Job Description

Technical Writer
Job Number: 21-05539
 
Be part of a company that delivers life-changing healthcare solutions. Eclaro is looking for a Technical Writer for our client in Summit, 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:
  • Preparation, review and/or QC of documents for nonclinical drug metabolism and/or bioanalytical within Client Nonclinical Disposition and Bioanalysis (NDB)
  • Review data to determine the appropriate tabular and textual formats, and the clarity, logic and order of presentation
  • Work with scientists in NDB to ensure proper presentation of data
  • Follow internal guidelines for document preparation
  • Follow templates for nonclinical documents that are consistent with FDA and ICH guidelines and with electronic submissions guidelines
  • Participate in meetings and assist in resolving issues related to document preparation
  • Work with NDB Document Specialist and Regulatory Operations department to contribute to the authoring, review, and approval process for electronic documents
  • Facilitate document review meetings and discussions
  • Review work of other writers for accuracy, quality, and adherence to format and stylistic requirements
  • Other duties/responsibilities as assigned
 
Qualifications:
  • Excellent technical writing and verbal communication skills
  • Proficiency in use of Microsoft Word, Excel, data graphics software, Adobe Acrobat, and web-based browser software to manage electronic document authoring, reviewing, and approval process
  • Ability to work with multiple complex projects and within cross-functional teams
  • BA/BS/MS degree with 3+ years experience in drug metabolism, pharmacokinetics, bioanalysis or as a technical writer
 
Preferred Qualifications:
  • Experience with Investigational New Drug (IND), New Drug Application (NDA), and/or Common Technical Documents (CTD) and electronic document submissions (eCTD) for Food and Drug Administration (FDA) submissions, and nonclinical & regulatory documents with registration dossiers
  • Familiarity with techniques of chemistry, pharmacology, pharmacokinetics, and/or toxicology and first-hand laboratory experience
 
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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