Assemble and publish submissions and documents that meet the requirements for publishing and working with ORA and/or regulatory agency software programs including but not limited to LiveLink, Liquent Insight Publisher (eCTD), and FDA Electronic Submission Gateway (ESG), and eSubmitter (eCOPY).
Provide eCTD publishing services on short suspense regulatory submissions to all Food and Drug Administration (FDA) reviewing divisions to include weekend and evening hours, as necessary.
Publish regulatory documents using LIQUENTSmartDesk and Adobe Acrobat Professional for CTD publishing input.
Validate regulatory submissions in eCTD format using LORENZ eValidator and InSight Validator.
Establish and comply with USAMMDA standard operating procedures for publishing, creating, providing and maintaining regulatory documents.
Monitor a central email inbox (USARMY Ft Detrick MEDCOM USAMMDA Mailbox USAMRMC REGULATORY AFFAIRS) for Food and Drug Administration communication for the intent of distribution to personnel and uploading to an electronic document management system.
Monitor regulatory submission status and ensure on time completion.
Facilitate Sponsor's signature on regulatory documentation for input to regulatory publishing process.
Test and assist in software upgrade and integration related to publishing processes including but not limited to Java, Internet Explorer, FireFox, LIQUENT Insight, LIQUENTSmartDesk, LORENZ eValidator, and InSight Validator.
Provide the ability to submit eCTD applications through the FDA electronic submission gateway (ESG) and track FDA receipt and/or acknowledgement through project completion.
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information. 41 CFR 60-1.35(c)
