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[Janssen] R&D, Manager, Regulatory Affairs Div. Pre-clinical Dept. Pharmacology Group

Auris Health

Auris Health

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Japan
Posted on Wednesday, July 19, 2023
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Description

JOB SUMMARY

  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

  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.

Qualifications

REQUIREMENTS

 Experience/Knowledge

    ・Expert knowledge of the non-clinical area, advanced knowledge of relevant nonclinical 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.

Johnson & Johnson Family of Companies in Japan strongly recommends prospective employees to complete the COVID-19 vaccination before or as soon as after joining our company to prevent the spread of infection among our employees and people around them as well as our customers and the community we serve, and to ensure our responsibilities are sustainably fulfilled as a healthcare company (except for those who cannot vaccinated with underlying medical conditions and other circumstances).

This job is no longer accepting applications

See open jobs at Auris Health.