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Therapeutic Area Medical Affairs Lead (Cluster) - Oncology / Hematology

応募 後で応募 求人ID R0009372 掲載日 06/03/2019 Location: Malaysia

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Job Description

OVERALL

  • Develop and oversee all local Medical Affairs activities in the relevant Therapeutic Area (TA) and subsequently executes those plans
  • Maintain a very high level of updated medical knowledge and understanding of the overall treatment and healthcare environment in the Therapeutic Area(s)
  • Leverage strong science to create compelling strategies for the Therapeutic Area (s) that fulfill unmet medical needs, support successful product registration, and increase availability of Takeda’s medicine to patients
  • Represent the Therapeutic Area (s) Medical Affairs to senior cross-functional leadership as well as external stake-holders

STRATEGIC PLANNING

  • Responsible for creating and executing the TA Medical Plan, aligned with both the Brand Plan and the  Area / Regional / Global Medical Plan (where relevant)
  • Provide medical/scientific input into the Brand Plan and is a member of the cross-functional Brand Team
  • Utilize in-field insights to support medical and scientific strategy and business development
  • Identify licensing opportunities and supports due diligence analyses as needed
  • Develop medical strategies through effective and appropriate collaboration with MSL organization

CONTRIBUTION TO ORGANIZATION THROUGH MEDICAL EXPERTISE

  • Lead and/ or participate in the development and implementation of key medical activities (e.g. Advisory Boards, Focus Group Meetings, medical education and peer-to-peer training activities)
  • Create or support the development of medical/scientific materials and slide decks as needed, such as  MSL slide decks and advisory board slides
  • Support Takeda’s speakers’ bureau through addressing educational needs of speakers’ bureau members and faculty
  • Lead identification of educational opportunities that are aligned with Takeda’s medical education strategies and Provides scientific support for continuous medical education (CMEs)
  • Create and deliver relevant Therapeutic Area (s) training to the MSL team and cross-functional teams as needed

CORPORATE GOVERNANCE

  • Contribute or provide medical review of promotional materials for scientific meetings, symposia and other Medical Education activities, in accordance with applicable to Codes of Practice and regulations as well as Takeda policies within defined timelines
  • Ensure that the scientific-medical content of promotional and non-promotional material is fair, balanced, and based on appropriate scientific evidence, as well as compliant with local regulatory norms and internal compliance rules
  • Ensure compliance of all responsible activities to relevant laws and regulations as well as internal standards and SOPs
  • Actively participate in local pharmaceutical industry association / societies committee meetings and has discussions with internal colleagues and other industry  participants on relevant issues  under the guidance of Head of Medical Affairs
  • Support the company reputation and profile by representing the company on cross-company boards as needed

EXTERNAL STAKEHOLDER MANAGEMENT

  • Responsible for representing Takeda in the therapeutic area by providing an expert medical voice with external stakeholders as needed
  • Establishes ongoing relationship with key opinion leaders (KOLs), government officials, healthcare organizations and ensures that significant developments in the field are identified and monitored

CROSS-FUNCTIONAL COLLABORATION

  • Share medical insights in the relevant TA to cross functional colleagues
  • Provide medical and scientific input in the relevant Therapeutic Area(s) to cross-functional stakeholders, including marketing, regulatory, market access / alliance functions and others as required
  • Advise Commercial Teams on medical and scientific matters, including but not limited to scientific approval of promotional materials
  • Provide medical and scientific training to internal stakeholders as needed
  • Participate in  Area / Regional / Global Medical Affairs initiatives

CLINICAL RESEARCH

  • Develop and execute data generation/dissemination plan for the relevant Therapeutic Area (s) in line with the Medical Plan
  • Collaborate with clinical development  teams and provide medical expertise to development in Therapeutic Area (s) as needed 
  • Provide leadership and medical expertise in the development of clinical research programs in line with global strategies to support local product registration and marketing
  • Develop and support local data generation programs to support product registration and marketing
  • Proactively and reactively collaborate with clinical operations to ensure local patients are included in global trials as well as patient recruitment targets are met

PATIENT-CENTRICITY

  • Support the Head of Medical Affairs in planning and implementing patient access programs as needed and as per local regulatory requirements for products within Therapeutic Area (s)
  • Provide medical expertise in the review of adverse events locally and contribute to global pharmacovigilance activities

STRUCTURAL ORGANIZATION

  • May be responsible for budget planning, resource allocation and preparation of monthly / quarterly reports for relevant Therapeutic Area(s)

Locations

Selangor, Malaysia

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

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