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Medical Affairs Manager

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Job ID R0040761 Date posted Aug. 19, 2021 Location Jakarta, Indonesia

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Job Description

Medical Affairs Manager


Therapeutic area             : Gastro Intestinal and IBD
Direct report to                 : Head of Medical Affairs


Scope of Activities & Responsibilities:

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 Local Operating Company (LOC) including strategic planning, resourcing, and budgeting
•    Leverage strong science to create compelling strategies that fulfil unmet medical needs, support successful product registration, and increase access of Takeda’s medicine to patients
•    Provide oversight and leadership to the Medical Affairs team by ensuring that appropriate structures, systems, competencies and values are developed to provide optimal support for pre-approval and post-approval medical programs
•    Manage and collaborate with direct reports to set and achieve appropriate KPIs
•    Facilitate regular coaching of direct reports to improve capabilities and identify areas for future development, including in-field coaching to MSL direct reports
•    Ensure effective team communication and alignment within the Medical Affairs team

COMPLIANCE
•    Oversee and ensure compliance of all Medical Affairs activities with relevant law and regulations, as well as internal Takeda standards and SOPs
•    Serve as final signatory for medical approval of Takeda materials for scientific meetings, symposia and other medical education activities, in accordance with applicable industry Code of Conduct and regulations, as well as Takeda policies, within defined timelines

PHARMACOVIGILANCE
•    Ensure patient safety is prioritized and that adequate QA and PV systems are installed and implemented
•    Provide medical expertise in the review of adverse events locally and contribute to global pharmacovigilance activities as needed
•    Coordinate QA- and PV-activities and ensure QA- and PV- SOPs are in place and are strictly followed. This includes managing product related medical safety issues and provide input on product-related quality issues and incidents to the global PV-team

DATA GENERATION AND CLINICAL DEVELOPMENT
•    Develop and support local data generation programs to support product registration and marketing
•    Collaborate with clinical development teams and provide medical expertise to development as required 
•    Provide leadership and medical expertise in the development of clinical research programs in line with global strategies to support local product registration and marketing
•    Proactively and reactively collaborate with clinical operations to ensure local patients are included in global trials and patient recruitment targets are met

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 a positive team environment to facilitate effective team communication and alignment, both within the medical team and 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

Job Specifications


•    Education: Min. Medical Degree (MD).


•    Experiences:
o    5 - 10 years of Clinical or Medical Affairs experience in the pharmaceutical industry
o    At least 5 year experience in people management
o    Preferred prior experience in the Gastro Intestinal (GI) & Inflammatory Bowel Disease (IBD) field


•    Good reputation in the pharmaceutical industry with established network within the Medical Affairs community


•    In depth expertise in Medical Affairs with proven achievements throughout the life cycle management of innovative medicines


•    Expertise in clinical development, data generation (including real world evidence and pharmaco-economics) as well as familiarity with regulatory, market access and drug reimbursement process.

Locations

Jakarta, Indonesia

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time
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