As a member of the Global Pharmaceutical Research and Development Division and reporting into the Area Medical Head, JAPAC, this position provides strategic direction to the local Affiliate Medical Directors, leads and co-ordinates regional initiatives involving the local Affiliate Medical Departments
•Provide medical governance. The Medical Director will serve as the regional contact for medical governance requirements within the Asia region. The Medical Director will be directly responsible for Singapore, with direct reporting from medical heads in Thailand, Vietnam and Malaysia, Korea, Taiwan and Hong Kong medical departments and will oversee the Abbvie medical representation in Model D countries of India, Philippines and Indonesia and others. This will include accountability for understanding compliance requirements, risk identification and assessment, mitigation planning as well as implementation and monitoring of appropriate internal controls.
•Provide leadership and direction to regional clinical research, regulatory affairs and medical services staff. The Medical Director will support Affiliates to ensure appropriate staffing, training and development in order to meet business needs and deliver quality services. He/she must develop appropriate succession planning to ensure ongoing development of key skill sets in order to minimize disruption to the company’s business. Ensures that all members of the Medical Affairs Division are motivated to contribute fully to the realization of the company’s mission, vision, goals, and objectives. Encourages employees to identify innovative approaches to enhance organizational performance. Fosters the development of management practices, which focuses on a cohesive working environment and continuous improvement in the relationships with internal and external stakeholders.
•Pharmacovigilance: The incumbent will oversee the implementation of effective Pharmacovigilance systems operating within the affiliates, and that reporting requirements to competent authorities for adverse events and other safety related documents are adhered to. The Medical Director should proactively anticipate possible safety signals and communicate appropriately according to standard procedures
•Leverage the organization’s strength in clinical research activities within the global company. The incumbent will oversee the management of clinical study activities of the Affiliates. He/she will oversee the affiliate medical teams to ensure compliance with corporate Standard Operating Procedures SOP’s, GCP, and local regulatory requirements pertaining to the conduct of clinical studies.
•Lead regional and oversee local clinical support activities. The incumbent is primarily responsible for leading regional and overseeing the local affiliates in the design and implementation of all clinical trials and feasibility studies as well as responds quickly and effectively to adverse events by ensuring strong capability in drug safety and Pharmacovigilance areas. He/she will be responsible for leading or overseeing the design and execution of phase IV, and PMOS studies, and for providing the required oversight to manage the review, approval and conduct of IIS. The Medical Director should proactively anticipate possible safety signals and manage expectations broadly to mitigate any negative commercial impact downstream.
•Act as an ambassador to further the company’s medical development interests. The / Medical Director is expected to develop and maintain communications within the local research community, with opinion leaders, investigators, industry associations R&D council and corporate headquarters. This individual will represent the company in matters of a medical /scientific nature and public forums.
•Promotional material review & approval process: to oversee the Affiliate local medical support for providing final sign-off of promotional materials or label changes to ensure that all requested changes are in line with approved product label. To act as regional signatory on relevant documents where required.
•Provide medical support to the marketing and product planning groups for new products, line extensions, and new indications.
•Support the region’s commercial organization in the recruitment and development of relationships with key opinion leaders and in other advocacy initiatives.
•Support public affairs and reimbursement activities within the region.
TECHNICAL COMPETENCIES:
•Management Skills
•Communication Skills
•Compliance& Process Improvement Skills
•Problem/Conflict Solving Ability
•Priority Setting
•Staff Development
LEADERSHIP COMPETENCIES:
o Know the Business
Understand customers, business operations and emerging issues. Base decisions on experience and logical assumption taking into account resources, constraints, risk/reward and organizational values.
o Drive for Results
Establish high goals for organization success and personal accomplishment. Lead to meet or exceed those goals. Create an organization that executes well and makes speed in bringing products to market, accelerates development plans, and thus creating a competitive and regulatory advantage for AbbVie.
o Make Difficult Decisions
Make timely decisions in the face of obstacles, difficulties and challenges. Act decisively demonstrating confidence and the strength of one’s convictions.
o Encourage an Open Environment and Knowledge Sharing
Encourage a culture of open, honest communication where all are encouraged and feel free to express their views. Encourage widespread sharing of information.
o Set Vision and Strategy
Create and deliver a vision of the future to maximize training for enhanced performance. Establish and commit to strategies and a course of action to accomplish that long-range vision. Communicate a clear view of the desired future state.
o Build Organization and Inspire People
Attract and develop people to maximize the collective skills of the project team. Inspire and motivate them to achieve the organization’s strategic intent, vision and goals.
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