Medical Affairs and Ethics

4 weeks ago

Jakarta, Indonesia Takeda Pharmaceutical Full time

**1. Objective**

Medical Affairs Ethic & Compliance Manager will play a pivotal role to support and work closely with the business and other functions, providing quality and compliance oversight of company activities, ensuring that activities are conducted in accordance with applicable regulatory requirements, guidelines and Takeda established quality standards and practices, facilitating risk management and the conduct of business in an ethical and compliant manner.

**Medical Affairs**:

- Providing medical affaris support for Tapros, Borraginol, Esilgan and Vitacimin.

***Ethic & Compliance**:

- Reviewing compliance relate to control of the operation of the company
- Conducting compliance monitoring
- Providing control report including advice and recommendation for control improvement surrounding control environment, gap and deficiencies
- Conducting compliance related training / tracking / updates
- Supporting for compliance initiatives / programs

**2. Activities and Responsibilities**:
**Medical Affairs**:
**MEDICAL LEADERSHIP**
- Represent the Medical Affairs function to senior cross-functional leadership as well as external stakeholders
- Provide medical expertise, governance and leadership to the cross-functional brand team
- Provide oversight, input, and final approval of Medical Plans
- Oversee Medical Affairs contribution and pro-actively provide input into the development of Brand Plans
- Collaborate with local senior management to develop strategic product plans to ensure timely entry of new products to the market and the continuous success of existing products in the market
- Provide updates to senior management on Medical Affairs activities

**MEDICAL EXCELLENCE**
- Responsible for the medical function in the company, including strategic planning, resourcing, and budgeting
- Leverage strong science to create compelling strategies that fulfil unmet medical needs, and improve access of Takeda’s medicine to patients
- Ensure that appropriate structures, systems, competencies, and values are developed to provide optimal support for medical programs
- Ensure cross functional team communication and alignment

**DATA GENERATION AND CLINICAL DEVELOPMENT**
- Develop and support local data generation programs when applicable

**ACCESS TO MEDICINE**
- Responsible for medical leadership in planning and implementing patient access programs as needed, as per local regulatory requirements, and in line with Takeda policies
- Ensure patients under patient assistance program (if any) have access to products, whilst strictly complying with Takeda SOP’s and applicable industry Code of Conduct

**INTERNAL AND EXTERNAL ENGAGEMENTS**
- Enable and support effective internal communication and alignment, with cross-functional stakeholders
- Establish professional relationship with key opinion leaders (KOLs), government officials, healthcare organizations; and ensure that significant developments in the field are identified and monitored
- In collaboration with Head of Medical Affairs (or other Medical Affairs team member) represent Takeda in local pharmaceutical industries association meetings; and regularly analyze industry trend to follow-up and discuss with internal colleagues and relevant stakeholders

**Ethic & Compliance**:

- Responsible in implement, oversee and track Takeda’s Global Code of Conduct and Global Anti-Corruption Policy and guidelines
- Responsible in Implement and track training program and systems to support Takeda’s Compliance program
- Responsible in Implement, operate and track policies, procedures and systems for compliance related matters.
- Responsible the implementation, operation and tracking of Takeda’s policies, procedures and systems relating to Transparency in respect of Takeda’s dealings with healthcare professionals, Patient Organizations and other relevant third parties, including in connection with cross-border interactions
- Responsible in implement and oversee Takeda’s third-party due diligence policies, procedures and systems
- Review control procedures and policies and perform such procedures to verify that controls are operating.
- Together with relevant function, develop and monitor the implementation of appropriate standard operating procedures, to ensure adherence with global Takeda policies and local policies, regulations and law.
- Limited support in Implement and oversee Takeda’s Hotline and reporting systems, respond to hotline calls and reports, and other ethics and compliance-related inquiries, in close coordination with Regional Compliance Officer.
- Assist to conduct local country compliance investigations to investigate violations or alleged violations of the Global Code of Conduct or any other relevant Takeda policy or procedure in line with Takeda issue handling procedures Review the responses to both internal audit and external audit management letter to ensure that recommendations are implemented, in accordance with audit action plan and fi

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