Documentation Specialist

Purpose: The Document Specialist will be responsible for the assembly and publishing of complex clinical and non-clinical documents in support of US based programs. They will perform quality control of clinical and non-clinical regulatory documents, including but not limited to Clinical Study Reports, CTD Summaries, Investigator Brochures, and responses to Regulatory Agencies. They will be responsible for ensuring regulatory documents comply with regulatory and company guidance/template specifications with respect to format, structure and presentation. They will develop and maintain relationships with key individuals in the three R&D sites to ensure on time delivery of submission ready documents and dossiers of the highest quality.


ESSENTIAL DUTIES AND RESPONSIBILITIES
-Responsible for the secure receipt, storage, tracking and retrieval of submission documents.
-Responsible for making submission documents ?submission-ready? in PDF format (eg, post-PDF processing activities).
-Provide leadership, management and training to ensure excellent standards of quality for regulatory documents (i.e., accuracy, completeness and in accordance with submission standards).
-Work with Medical Writing, Regulatory Affairs and Clinical Research departments to implement quality control checks to ensure all information and data provided are accurate, complete and meet regulatory document specifications.
-Assist with the development and implementation of streamlined processes to facilitate department's software application use, assist with compilation, production and distribution of submissions.



QUALIFICATIONS:
-2-5 years experience in clinical/regulatory document publishing/management.
-Experience with preparing document templates.
-Proficiency in high-level copy editing, proofreading, and formatting is a plus.
-Familiar with electronic document management and publishing systems.
-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 neededClassification: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, Investigator Brochure, REGULATORY AFFAIRS, Clinical Study Reports, REGULATORY DOCUMENTS, CLINICAL SUBMISSIONSContact Information
Contact:Griffin,Matthew E