Entry level / Recent College Graduates - detail oriented, computer smart, motivated

Electronic Submissions Associate

 

We are seeking candidates that have good communications skills and good computer skills.  Candidates should be detail oriented, have a desire for growth, and have a desire to be part of the pharmaceutical industry. The attention to detail is vital. There is opportunity for rapid advancement within the group, making this a great entry level opportunity.  Attributes of successful candidate include the following:

 4 year degree or equivalent work experience Flexible and adaptable to changing situations both within a team and from team to team, as well as changes in Industry, Agency or technology. Ability to communicate as part of a team; strong written and oral communications Understanding and basic experience in MS Office tools, Acrobat, and Windows; comfortable with technology Motivated and takes initiative High level of attention to detail Seeks growth and a career

Octagon Research Solutions, Inc. is a fast growing Development Partnering Organization (DPO), based in Wayne, PA, which acts as a virtual partner in supporting its Biopharmaceutical & Pharmaceutical clients throughout the entire clinical research, development and submissions process.

 

The Regulatory Operations Department is our largest department – and one of our fastest growing. This high-energy department promotes most of their leaders from within. The department has a lot of camaraderie, a strong sense of quality, and most of all: they have fun while they work hard.

 



Under the direction of a Project Lead, this position is responsible for basic electronic submission tasks including image QA, transformation/concatenation, bookmarking, hyperlinking, and document level -QC of regulatory documentation for submission to the FDA or other regulatory agencies. Training will be provided. Responsibilities include the following: 

 Image Quality Control and/or Quality AssuranceUse of Microsoft Office programsUse of Internal and External Publishing ToolsFollow all Internal standards including: Standard Operating Procedures, Guidance Documents and Policies throughout the submission lifecycle.Responsible for reading and learning external guidance documentation related to electronic submissions such as FDA Guidance documents or ICH guidance.  Completion of assigned tasks with a high degree of quality in a timely mannerScanningBe prepared to deploy on-site to support electronic submission projects.Customer/ Client Services experienceAbility and willingness to travel



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 http://www.octagonresearch.com/ to learn more about how we are revolutionizing the drug development lifecycle.



To apply, please forward your resume to Jane L. Huang, Senior Recruiting Associate at jhuang@octagonresearch.com