Document Manager

Job Juncture
Oct 18, 2016
Oct 19, 2016
Employer Type
Direct Employer
Employment Type
Full Time
Overview of the Role:
The position is responsible for execution of secure cloud based document management and control processes. Research Clinical/Regulatory secure cloud-based document management systems, choose appropriate system, drive the implementation, and assist with adoption through training and the general administrator function for accuracy and completeness. Assists in compiling Clinical, Regulatory and Quality Assurance filing documents and maintaining computerized files to support all documentation systems.
Roles and Responsibilities of the Position:
To perform this job successfully, an individual must be able to perform each essential function satisfactorily.
The individual in this position will be accountable for the following:
  • Experience with data migration to secure environment.
  • Selection of cloud based document management system, implementation and training.
  • Experience with document organization, and data migration of Regulatory and CMC documents.
  • Perform overall technical and developmental editing reviews of clinical, regulatory, and development document types, including, but not limited to, protocols, protocol amendments, clinical study reports, Investigator's Brochures, Investigational Medicinal Product Dossiers, INDs and IND amendments, briefing books, patient narratives, abstracts, and manuscripts.
  • Perform data verification and consistency/number checking tasks against approved source documents/data on above mentioned document types.
  • Perform full editorial reviews on above mentioned document types, ensuring correct grammar, mechanics, usage, style, template adherence, etc., according to company style guide and accepted standards.
  • Work with Medical Writing department and other authors to resolve issues and answer questions about style, guidance, regulations, etc.
  • Manage timelines/workload of document QC activities.
  • Perform document control quality reviews on controlled documents (e.g., SOPs, policies, forms) and department guidelines.
  • Review documents being logged within the quality document system to verify completeness, legibility, formatting, etc.
  • Assist with document control activities, as assigned, including electronic and paper logging, filing, and archiving of quality system documents; document change management; training documentation management, etc.
  • Assist with document logistics during regulatory inspections (e.g., retrieval, logging, review, notifications).
  • Other duties as assigned.

Minimum requirements:
BS/BA or higher in a relevant field.
  • At least 4 years of document QC experience in an FDA (or equivalent) regulated industry.

  • Advanced applied knowledge of the following:
  • Experience in document management system selection and implementation.
  • Experience in quality control and/or quality assurance review of regulatory submissions / aggregate reports within the pharmaceutical/regulated industry is critical, including review of documents in an eCTD system.
  • Demonstrated analytical skills and extremely high attention to detail.
  • Demonstrated strength in oral/written communication and interpersonal skills; team player
  • Demonstrated organizational skills. Experience with cloud based electronic document management systems (e.g., Veeva Vault, Documentum, NextDocs).

Company Description:

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