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Job #03027

About our client Our client is a rapidly growing specialty pharmaceuticals and contract manufacturing company headquartered in Ohio. The organization has been consistently recognized by various publications as a desired place to work and they boast of both an experienced management team and a corporate culture that is focused on the long-term professional development of employees. This is a great opportunity for the right candidate. Position Location Clinical Research Associate Ohio Salary Highly competitive package, commensurate with experience Responsibilities 1) Communicate with the FDA on behalf of the company (in person, via telephone or by correspondence) 2) Notify management about interactions with the FDA by written or verbal communication 3) Interpret FD&C Acts 4) Assist in the selection of CROs to conduct clinical studies 5) Negotiate budgets and timelines for projects 6) Provide inputs and advice to various departments about interpretation and implementation 7) Interpret laws and guidelines (as applicable to company operations) 8) Examine CROs duties for conducting clinical studies (phase 1 – used to support ANDA and NDA filings) 9) Handle accounting for disposition of clinical supplies 10) Assist with development of medical and regulatory strategies to support NDA and ANDA filings 11) Collect/review the data generated 12) Assist in the preparation of medical/statistical reports and other project related documents to support submissions Requirements 1) BS (MS preferred) 2) Minimum 2 – 4 years of experience in pharmaceutical and/or clinical environment (as a CRA) 3) Experience in scientific document preparation, project management and technical review 4) Expertise in using library facilities, scientific literature searches, spreadsheets, word processing and desktop publishing 5) Experience working with the FDA to resolve questions and issues regarding clinical studies conducted to support submissions 6) Knowledge of FD&C Acts, Title 21 CFR, GCPs, FDA guidelines and other current regulations 7) Good organizational skills 8) Excellent communication, interpersonal and project management skills 9) Willingness to travel both domestic and foreign (up to 25%)