AlamatDescription
The Regional Medical Advisor, Southeast Asia (SEA) is a member of the Regional Medical Affairs Department and plays a major role in providing inputs and comments on branding and medical strategic development within assigned therapeutic areas.
This is an exciting opportunity for someone who wants to work across different markets, understand the unmet needs and advocate and elevate the SEA region to have more of a footprint in the region. We are looking for someone who wants to work in innovative portfolios and shape the path for SEA Medical Affairs.
You will 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. You'll be responsible for the development, review and approval process for its therapeutic area’s company sponsored/collaborative studies; and review and approve investigator-initiated study proposals including executing studies sponsored by regional medical affairs. You will also be responsible for all related medical educational events, to respond all related medical information enquiries within its therapeutic area and for regulatory/PV/LSO supports to ensure the accrual medical information/safety assessments are met.
Responsibilities:
- 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 up with current with scientific and medical advances in the assigned therapeutic area.
- 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
- Support the development of study proposals for post registration regional studies
- Medical Affairs support 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
Qualifications
- Scientific Medical Degree MD, Ph. D, PharmD or equivalence.
- Minimum 3-5 years’ experience in pharmaceutical Medical Affairs.
- Experience in clinical practice preferred.
- Innovative portfolio experience and experience working at a regional level
- Understanding of SEA regulatory policies and industry’s codes of practice related to drug registration, pharmaceutical promotion and clinical study required.
- Interpersonal and communication skills to effectively interact with a broad range of external and internal personnel.
