Documentation Analyst

Company: Alpha Consulting Corp.
Location: Warren
Posted on: May 23, 2023

Job Description:

DOCUMENTATION ANALYST


Remote.



Project Description:

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• Technical Writing and Document Management (TDM) function is responsible for delivering CMC documentation (Dossier and supporting documents) to support regulatory strategy for Cell therapy portfolio from early stage through life cycle management.
  
• Document Specialist supports the documentation activities for regulatory submission content and supporting documentation for cell therapy portfolio.
  
• This role requires effective collaboration across technical functions to deliver on timelines for submissions. The position interfaces with experts in Process Development, Manufacturing Sciences and Technology, Operations, Analytical Development, Quality and Regulatory Sciences.
  
• The successful candidate will work effectively in cross-functional project teams to accomplish company goals.
  
  
  
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  • Manage the logistical process and detailed timeline for CTD Quality sections aligned with scientific/regulatory content creation for clinical, commercial, and life-cycle CMC regulatory submissions and responses to health authority questions.
    
  • Assist with dossier creation and system compliance for regulatory submissions.
    
  • Manage dossier content and agency questions delivery timelines aligned with global CMC submission timelines.
    
  • Must possess a thorough understanding of the source documentation requirements needed for regulatory submissions and the correlation to the authoring process.
    
  • Support SMEs with document editing for compliance with the Client authoring style guide, Core template.
    
  • Schedule authoring, review, approval tasks and consensus meetings with stakeholders (SMEs, GRS CMC, management).
    
  • Facilitate data verification activities.
    
  • Participate in initiatives involved with regulatory filings.
    
  • Participate in various cross-functional project teams, interact with SMEs, regulatory and other key partners both internal and external to the company as necessary.
    
  • Must possess the ability to support multiple projects simultaneously.
    
  • Work in a team environment and foster teambuilding for the improvement of processes and enhancement of productivity to align with key business drivers.
    
  • Demonstrate commitment to excellence and bring a high energy level to daily activities as well as involve periods of high intensity work under tight timelines.
    
  • Works independently under supervision and collaborates with other teams.
    
  • Trains others on procedures as appropriate.
    
    
    
    Required Skills:
    
    
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    • Bachelor's degree or equivalent in relevant discipline with a minimum of 2 years' experience (4-7 years for senior level).
      
    • Familiarity with eCTD structure for regulatory submissions is required.
      
    • Outstanding verbal and writing communication skills, attention to detail, strong planning, organizational and negotiating skills, with focus on timely delivery.
      
    • Proficiency in commonly used applications like Word/Excel is required. Documentum experience is preferred.
      
    • Experience with regulatory documentum software is required along with proficiency in compliance ready standards for final publication is a strong asset.
      
    • Must be capable of working in a fast-paced changing team environment, prioritizing multiple tasks to meet filing deadlines.
      
    • Possess strong interpersonal skills and demonstrate ability to effectively interact with business functions.
      
      
      
      This 6+month position starts ASAP.
      
      
      
      Please E-MAIL your resume (attachment to email) with rate and availability to Malika:
      
      
      
      ALPHA'S REQUIREMENT #23-00766
      
      MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE

Keywords: Alpha Consulting Corp., Elizabeth , Documentation Analyst, Professions , Warren, New Jersey