【ジョンソン・エンド・ジョンソン株式会社】[Janssen] R＆D, Senior Specialist/Manager, Pharmacology Group, Pre-clinical, Regulatory Affairs
仕事内容
形容
JOB SUMMARY: Briefly state the objective of this position.
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.
Focus on self-evaluation, self-management and self-development.
Educate and coach junior staff of the group.
KEY RESPONSIBILITIES: List major responsibilities and duties of the position.
- 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.
- Provide advice and/or guidance to junior staff of the group.
応募資格(必須経験など)
資格
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