Job Description

Document Specialist
Job Number: 21-07069
 
Be part of a company that delivers life-changing healthcare solutions. Eclaro is looking for a Document Specialist for our client in Warren, NJ
 
Eclaro’s client is a leader in the Biopharmaceutical Industry, providing quality, innovative, and affordable medicines that make a difference in the lives of patients all over the world. If you’re up to the challenge, then take a chance at this rewarding opportunity!
 
Responsibilities:
  • Supports the documentation activities for regulatory submission content and supporting documentation for cell therapy portfolio
  • Interfaces with experts in Process Development, Manufacturing Sciences and Technology, Operations, Analytical Development, Quality and Regulatory Sciences
  • Will work effectively in cross-functional project teams to accomplish company goals
  • Manage the logistical process and detailed timeline for 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 style-guides, core-templates
  • Schedule authoring, review, approval tasks and consensus meetings with stakeholders (SMEs, CMC-RA, management)
  • 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
 
Qualifications:
  • Bachelor's degree or equivalent in relevant discipline with a minimum of 5 years experience (8-10 years for senior level)
  • Familiarity with iCTD structure for regulatory submissions
  • 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
  • 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
 
If hired, you will enjoy the following Eclaro Benefits:
  • 401k Retirement Savings Plan administered by Merrill Lynch
  • Commuter Check Pretax Commuter Benefits
  • Eligibility to purchase Medical, Dental & Vision Insurance through Eclaro
 
If interested, you may contact:
John Bayog
John.Bayog@eclaro.com
6466952925
John Bayog | LinkedIn
 
Equal Opportunity Employer: Eclaro values diversity and does not discriminate based on Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status

Application Instructions

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