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Discovery & Pre-Clinical/Clinical Development

[Janssen] R&D, Senior Specialist/Manager, Pharmacology Group, Pre-clinical, Regulatory Affairs

  • Título [Janssen] R&D, Senior Specialist/Manager, Pharmacology Group, Pre-clinical, Regulatory Affairs
  • Función Discovery & Pre-Clinical/Clinical Development
  • Sub función Pharmacology
  • Categoría Principal Scientist, Pharmacology (ST7)
  • Ubicación Chiyoda, Tokyo-To, Japan
  • Publicado
  • Identificación requerida (Req ID) 2406170715W
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Descripción

JOB SUMMARY: Briefly state the objective of this position.

  1. Conduct 1) to 4) below in the non-clinical area for assigned projects.
      1) Assess the feasibility of assigned projects from non-clinical perspectives.
      2) Review non-clinical operations related to clinical studies, NDA's and approvals.
      3) Identify and resolve problems.
      4) Provide support to the team members.
  2. Focus on self-evaluation, self-management and self-development.
  3. Educate and coach junior staff of the group.

KEY RESPONSIBILITIES: List major responsibilities and duties of the position.

1. Conduct 1) to 8) below in the non-clinical area for assigned projects.
    1) Research global (e.g. JJPRD) documents and published papers, and see whether or not the study items and/or results meet requirements by the Japanese regulatory authorities, and see whether or not there is a critical issue against clinical studies and/or NDA's.
    2) Make and discuss possible resolutions to a problem for clinical studies and/or NDA's with relevant colleagues, and put the most appropriate resolution (e.g. additional studies and/or documentation) into practice.
    3) Prepare high-quality non-clinical documents for clinical studies and/or NDA's.
    4) Prepare high-quality non-clinical responses to inquiries for clinical studies and/or NDA's in cooperation with global, JPKK and/or external experts.
    5) Provide support for preparing high-quality documents for marketing.
    6) Discuss the requests for non-clinical studies from external investigators with relevant colleagues, and perform joint studies if needed.
    7) Provide relevant colleagues with suggestions from non-clinical perspectives.
    8) Establish, maintain and improve relationship to relevant colleagues and external experts.
2. Provide advice and/or guidance to junior staff of the group.

Calificaciones

REQUIREMENTS:
Describe the requirements for the position. Include any degrees, certifications, language, or computer skills etc. which are required and/or desirable

Experience/Knowledge

・ Expert knowledge of the non-clinical area, advanced knowledge of relevant non-clinical notifications/guidance/guidelines in Japan/EU/US, advanced knowledge of processes for IND/NDA, intermediate knowledge of other non-clinical areas, and basic knowledge of clinical areas.
・ Experience in non-clinical areas for more than 14 years or equivalent to the experience

Skills/Capabilities

・ Intermediate presentation and negotiation skills with global mindset.
・ Intermediate communication skills in English.
・ Proven skills in managing and developing junior staff, including coaching, feedback and mentoring.

Qualification/Certificate

・ At least four-year degree required in pharmacy/veterinary science/medicine/agriculture preferably.

REPORTING RELATIONSHIPS : Group manager

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