Job Description

JOB DESCRIPTION:

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritional, and branded generic medicines. Our 113,000 colleagues serve people in more than 160 countries.

Primary Job Function as Affiliate Head Of Medical Affairs:

• Reporting to the General Manager of Abbott Established Pharmaceuticals Division (EPD), the incumbent will assume full responsibility and accountability for providing leadership to the affiliate\xe2\x80\x99s Medical Affairs activities, Clinical Research activities, Pharmacovigilance (PV) activities and Medical Information services.
• As a member of the Malaysian affiliate leadership team, this position provides medical strategic direction to the affiliate and leads local initiatives involving the local Affiliate Medical Department. In addition, this position has a dotted reporting line to Area Medical Director (AMD).
• Geographical coverage of responsibilities: Malaysia and Brunei.

Primary Job Function in PV:

• During absence of the Affiliate Safety Representative (ASR), the incumbent serves as the ASR back-up for Malaysia and Brunei and ensures that all activities related to pharmacovigilance for both Abbott EPD investigational and registered medicinal products are performed at Affiliate level in accordance with internal Abbott policies and procedures as well as with local regulatory requirements. This includes interactions with local health authorities and representation of pharmacovigilance internally within the Affiliate organization.

Core Job Responsibilities as Affiliate Head of Medical Affairs:

• Medical governance: The Head of Medical Affairs will serve as the Malaysian affiliate contact for medical governance requirements within the affiliate. This will include accountability for understanding compliance requirements, risk identification and assessment, mitigation planning as well as implementation and monitoring of appropriate internal controls.
• Serve as the company\xe2\x80\x99s key medical representative. The Head of Medical Affairs will serve as the Malaysian affiliate medical representative with governmental agencies, professional associations, special interest groups and the healthcare community at large. This will entail interfacing with relevant media groups as appropriate to respond to product queries on a timely basis.
• Provide leadership and direction to the Malaysian affiliate medical services and clinical research staff. The Head of Medical Affairs will support the Malaysian affiliate 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\xe2\x80\x99s business. Ensures that all members of the Medical Department are motivated to contribute fully to the realization of the company\xe2\x80\x99s 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.
• Medical training: The Head of Medical Affairs will ensure that the appropriate Medical training is provided to internal employees (employee orientation, new medical information and refresher trainings). He/she will also participate in appropriate scientific/medical gatherings by serving as the company\xe2\x80\x99s spokesperson in delivering medical training and scientific content to external parties and healthcare professionals.
• Pharmacovigilance: The Head of Medical Affairs will oversee the implementation of effective Pharmacovigilance systems operating within the Malaysian affiliate, 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. The Medical Director or designee will also perform back up Affiliate Safety Representative (ASR) responsibilities.
• Quality Assurance: Ensure and supervise that the affiliate has the appropriate Quality systems in place and adherence of local SOPs to Abbott standards and local regulatory requirements. This includes the handling of product complaints, product recalls/withdrawals, quality audits, management of local third-party manufacturers, GDP management of distributors and warehouses, labeling and finished goods development and management
• Leads the Malaysian affiliate and oversee clinical research activities. The Head of Medical Affairs is primarily responsible for overseeing the management of clinical study activities of the affiliate and leading the affiliate in the design and implementation of all clinical trials and feasibility studies. 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 Head of Medical Affairs 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\xe2\x80\x99s medical development interests. The Head of Medical Affairs is expected to develop and maintain communications within the local research community, with opinion leaders, investigators, industry associations R&D council and corporate headquarters. He/she will represent the company in matters of a medical/scientific nature and public forums.
• Promotional material review & approval process: to oversee the Malaysian 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 affiliate signatory on relevant documents where required.
• Provide medical support to business development and marketing for the medical evaluation of new products, line extensions, and new indications.
• Responsible and accountable for the Malaysian affiliate R & D budget utilization.
• Support the region\xe2\x80\x99s commercial organization in the recruitment and development of relationships with key opinion leaders and in other advocacy initiatives.

Minimum Requirements/ Education:

• M.D. with a solid background in clinical practice, however, suitably qualified individuals with an appropriate scientific background and relevant experience will also be considered.
• Strong functional skill set and scientific rigor
• Business acumen and strategic capability
• A collaborative and team-oriented style
• Solid ambassadorial skills
• Leadership
• Possesses the presence and credibility to establish and maintain productive relationships with a variety of audiences with an interest in the company including government regulators, the scientific community in both academic and private sector environment and other key stakeholders.
• A forward looking, visionary and a strategic thinker with the demonstrated ability to conceptualize the research and development. Focuses on the big picture. Keeps abreast of the external environment. An effective communicator both orally and in writing. Positive, enthusiastic, self-motivated and has a high energy level
• Rapidly adaptable to a changing environment and willingness to assess and implement new ideas and opportunities. Self-starter with vision and initiative and the ability to work unsupervised towards the achievement of challenging goals
• Sound judgment, strong planning and organizational skills, and the ability to get things done

The base pay for this position is N/A

In specific locations, the pay range may vary from the range posted.

JOB FAMILY: Medical & Scientific Affairs

DIVISION: EPD Established Pharma

LOCATION: Malaysia
Selangor : Imazium, No. 8, Jalan SS 21/37

ADDITIONAL LOCATIONS:

WORK SHIFT: Standard

TRAVEL: Not specified

MEDICAL SURVEILLANCE: Not Applicable

SIGNIFICANT WORK ACTIVITIES: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)

Abbott