Johnson & Johnson 职业机会
Real World Evidence Study and Publication Manager
Requisition ID: 1805684734W
OVERALL PURPOSE OF JOB:
Medical Affairs RWE study Management
• Lead and work with medical colleagues to develop observational research in study plan and protocol design and statistical analysis of company sponsored study or collaborative study, investigator-initiated study.
• The Manager works cross-functionally to support the Content, tactical and execution of observational research across the portfolio.
• Collaborate with Global and Regional team on data generation strategy development and implementation in China
• Cooperate with medical & medical affair operation team to provide leadership and operational excellence for the execution and conduct of real world studies, responsible for the periodical report including issues identified and action plan.
• Manage and track the study timeline, study budget and products of company sponsored studies and collaborative study.
• Ensure the clinical studies are in compliance with local regulations, company SOPs.
• Establish and lead local review and tracking processes.
• Vendor selection and management if the outsourced service is needed.
• Ensure stringent compliance when fulfill the above responsibilities.
Medical Publication Management
• Establish the local working model for publication based on company SOP and local regulation.
• Oversee publication owned by Medical Affair and ensure the compliance.
2.1 ESSENTIAL KNOWLEDGE & SKILLS:
• Education& Qualifications:
- PhD or Master Degree in Clinical Medicine or Epidemiology.
• Solid knowledge and skills in study design, statistical analysis, and clinical study.
• Excellent communication, organizational skills, and influencing skills, good capability to set up collaborative relationship
• Strong planning, project management and execution skills.
• Good operational capability. Ability to work under pressure, to take accountability and meet deadlines
• High responsibility and ownership.
• Adherence to Johnson & Johnson Credo and have the right compliance mind-set.
• Language: Proficiency in oral and written English
• Over 3 years of diverse healthcare experience in medical or clinical research in pharmaceutical, medical device or CRO companies.
- In-depth experience in oncology, immunology or neuroscience disease areas will be plus.
• Rich experience on medical affair and project management.
• Solid experience in Publication in peer reviewed scientific journal.
• A good understanding of the varying medical and marketing practices and perspectives across China, regional and overseas experience is a plus.
• Experience in leading cross function projects
• External collaboration experience