Clinical Research Associate- Japanese Development

Job Description:Alcon, Inc. is the world's leading eye care company with sales of $5.6 billion in 2007. The company's nearly 13,000 employees worldwide, work in 75 facilities around the world to research, develop, manufacture and sell eye care products in more than 180 countries. Alcon is the largest specialty eye care company in the world and leads the growing $14.5 billion market for eye care products. Alcon has delivered strong and stable growth for over 60 years, and it is positioned to build on this record in the years to come. For ten consecutive years, Fortune magazine has selected Alcon as "One of the 100 Best Companies to Work For". Alcon's U.S. Operations is headquartered at its 300-acre campus located in Fort Worth, Texas. For more information on Alcon, Inc., visit the Company's web site at .General Description: The incumbent will be responsible for initiating, monitoring, completing and reporting on clinical studies conducted on assigned projects within R&D, Japan Development; conducting GCP studies with end result/goal being to produce reliable, accurate data to support Japanese applications such as CTNs, J-NDAs and submission materials for PMDA consultation meetings; collaborating with Alcon R&D US and Japanese functions in preparing responses to MHLW/PMDA instructions and clinical sections of Japanese documents such as Protocols, CIBs, and CTDs (e.g. NDAs, STEDs); interfacing heavily with Global clinical personnel, relevant R&D functions and Japan regulatory personnel to reach Japan's target objectives in strategic project planning efforts; reviewing CIBs and protocols written by clinical teams in Japan and to justify design strategy to FTW colleagues when carrying out the review and approval process; and preparing for Alcon headquarter and clinical site audits by MHLW auditors and succeeding at defending data during PMDA GCP Inspections in domestic or overseas environment and capacity.Minimum Qualifications: * Incumbent must be able to read and speak Japanese * Master's degree with up to 3 years related experience* Bachelor's degree in an appropriate discipline and at least 3 years related experience* R.N. certification with a minimum of 6 years clinical research experience including 3 years of direct CRA experience Our generous benefits package includes the Alcon 401(k) Plan which matches employee contributions up to 5% of eligible pay at the rate of $1.00 for each dollar contributed, and the Alcon Retirement Plan (ARP), a qualified plan in which Alcon contributes 7% of eligible pay to the accounts of all eligible employees. By combining the Company's contributions to the 401(k) and ARP, employees can receive up to 12% of eligible pay from Alcon towards retirement. Alcon also offers medical, dental, vision, life and disability coverage, an on-site fitness center and much more. Consider having all this in a fast paced environment within a stable world-class organization.Alcon is an Equal Opportunity Employer committed to quality through diversity. M/F/D/V. Pre-employment drug testing.Click here to submit your resume via the Alcon Careers portal.Expected Travel Time: None