This position provides electronic document publishing services (templates, formatting, proof-reading, publishing, and archiving) for regulatory documents. This position also executes and maintains processes for ACUTA Customer Regulatory submissions, correspondences, and commitments.
Location: PA & MA, United States & Bengaluru, India.
Duties and Responsibilities
- Creating Bookmarks and links as per regulatory standards.
- Perform tasks and make word documents,pdf documents submission ready.
- Develop skills on publishing and learning and using different software tools.
- Participating in Solution activities and assisting in all regulatory activities.
- Publish Regulatory submission documents to Agency, Industry and Customer defined standards (INDs, NDAs, BLAs, CTA, MAA, eCTD, NeES, etc.)
- Execute assigned activities for eCTD life-cycle document management within the document management system and the ARIM system.
- Execute, adhere to, and recommend improvements to Regulatory Operations work practices and guidelines.
- Execute Regulatory submissions quality assurance processes on electronic submission documents and the validation processes for eCTD submissions as directed.
- Required to work at onsite at a customer location when assigned.
- Bachelor/Master's degree in Life sciences, Pharmacy.
- Maters in Regulatory Affairs and equivalent is a plus.
- 1 + years of advanced user skills using Microsoft office suite and Adobe Acrobat desktop publishing techniques for regulatory submission documents are required.
- 1 + years in the pharmaceutical industry Regulatory Operations arena is desired.
- 1 + years of hands on experience with an eCTD Software System is desired.
- 1 + year of user experience within Document Management System is desired.
- Knowledge of the industry standards for desktop publishing regulatory submission documents, including Case Report Forms, to eCTD readiness is desired.
- Experience publishing Clinical Study Reports to ICH E3 standards for use in eCTDs is desired.
- General knowledge of Computer System Life Cycle Management techniques is desired.