
Sea Regional Medical Advisor
4 days ago
The SEA Regional Medical Advisor directs the operational function in medical affairs to achieve organizational objectives. Responsible for the design, development and implementation of programs related to educational, promotional and reporting materials for products related to Phase IIIb, Phase IV trials, solicited and non-solicited studies, publications, and so on.
- The SEA Regional Medical Advisor is a member of Regional Medical Affairs Department and plays a major role in providing inputs and comments on branding and medical strategic development within assigned therapeutic areas.
- Collaborate with internal and external stakeholders as well as key thought leaders to develop and implement the overall medical strategy for new and developing products in alignment with therapeutic brand strategy as well as company strategy.
- Responsible for the review and approval process for its therapeutic area’s company and investigator initiated study proposals. Execute studies sponsored by regional medical affairs.
- Responsible for all related medical educational event, to respond all related medical information enquiries within its therapeutic area. Responsible for regulatory/PV/LSO support’s to ensure the accrual medical information/safety assessments are met.
Act as Medical Affairs Expert and provide input into strategy for the assigned Therapeutic Area
- Lead the execution and supervision of all regional medical affairs activities.
- Provide consultation to local Medical Information department or act as Medical information specialist with regard to the assigned therapeutic area.
- Provide expert medical leadership into issues management (e.g. product withdrawals, safety alerts etc.).
- Co-ordinate the medical response to requests for scientific exchange of information from external customers and at key internal meetings.
- Work with regional commercial team to develop strategies to support brand commercialization activities.
- Ensure all Medical activities are conducted within the Company Compliance Principles
- Deliver medical insight into Product Life Cycle Management planning.
- Keep current with scientific and medical advances in the assigned therapeutic area.
Medical Education/Advisory Board
- Manage and execute regional Medical Education events, including company standalone program, scientific symposia, publications, speaking engagements, and advisory board meetings etc.
- Build up or enhance a trusted collaboration with the external scientific community and thought leaders.
Study Planning and Execution
- Support the development of study proposals for post registration regional studies
- Support Medical Affairs to evaluate Investigator Initiated Studies (IISs) proposals for scientific soundness and whether those are in alignment with the medical strategy
- Participate in study planning, e.g., with respect to evaluation of business needs, timelines, grants and investigator/ site selection
- Participate in study start-up meetings and other activities to provide the appropriate training and information to investigators and site personnel
- Support Clinical Operations, when needed, to address any questions and/or clarify issues arising during the conduct of studies
Review and approve medical material, training material and medical information document
Provide Medical and Scientific training for internal and external stakeholders
Work in collaboration with local Medical Affairs for post registration medical data gaps and clinical trial needs and to drive the development of necessary protocols
Support pharmacovigilance and Health Economics with medical input as appropriate.
**Qualifications**
- Scientific Medical Degree, Ph. D, PharmD or equivalence.
- 3-5 years’ experience in pharmaceutical Medical Affairs is required.
- Experience in professionals working environment in the pharmaceutical or related industries preferred.
- Understanding of local regulatory policy and industry’s code of practice related to drug registration, pharmaceutical promotion and clinical study.
- Interpersonal and communication skills to effectively interact with a broad range of external and internal personnel.
- Awareness of, and adherence to, Johnson & Johnson Credo values and International Health Care Business Integrity Guide
**Primary Location**
Malaysia-Selangor
- **Other Locations**
Asia Pacific-Philippines-Bicol, Asia Pacific-Vietnam-Bac Giang, Asia Pacific-Thailand-Bangkok-Bangkok, Asia Pacific-Indonesia-Jawa-Jakarta Raya, Singapore-Singapore-Singapore
**Organization**
Johnson & Johnson Pte. Ltd. (8435)
**Job Function**
R&D
**Requisition ID**
2206049761W
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