordance with high ethical/quality standards and all applicable policies and procedures.

Manages clinical programs in order to successfully achieve strategic objectives.

Contributes to development and implementation of local medical strategies and claims support, copy and label reviews, review/approve communications for consumers and healthcare professionals, as well as the operational execution of complex programs and initiatives.

III. Required Competency and Skills:

? An advanced degree (e.g., PhD or PharmD or MD) is required. An MD or equivalent is preferred

? At least 3 to 5 years clinical research and medical affairs experience is preferred

? Solid professional knowledge of medicine and of scientific methods applied to clinical research

? Strong commitment to compliance with relevant rules and procedures, and to scientific quality and integrity

? Strong collaboration and interpersonal skills

? Results oriented and able to independently create and deliver

? Strong communication and presentation skills

? Strong leadership skills

? Knowledge in relevant local and international standards for the conduct of clinical studies

? Decision making and Problem Solving Skills

? Good command of English for both conversation and writing

? Ability to translate strategy into tactics

? Ability to work in a matrix environment with local, regional, and global cr? Ability to work in a matrix environment with local, regional, and global cross-functional teams is essential

? Experience in smoking cessation is preferred but not required

? May require up to 10% annual travel

上班地址：漕河泾工业开发区