Electronic Submissions Specialist

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 successfully 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.

Reporting directly to the Director of Process Solutions within our Process Solutions Department, the Electronic Submissions Specialist’s primary responsibilities will include the following:

Solution Assessment

Document client’s readiness to produce electronic submissions
Document recommendations for client with respect to training, staffing, organizational structure, standards, processes, as well as tools and technologies
Research and document current document management and publishing solutions
Document options and evaluate assumptions, constraints, risks and benefits for various solutions
Participate in and begin to lead prototype sessions with client
Research and document client’s current document management/publishing environment and migration needs

Solution Deployment

Work with client to create processes based on business needs and available system functionality
Prepare process documentation per Octagon’s methodology
Assist with preparation and execution of user acceptance / validation-related test plans and scripts

Support

Begin to lead the preparation and delivery of role-based training materials
Track system problems and enhancements
Work with senior project team members to liaise between clients and technology vendors when troubleshooting problems

The successful candidate will have a combination of the following skills/experience:

Four year degree
Minimum of 5 + years professional experience (ideally in Pharmaceuticals and/or Consulting)
Experience in producing electronic submissions including eNDAs, eBLAs, eANDAs, eINDs and/or eCTDs
Experience in any phases of a Regulatory document management or publishing system implementation
Experience with industry leading tools such as Documentum, CoreDossier, Ezsubs, ISI Toolbox
Experience with implementing systems in a validated environment and familiar with 21 CFR Part 11
Strong writing, oral & presentation skills
Skilled in managing tasks across multiple projects
High level of client interaction requiring highly refined consulting and problem-solving skills necessary
Ability to travel 50%

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 Laurie Koch, Recruitment Manager of Talent Acquisition at lkoch@octagonresearch.com.