Global Regulatory Consulting Director / 大手外資CRO
|職種||Global Regulatory Consulting Director|
Responsible for leadership of major assignments and client relationships. In consultation with the line manager responsible for organizing and managing project teams and for the quality and timeliness of assignments. Provides advice and assistance to clients and other associates in areas of expertise. Ensures that the various project related tasks are completed in conformity with all Company policies Standard Operating Procedures and governmental regulations. Contributes to business development for regulatory functions.
1.Contributes to planning for GRC function in assigned region/country.
2 Responsible for day to day management of projects
3.Acts as a representative of the regulatory department with other departments.
4.Supports business development including generation of repeat business from existing clients and proposal development.
5.Develops reviews and monitors project budgets; reviews client invoicing.
6.Monitors personal utilization and utilization of direct reports.
7.Acts as a key point of contact for clients and regulatory authorities.
8.Provides regulatory advice to Company associates.
9.Conducts regulatory research on projects as needed.
10.Provides strategic and operational advice to clients.
11.Arranges leads and reports on client and regulatory agency meetings.
12.Writes clinical trial and product registration dossiers clinical reports and other medical documents. Manages project teams and preparation of regulatory submissions for conduct of clinical trials product registration and post approval maintenance activities.
13.Acts as a resource for technical knowledge.
14.Participates in quality improvement efforts to increase overall operational efficiency.
15.Contributes to the building of regulatory systems and infrastructure needed for GRC
16.Develops reputation for the Company as industry leader in Regulatory by attending and speaking at industry events such as seminars association meetings authoring articles for trade journals and participation in industry association through memberships and on committees.
17.Develops solutions to complex problems.
18.Provides internal training in appropriate areas of expertise to other departments.
Performs other work related duties as assigned:
Responsible for day to day management of project teams and projects. Line management responsibilities for staff members. For d
BS degree preferably in a science related field or equivalent experience in science/regulatory/medical writing related field. Moderate pharmaceutical/medical device related experience. Moderate experience in regulatory. Demonstrated experience in contributing to the preparation of regulatory submissions including electronic submissions. Experience working in an independent office environment and in a complex multi process oriented environment in general preferred. Comprehensive regulatory knowledge and understanding of pharmaceutical and or medical device product development. Excellent customer service and interpersonal skills with the ability to work both as a team member and independently. Excellent written and verbal communication skills. Good quality management and budgeting skills. Good people management project management problem solving and decision making skills. Computer literacy in MS Word Excel and PowerPoint. Ability to interact with staff from multiple departments and offices to establish project standards. Good initiative adaptability and pro activity. Good attention to detail flexibility and open to suggestions.
|年収||1400万円 - 1700万円|