Electronic Submissions Consultant

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 Consultant’s primary responsibilities will include the following:

Electronic Submission Capability Assessment

Assess client’s readiness to produce electronic submissions (Hybrid eNDA or eCTD) using Octagon’s capability assessment methodology
Produce recommendations for client with respect to training, standards, processes, as well as tools and technologies to build internal electronic submission capabilities/infrastructure
Lead client interviews, meetings, and workshops
Identify and document areas for improvement through either system functionality or process reengineering

Technology Solution Assessment

Assist client in tool evaluations including development of requirements, Request for Proposals (RFPs), compilation of vendor evaluation feedback, and provide critical assessment of document management and electronic publishing software solutions

Capability Development

Provide EDMS subject matter expertise including best practices for document types, attributes, and folder hierarchy
Provide electronic submission publishing subject matter expertise including best practices for compilation, review, and approval
Provide document authoring subject matter expertise including MS Word templates, style guide, e-sub ready definition, and author, review, and approval processes
Work with client to create processes based on business requirements, available system functionality, and industry best practices
Develop Work Practice documents, QC checklists and/or SOPs
Prepare and deliver role-based training for EDMS, document authoring, document publishing tools, and submission publishing tools
Support system validation activities including preparation and/or execution of OQ, PQ, and user acceptance testing, as well as validation testing error analysis and resolution
Coordinate the technology production roll-out activities such as identifying initial user community, duration of initial pilot, end user support, error resolution, lessons learned workshop, etc.
Support Regulatory-related training such as history of electronic submissions, eCTD, and SPL.

Project Financials

On a routine and timely basis, track project actuals (hours/costs, expenses) to budgets
Lead development of “Change Orders” as necessary.

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

Four year degree
Minimum 8 consulting experience in the pharmaceutical, biotech industry, with a focus on Regulatory/eSubmissions and Regulatory Technology
High level of consulting experience required
Ability to manage several tasks simultaneously
Experienced team leader and mentor
Experienced in all phases of a Regulatory document management and/or publishing system implementation including, but not limited to, requirements gathering, development, deployment and support
Experienced with leading industry tools including MS Word, Authoring templates, Documentum, LiveLink, Insight, and eCTDXPress
Experience with implementing systems in a validated environment and familiar with 21 CFR Part 11
Experience in producing electronic submissions including eNDAs, eBLAs, eANDAs, eINDs and/or eCTDs
Strong writing, oral & presentation skills
Skilled in managing tasks across multiple projects
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.