Senior Medical Affairs Manager
An exciting opportunity has arisen for a talented Senior Medical Affairs Manager in South Korea. The chosen candidate will be expected to supply medical insight, learning materials and scientific input regarding product strategy.
- Lead the medical affairs organisation for the assigned therapeutic area with responsibility for the generation of medical strategy development through the design of phase IIIb and phase IV studies.
- In addition to the generation of scientific data to support medical claims, provide input for the generation of health economic outcome data to support reimbursement.
- Oversee the alignment of medical strategies and communication plans, support resources and budget to ensure the medical and commercial needs/opportunities of the oncology business are met.
- Support integration and communication to regulatory and development teams with strategic medical input where appropriate; ensure medical affairs activities are scientifically sound, within relevant guidelines, and of a high standard.
- Recommend new Country studies, medical affairs activities and investments to Global Medical Affairs leadership via Country Medical Director
- Ensure compliance with Country directives for, amongst others, the release of promotional material and medical representative training materials.
- Lead and participate in Country/Regional Medical and Scientific forums (i.e., advisory boards and educational) that involve scientific leaders.
- Provide support to the Local Safety Officer, who has accountabilities as follows:
- Development and maintenance of country/regional procedures required for local compliance and global company needs.
- Receipt and follow-up of locally originating adverse event reports.
- Where required activities for the local responsible or local contact person for Pharmacovigilance as defined by local legislation
- Authorized personnel within the Local Affiliate Offices to have access to the Global Safety Database
- Review of local literature
- Monitoring of local pharmacovigilance requirements and maintenance of local legislation repository in collaboration with Global Safety Operations
Skills and Requirements
- M.D. physician or equivalent with significant experience in all aspects of clinical trials and professional knowledge and skills working with hemato-oncology therapeutics in either solid tumour or hematology indications.
- Relevant pharmaceutical or related industry experience (5-10 years) in heamto-oncology with a proven track record of contribution to commercial, medical and/or clinical development strategies (in-country/region).
- Understanding of commercial and scientific needs on a local and global basis.
- Proven ability to translate and appropriately align commercial and scientific goals and objectives and to interact productively with both commercial and scientific colleagues.
- Highest ethical standards in corporate medical governance.
- Excellent written and oral communication skills.
- English proficiency a must.
- Applicants must have unlimited working rights in Korea to be considered.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.