Our client, a leading research intensive pharmaceutical company is looking for a qualified, experienced, and career avid regulatory affairs professional who will be functioning as a development team member.  Reporting to Chief Scientific Officer. This is a newly created position.

Qualifications:

• Bachelor degree in science, pharmacy, nursing, or related disciplines
• At least 5 year strong clinical research operation experience with US regulatory bodies
• Good project management skills involving various parties, preferably exemplified by the past experiences in working with clinical research vendors (e.g., CROs)
• Good communication and people skills
• Capable of working in a multicultural environment

Responsiblities: 

• Responsible for all operational aspects of clinical studies : clinical research A to Z operation
• Manage study budgets, timeline and resource requirements
• Manage CROs and outsourcing vendors
• Research, prepare, and update clinical protocols, instructions for use, informed consents, reports of prior investigations, bibliography, case report forms, clinical trial reports, and study-related documents
• Join in the development teams and work as a team member to provide the deliverables specific to clinical research. The development teams will consist of, but are not limited to: research laboratory, clinical research, manufacturing, and business development unit

Please email your cover letter and resume to ruth@pharmacruiting.com