eCTD Specialist needed for Medical Client (closed)
This IT position will support our company*s regulatory information systems and processes used by Regulatory Affairs and R&D Publishing for planning, preparation, publishing, transmission, and tracking of regulatory submissions. Company*s submissions include eCTD, NeeS, INDs, and Technical Files, electronic and paper, and are filed globally.
Responsibilities would include:
* End-user support - troubleshooting problems, managing client software (inventory, configuration, and testing). Business side system administration of regulatory systems and tools including, but not limited to: Regulatory Electronic Document Management System; eCTD authoring templates; document publishing tools; eCTD publishing/validation review tools; Regulatory web collaboration sites and Regulatory file shares.
* System support -Management of system change control process including evaluating vendor maintenance releases, tracking and reporting system issues and bugs while closely interacting with the business lead, IT, IT PM, QA, and vendor technical and product support to identify and implement solutions. Also includes analyzing system and process inefficiencies, identifying optimal solutions, and ensuring identified solutions are successfully implemented.
* System administration for account and access maintenance, reference data maintenance and usage reporting.
* Project manager or business analyst for projects to define requirements for, select, and implement new software systems and tools that support the Regulatory Affairs business area.
* Maintain expert knowledge of industry guidance, regulations, and trends with respect to system validation (21CFR part 11) and electronic submissions (eCTD, RPS, SPL, PMM).
Desirable experience includes working with document management systems or electronic regulatory submissions (eCTD), working with validated applications, and R&D experience at a pharmaceutical or medical device company. Desirable software skills include Adobe Professional, Documentum, WORD, Liquent Insight Publisher and Insight Manager.
Key skills and experience desired:
* Expert knowledge of eCTD
* Familiarity with Insight Publisher and eCTD validation review tools a plus
* Application support, administration, integration, and implementation
* Project Management Experience
* Life Sciences Industry
* Excellent organization, time management and communication skills.
Minimum Education Requirements: Associate's degree with emphasis on computer science or information technology OR Bachelor's degree in information systems, business administration, computer science, or a technical field.
Minimum Experience Requirements: Associate's degree with 8 years internal experience, or 9 to 11 years external experience and direct applicability to position accountabilities OR Bachelor's degree with 8 to 10 years in an information technology related position.
Relocation Assistance Available