崗位職責:
Job Description:
1.Responsible for the management and implantation of the clinical product development and regulatory strategy, including, either by direct generation or through professional service providers, but not limited to
2.Oversee the clinical direction, medical planning, execution and medical interpretation of clinical trials
3.Establish and approve scientific methods for design and implementation of clinical protocols, data collection systems and final reports
4.Develop strategic clinical relationships with physicians, vendors, business contacts, external experts and/or relevant scientific organizations, either directly or through clinical operations
5.May recruit clinical investigators and oversee or negotiate study budgets and contracts
6.Coordinate and develop information and documents for regulatory authorities
7.Coordinate and develop information and presentations for senior management, clinical collaborators and/or other groups
8.Contribute to preparation of a variety of corporate and regulatory clinical documents
9.Attend high-level national and international medical meetings
10.Participate in communication (i.e. publication, abstracts)
11.Ensure each project to be conducted according the state of the art quality systems (e.g. internal quality management system, GCP ICH, etc). The latter may include generation, maintenance and management of relevant standard operating procedures
任職資格:
Job Requirements:
1.Doctor of Medicine is required
2.At least 10 years of experience in clinical development and regulatory affairs in the pharmaceutical/biotech industry
3.Knowledgeable and experienced in interpretation of regulations and guidelines related to drug development
4.Capable of strategic thinking and proposing innovative solutions to regulatory problems
5.Hands-on experience in clinical study design and conduct, Experience with original IND, BLA or NDA in eCTD formatted submissions
6.Good working knowledge of Mircosoft Office. Experience in GCP ICH is required
7.Fluent written and spoken English, Chinese and French language would be preferred
8.Demonstrate excellent teamwork and communication skills with ability to impact and influence the decisions of a team
9.Flexible, mature, self-motivated, independent and able to work under pressure. Organized, rapid and with special attention to details. Open-minded, working well in a team as well as with external contacts (i.e. external consultants and professional service providers, regulatory agency personnel). Have good communication and presentation skills, Willingness to travel
Location: Tianjin

天士力控股集團于1994年5月成立，2002年8月，集團所屬核心企業——天士力制藥股份有限公司上市。公司成立十五年來，堅持自主創新，走新型工業化的發展道路，全力打造大健康產業第一品牌，全面推進國際化。形成了以“生命安全保障產業”為主線，包括現代中藥、化學藥、生物藥、特色醫療等產業；以“生命健康需求產業”為拓展，涵蓋保健品、化妝品、健康食品、安全飲用水等領域的高科技跨國企業集團。