北京招聘

PURPOSE
Prepares and/or reviews regulatory submissions to support clinical trial and marketing authorisation activities for either internal and/or external clients. With guidance from senior staff, provides regulatory support for more complex projects.

RESPONSIBILITIES
? Acts as a Regulatory Team Leader on more complex projects, which may include technical writing.
? Prepares and/or reviews regulatory documentation in area of expertise, as appropriate.
? Establishes relationships with many customers; may meet face to face without rest of the team to discuss regulatory issues, present lessons learned and discuss customer comments.
? Understands the Scope of Work, deliverables and management of budget for any given project and manages workload as appropriate.
? May give guidance to junior colleagues, including feedback on the quality of technical documents, and may assist in their training and development.
? May present to clients on complex regulatory processes at large full service bid defence meetings by phone or in person.
? May act as reviewer for regulatory SOPs, as assigned and appropriate.
? May prepare and deliver regulatory training to Quintiles small groups or individuals.
? Performs other tasks or assignments, as delegated by Regulatory management.

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
Possesses a specific regulatory or technical expertise
Good, solid interpersonal communication (oral and written) and organisation skills
Strong software and computer skills, including MS Office applications
Demonstrates self-motivation and enthusiasm
Demonstrates negotiation skills and is confident in making decisions with minimal supervision
Ability to work on several projects, retaining quality and timelines
Ability to follow SOPs consistently; provides independent thought to assist in process improvements

MINIMUM REQUIRED EDUCATION AND EXPERIENCE
? Degree in life science-related discipline or professional equivalent plus at least 3 years relevant experience

ABOUT THE COMPANY
Quintiles Transnational Corp. strives unceasingly to exercise strong LEADERSHIP in our industry and to be the unquestioned FIRST CHOICE Contract Pharmaceutical Organization in an increasingly competitive marketplace.
We will DELIGHT our CUSTOMERS world-wide with the fullest range and highest quality of information and services, and with a spirit and a DEDICATION that bring professional esteem and admiration.
We demand the utmost level of EXCELLENCE, CREATIVITY, and SKILL from all our staff and management so that we add value to our customers by driving to PERFORMANCE goals in ways that are quantifiable.
We thrive on continuous IMPROVEMENT and QUALITY enhancements through attention to detail,consistent feedback, state-of-the-art systems, TRAINING and TEAMWORK.
We seek unendingly to bring our customers'PRODUCTS and SERVICES to MARKET ever sooner and to play a creative role in their achievement of earlier and greater commercial SUCCESS.
Throughout our commercial pursuits, we will respect and hold in esteemed honor our EMPLOYEES, to whom we owe our very existence.
We will maintain and enhance our reputation and integrity by demanding the highest possible ETHICAL STANDARDS and demonstrate by example an unyielding dedication to employees, customers, vendors, and shareholders. A SHARED VISION of success among these stakeholders will enhance the quality of life for all people of the world as we vigorously pursue our mission in an era of unprecedented OPPORTUNITY