drjobs Senior Manager or Manager, Medical Affairs Strategy Scientist

Senior Manager or Manager, Medical Affairs Strategy Scientist

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1 Vacancy
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Job Location drjobs

Tokyo - Japan

Monthly Salary drjobs

Not Disclosed

drjobs

Salary Not Disclosed

Vacancy

1 Vacancy

Job Description

Responsibilities will include but are not limited to the following:

  • Develop and execute the Japan medical affairs strategy and plan for designated products and therapeutic areas in collaboration with MASL.
  • Help identify and effectively interact with key thought leaders patient advocacy groups and institutions to engage in scientific and medical exchange to meet the needs of patients and advance the field of study.
  • Serve as the medical lead on lifecycle strategy including evidence generation strategy development and execution of Phase 3b/4 studies.
  • Assure appropriate close coordination with the Japan commercial and marketing teams to support their efforts including medical expert support for product launches.
  • Collaborate with the Japan field medical team and support reactive material development to address their healthcare provider questions under global guidance.
  • Evaluate and manage Investigator Sponsored Trial efforts including review of protocols and ongoing safety evaluations.
  • Collaborate with the MSL manager on education and training for MSL.
  • Collaborate with medical information specialists on the development and adaptation of the Japan medical information letters and documents.
  • Collaborate with medical communications on the preparation of manuscripts abstracts and presentations for scientific meetings as well as other scientific communications initiatives.
  • Contribute to the development of the global publications plan for designated products and support the optimal execution of the plan.
  • Contribute to the development of internal guidance and resource documents.
  • Provide guidance in the development of strategies to demonstrate the value of disease/products within medical affairs with a focus on outcomes meaningful to payers and clinical decision-makers including Pricing and HTA.
  • Participate in the medical review of branded and unbranded Japan promotional materials market access and health economics and outcomes research (HEOR) materials and medical communications materials to ensure accuracy currency scientific balance and compliance with internal policies and procedures as applicable.
  • Develop an expert understanding of disease state and current medical and/or regulatory issues related to company products.
  • Participate in relevant cross-functional teams and task forces to represent the medical affairs team as needed.
  • Lead and support the Japan alliance partnership (e.g. AbbVie GK) and the development of functional charters from the Japan Medical Affairs perspective.
  • Contribute as requested to the development/editing of other important medical communications to support Medical Affairs activities which might include briefing documents written communications Frequently Asked Question documents etc.
  • Provide medical monitoring and medical oversight for company-sponsored medical affairs-led interventional and observational clinical trials.
  • Assess and supervise Investigator Initiated Studies and Researches.

Experience & Skills:

  • A doctoral degree is required; a Life Science or Clinical degree is preferred.
  • A minimum of 3-5 years of Medical Affairs and/or Clinical Research & Development experience in the pharmaceutical industry.
  • Experience in clinical trial design and conduct (Phases I II or IV) including interventional oncology clinical trials is preferred.
  • Strong compliance knowledge and adherence to corporate compliance.
  • Current working knowledge of country-specific legal regulatory and compliance regulations and guidelines relevant to industry interactions with healthcare professionals.
  • Proven ability to work independently as well as in cross-functional networks.
  • Excellent interpersonal communication and presentation skills strong personal integrity teamwork abilities and a customer focus are necessary.
  • Ability to work cross-functionally with numerous internal stakeholders in a high-matrixed environment.
  • Must be able to organize prioritize and work effectively in a constantly changing environment.
  • Business English level required.
  • This position requires travel (primarily domestic with some international travel).
  • Valid permanent residency in Japan.
  • Native-level Japanese in verbal reading and writing.

#LI-DNP



Required Experience:

Senior Manager

Employment Type

Full Time

Company Industry

About Company

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