Regulatory Project Manager
Octagon Research Solutions, Inc., is a fast growing Development Partnering Organization (DPO), which acts as a virtual partner in supporting its Biopharmaceutical & Pharmaceutical clients throughout the entire clinical research, development and submissions process. Based in Wayne, PA, Octagon meets their client's unmet needs by integrating information technology and multidisciplinary services to create a complete solution. We offer unparalleled practical knowledge and industry expertise that spans the clinical research and development lifecycle.
Currently, we are experiencing significant growth in our Wayne, PA office and are conducting a nationwide search in efforts to support our growth. Reporting directly to the VP of Regulatory Affairs, the Regulatory Project Manager's primary responsibilities will include the following:
- Responsible for the compilation of IND and all maintenance submissions with minimal supervision
- Assist associate directors with compiling NDA/BLA and other electronic submission
- Monitor Federal Register and disseminate appropriate information to RA and or company
- Assist Associate Directors with Regulatory searches and special projects
- Maintain a regulatory library with relevant guidelines federal register notices, ect...
- Assist Associate Directors with regulatory reviews for technical summaries and labeling
- Assist with SOP process (new SOP's and annual reviews)
- Assure submission process and standards are compliant with Octagon SOP's
- Create and maintain templates for administrative documents that are frequently requested by clients (patent certification, list of investigators, debarment statement, ect)
- Will represent Regulatory Affairs at routine project meetings and teleconferences.
The successful candidate will have a combination of the following skills/experience:
- Bachelor's Degree (preferably in a scientific discipline)
- 5 Years related industry experience (or Masters degree with 2-4 years experience) with an emphasis in Regulatory Submissions
- Must have good understanding of submission compilation and application requirements and applicable regulations
- Must be proficient in performing document reviews and QA checks
- Must be customer oriented
Octagon is an Equal Opportunity Employer with an outstanding corporate culture. We are an emerging growth company providing a business casual environment, strong benefits, competitive compensation and outstanding career advancement opportunities. The entrepreneurial setting, coupled with our financial stability, has made us an employer of choice, and one of the most sought after Life Sciences employers in the area. Please visit us at www.octagonresearch.com to learn more about how we are revolutionizing the drug development lifecycle.
To apply, please forward your resume to Chris Kane, Recruiting Specialist at ckane@octagonresearch.com.
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