13 May, 2022
Position Title: Medical Affairs Manager, Asia Pacific, Digestive Health
- Oversees high scientific quality communication with Leading Specialists, KOLs, Surgeons, Regulatory Agencies and medical Societies to communicate value of J&J 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 Medical Affairs projects
- 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 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.
- Engage with external stakeholders such as opinion leaders, research organizations and database owners
- Identify a range of suitably qualified and experienced vendors and suitable data sources to meet the different real-world evidence (RWE) generation requirements
- Drive collaboration amongst multiple stakeholders (Global / Region) and markets to efficiently generate impactful evidence and successfully achieve key objectives.
- Works closely with cross-functional project teams to identify clinical development plans in support of assigned innovation projects for Selfcare.
- Lead integrated evidence generation across RWE, Phase IIIb/IV, HEOR for Selfcare
- Insight generation to build NPD pipeline for Selfcare and drive evidence generation.
- Responsible for the Clinical Evidence Generation strategy to advance TA and Product science.
- Build and execute the Publication plan (clinical data generated from clinical trials, review articles, posters, expert opinion, consensus recommendation, guidelines)
- To act as a medical and clinical expert including innovative product and claims development.
- Contributes to claims generation, development of Brand Medical plans and NPD Launch Plans.
- Provide oversight to the Investigator Initiated Studies (IIS)
- Provides clinical guidance and input in the choice and design of clinical study methods
- If medically qualified, provides medical oversight on assigned clinical studies.
- To lead discussions and implement plans for clinical development programs.
- To ensure all clinical activities are conducted in accordance with high ethical/quality standards and all applicable GCP/ICH regulations and company procedures.
- To co-author clinical protocols as required in the development of new products.
- Building understanding of latest thinking and trends in the field, build and execute clinical trial with novel trial designs and endpoints.
- Generate insights and identify areas for evidence generation through HCP interaction/ scientific advisory board meetings.
- Awareness of new developments in RWE analytics, data, and technology which may be applied to the design and execution of observational research.
- Manage specific ISS and support facilitation of ISS.
- Provide medical and scientific expertise to support product launches, key scientific meetings, relationship management with leading research physicians and critical evaluation of current literature.
- Has significant knowledge in the statistical and clinical interpretation of study results and broad knowledge of regulatory requirements for drug development.
- To assist Regulatory Affairs in submission activities within assigned projects and contribute to the preparation of submission documents to regulatory agencies, be the point of contact for Health Authority communication.
Job scope/related tasks
- Assist in proactive local key opinion leader management.
- Ensure 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 key objectives.
- Contributes to development and implementation of local medical plans 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.
Required Competency and Skills:
- An advanced degree (e.g., PhD or Pharmacy or MD) is required. An MD or equivalent is preferred
- At least 5 to 8 years 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
- Excellent communication and written skills
- Ability to translate strategy into tactics
- Ability to work in a matrix environment with local, regional, and global cross-functional teams is essential
- May require up to 10% annual travel
Apply through this Link