Medical Affairs Director
Abbott Laboratories
Main responsibilities:
Ensure strategic planning on medical affairs projects is done including the monitoring of all clinical research activities sponsored by Abbott to ensure compliance with ethical and regulatory standards. Accountable for tactical implementation according to timelines and the allocated budget. Prepare reports on clinical or other research projects.Work with regulatory affairs to ensure new product registration and maintenance of existing marketing approvals for Abbott Nutrition products in Taiwan are done in a timely manner according to the registration plan. Review and sign-off regulatory packages prior to submission, which includes all promotional materials, label changes and product monographs to ensure compliance with local and corporate requirements.Establish and maintain liaison with government authorities, hospitals, and the medical profession. Communicate with Abbott global Research & Development organization, Medical Safety & Surveillance and senior Abbott management and command their support regarding changes and development in the local regulatory environment and the implication of business impact.Ensure collection and submission of safety information of Abbott products (primarily adverse events and adverse reactions) to Abbott Medical Safety & Surveillance and to the relevant authority in Taiwan in compliance with Abbott policy and local requirements.Participate in product launch planning to ensure the plans comply with the regulatory requirements in Taiwan and that medical and scientific guidance is provided throughout the process.Support brand activities by providing medical-marketing support to the commercial teams for both upstream and downstream activitiesEnsure that product complaints are handled well and in a timely manner and that medical support and information are provided to the sales teams, customers, and patients / consumers.Establish health economics expertise in the affiliate to address the growing demand for economic evaluation studies to support listing and reimbursement of Abbott Nutrition’s products.Serve as the affiliate’s key medical spokesperson and primary medical representative with governmental agencies, professional associations, industry organizations, special interest groups, relevant media groups, and the healthcare community at large.
Minimum qualifications:
Doctor of Medicine (M.D.)An M.D. with knowledge / expertise on nutrition and pharmaceutical medicine is preferred.Previous nutritional, pharmaceutical, or biopharmaceutical industry experience is essential, and management experience of 5 years (minimum) is ordinarily expected
Required competencies:
Experience and proven track record of success in clinical research, regulatory, medical safety, and marketing interactions.Fluency in EnglishExcellent communication, presentation, networking, and people management skillsSound judgment, strong planning and organizational skills, and the ability to lead a team and to get things done
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