Senior Specialist / GRA Operations_Biopharma (Tokyo)
Merck
Tokyo, Japan
2 日前

A career at our company is an ongoing journey of discovery : our 58,000 people are shaping how the world lives, works and plays through next generation advancements in Healthcare, Life Science and Electronics.

For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others.

Key Accountabilities :

  • Operationally execute planning, compilation and dispatch of submissions to PMDA during the application lifecycle
  • Be responsible and accountable for information disclosure to PMDA / MHLW, supported by managers
  • Co-lead Japan STF with Japan Regulatory Lead and complete Japan submission on time by collaborating with Global RPM
  • Communicate process, timelines, and document standards to authors
  • Collaborate with publishing vendors, resolve or coordinate any queries, supported by Managers
  • Improve quality of submission standards and templates for submission-relevant documents ensuring compliance with PMDA requirements, supported by Managers
  • Strategic Impact :

  • Utilize systems and tools to plan and track regulatory activities and also ensure compliance to internal processes and HA obligations (e.g. VEEVA Vault RIM)
  • Gather information about electronic e-submission capabilities from internal and external sources
  • Scope of People Responsibilities :

  • Manage own tasks and workload
  • Demonstrate positive attitude
  • Act a team player
  • Cooperation :

  • Internal : Collaboration with GRA Operations, GRA Japan and Japan STF
  • External : Publishing vendor, MHLW / PMDA, Networking with Regulatory Operations in Pharmaceutical industries
  • Candidate’s Profile

    Work Experience :

  • Professional experience in Regulatory Affairs (1 year and more) and / or Pharmaceutical Industry experience (approximately 3 years)
  • An understanding of the role of Regulatory Affairs function, and regulatory operations (publishing experiences is preferable)
  • Project Management experience in planning / tracking submission timelines, supported by Managers
  • Job-Specific Competencies & Skills

  • Working experience to work with multidisciplinary teams within a matrix
  • Japanese and English fluency : Good speaking and writing skills
  • Ability to work diligent in order to ensure required document quality
  • Goal-oriented and practical approach to work
  • Thinking of customer orientation
  • Strong communication skills
  • ADA Requirements (mandatory for US Employees)

  • Normal and routine office duties
  • Education :

  • Degree in Life Science or related discipline (in general)
  • Recruiting Contact : Nozomu Yokota

    What we offer : With us, there are always opportunities to break new ground. We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons.

    We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life.

    Join us and bring your curiosity to life!

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