Johnson & Johnson was founded more than 120 years ago on a revolutionary idea: Doctors and nurses should use sterile sutures, dressings and bandages to treat peoples’ wounds. Johnson & Johnson is ranked by Fortune Magazine as the 3rd most Admired Pharmaceutical Company in the world with an outstanding product range as well as an extensive research base with a number of life saving original research molecules.
Post : SEA Regional Medical Advisor - Haematology
Job Description
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.
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.
Candidate Profile
• 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.
Additional Information
Experience : 3-5 years
Qualification : Scientific Medical Degree, Ph.D, Pharm.D
Location : Singapore
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Medical Affairs
End Date : 28th April, 2019
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