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Senior Specialists and Specialists

(eCTD and CTD Submission Managers)

Octagon Research Solutions is seeking candidates with in-depth knowledge of electronic submission regulatory guidances as well as a thorough understanding of the submission lifecycles and drug development. Attributes of successful candidate include the following:

  • Four (4) plus years of experience in electronic submissions and with eCTD
  • One (1) plus years of experience in Project Management or in a Team Lead role
  • Knowledge of publishing software and tools used throughout the industry
  • Excellent communication skills as a key contact for clients and publishing team
  • Self-motivated individuals with initiative and an ability to work in a fast paced, high volume environment

Octagon's Regulatory Services include professional consulting, submission outsourcing, expert training and business process outsourcing for the entire submission lifecycle. Octagon's Regulatory Affairs and Regulatory Operations team is composed of accomplished professionals who came from industry. They offer significant domain expertise that includes production and maintenance of electronic and paper submissions, development of strong agency relationships and the integration of technology into regulatory processes.

The Specialist's primary responsibilities will include the following:

  • Control submission content, being accountable for the receipt and workflow completion of all submission components, resulting in a high quality final product.
  • Conduct issue resolution, communicating with the client and their functional areas to ensure that all issues are resolved in a compliant manner.
  • Regular communication with the client, including, but not limited to, face-to-face meetings, presentations, telephone, email, and conference call interaction.
  • Work with the Manager to develop milestones and timelines, to relay these objectives to the team, and to ensure that the team is successful in obtaining these goals.
  • Ensure that the team follows, and strictly adheres to, internal standards including Standard Operating Procedures, Guidance Documents, and Policies throughout the lifecycle of the submission.
  • Ensure that Specific Project Specifications, if they exist, are strictly adhered to throughout the lifecycle of the submission.
  • Keep the project within budget by properly managing resources.
  • Responsible as the team leader for becoming a role model to the entire publishing team.
  • Ability to travel and deploy without extended notice.

Octagon is an Equal Opportunity Employer with an outstanding corporate culture.  Please visit us at http://www.octagonresearch.com/ to learn more about how we are revolutionizing the drug development lifecycle. 

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