Submission Publisher

Purpose: JOB SUMMARY: The Submission Publisher will be responsible for the build, delivery, and archival of paper and electronic submissions for all programs in the US. The associate will be accountable for publishing high quality regulatory submissions including, INDs, eCTDs, NDAs, BLAs, supplements and amendments.


ESSENTIAL DUTIES AND RESPONSIBILITIES
-Manage, coordinate, build and dispatch submissions to Regulatory Agencies in compliance with the appropriate regulations and guidance?s.
-Provides leadership and expertise in the development of worldwide submissions for the optimal assembly, archival and presentation of submissions to regional regulatory authorities.
-Assist with the definition, development, and implementation of global publishing and records management policies and procedures.
-Participate in IT projects and system validations related to regulatory publishing.
-Assist with Training of personnel in the R&D organization in the US.


QUALIFICATIONS:
-2-5 years of document management and publishing experience.
-Substantial experience in filings of INDs, NDAs, ANDAs, BLAs preferably in CTD format or eCTD format.
-Knowledge of IND, NDA, MAA, CTD requirements and guidelines.
-Outstanding negotiation skills.
-Demonstrated ability to work within a cross functional team and a matrix environment.
-Ability to travel as needed.Classification:Direct PlacementCompensation:
BOE YearJoin Aerotek Scientific LLCSM, one of the fastest growing providers of scientific and clinical research services in the nation. Due to our growth, we're constantly on the lookout for qualified professionals to place in contract, contract-to-hire, and permanent placement positions across the scientific and clinical research communities. At Aerotek Scientific, we know it's more than just your day-to-day responsibilities that can make or break a job. It's the support you get. That's the reason Aerotek Scientific offers a variety of benefits including medical, dental, optical, 401k, and many more. Don't put your career in the hands of just anyone, put it in the hands of a specialist. Join the Aerotek Scientific team! Allegis Group and its subsidiaries is an equal opportunity employer.

Required Qualifications:
Skills Requirements:
IND, NDA, REGULATORY AFFAIRS, Regulatory GMP/ GLP, CLINICAL SUBMISSIONS, GCP/ ICHContact Information
Contact:Griffin,Matthew E