Medical Affairs Manager

3 days ago

กรงเทพมหานคร, Thailand Abbott Laboratories Full time

**Location**: Thailand

**Reporting to**: Head of Medical Affairs and Pharmacovigilance (Cambodia, Myanmar, Thailand)

**Primary Job Function**:
**Medical Affairs Manager**:
The position represents the affiliate’s medical/ scientific voice of expertise for assigned product(s) and relevant therapeutic areas. The position provides medical / scientific expert advice / guidance to key customers for assigned products and relevant therapeutic areas, including scientific exchange and professional relationship development with key opinion leaders. It provides medical / scientific input into marketing strategy and key commercial initiatives, as required, and medical / scientific support for medical department activities under the direction of the Head of the affiliate medical function.

**Affiliate Safety Representative Back-up**:
During absence of the Affiliate Safety Representative (ASR), the ASR back-up in Thailand 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**:
**Medical Affairs Manager**
- Develop and maintain in depth knowledge for assigned product(s)/ relevant therapeutic area(s)
- Provide expert medical/scientific advice for assigned products and related therapeutic areas
- Provide medical/scientific input into marketing strategy and key commercial initiatives, as required. Deliver scientific and medical

education programs to healthcare professionals
- Review and approve promotional materials. Ensure that it is based on good clinical practice, is of the highest standards of medical

accuracy and is fair, objective and balanced
- Develop scientific material and initiates its request for approval
- Co-operation on clinical research activities with the global and regional by taking responsibility for the implementation/ manage of local clinical trials, including IIS, BE, feasibility studies and non-interventional clinical research activities throughout project
- Assures that clinical research program design meets scientific objectives and is aligned with our Medical Affairs Strategy
- Ensure compliance with Corporate and Divisional Standard Operating Procedures SOPs, Good Clinical Practice, and local regulatory

requirements pertaining to the conduct of clinical studies
- Provide monitoring visits and site management for a variety of protocols, sites and therapeutic areas.
- Collaborate and liaise with study team members for project execution support as appropriate
- Serves as scientific expertise on clinical research matters and govern regulatory requirements
- Administer and maintain appropriate documentation such as protocol approval and related study expenditure to internal stakeholders
- Manage internal TARC review and approval of local clinical activities in assigned therapeutic area(s)
- Complete data entry to monthly metric
- Manage CLIMATE and Clinical Tracker Sharepoint

**Affiliate Safety Representative Back-up**:

- Acts as a deputy local PV
- Maintenance of the Affiliate PV System Country Chapter and additional local PV procedures, forms, and templates
- PV business continuity planning and notification of any business interruptions that pose a threat locally or globally to pharmacovigilance processes or endanger regulatory compliance
- Receipt, recording, and reconciliation of safety information
- Safety surveillance including literature and health authority website screening and preparation of local periodic safety reports and Risk Management Plans
- Regulatory submission of safety information
- Basic PV training of local EPD staff
- PV record retention and archiving
- Implementation of out-of-office coverage for receiving and recording safety-relevant information
- Maintenance of local PV product list
- Ensure PV matters in local interventional studies and local non-interventional organized data collection schemes
- Negotiation and implementation of local commercial pharmacovigilance agreements and local pharmacovigilance service agreements
- Due Diligence for product acquisition or in-licensing negotiated by an Affiliate organization
- Provision of local PV Compliance metrics and management of non-compliances
- Coordination/management of PV audits and inspections at the Affiliate level
- Perform vigilance compliant to local legislation for Abbott EPD products beyond medicinal products such as medical devices and food supplements
- Support in preparation of Health Hazard Assessment/Medical Expert Statements
- Perform PV quality checks requiring four-eye review

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