Validation Technical writer

07901, Summit
Oct 08, 2021
Required Education
Bachelors Degree
Position Type

TSR Consulting Services provides best in class staffing solutions to clients nationwide, by staying true to our relentless focus of exceeding the highest professional IT service business standards. Today, as a NASDAQ company specializing in IT consulting and staff augmentation, TSR continues to expand and transform its services to meet and anticipate its client’s and candidate’s’ needs. For more than 53 years, TSR's has been a leader in the industry because of our expertise and knowledge of the job market, our compassion and caring of our clients and consultants and our work environment of respect and inclusion. Your career is in good hands with TSR because at the end of the day, if YOU THRIVE, WE THRIVE.

Our client, a leading Pharmaceutical company is hiring a Technical writer on a  contracting basis.

Work Location: Summit, NJ


  • Ability to understand and define process/procedure
  • Ability to work independently and achieve pre-defined objectives
  • Critical thinking/problem solving skills
  • Excellent writing skills
  • Familiarity with FDA and EU environments and associated compliance regulations
  • Provides primary support for the organizations continuous improvement program by ensuring timely completion of document revision from a variety of inputs, including audit observations, interviews and individually driven assessment
  • Will draft, revise, review, route and approve multiple document types in an effort to ensure departmental and project milestones are met
  • Draft, revise, review route and approve Standard Operating Procedures, Work Practices, Forms, and other GMP documentation deliverables
  • Responsible for routing document deliverables through the Celgene Document Management system
  • May assist with writing deviations, CAPAs, Change Controls
  • Facilitate periodic reviews of SOPs and provide subject matter expertise in documentation best practice
  • Responsible for assisting and facilitating in requirement gathering, documenting efficient procedural solutions to varied and complex challenges
  • Attend and participate in meetings and discussions to define and capture procedures and procedural changes
  • Capture meeting notes and tasks and ensure timely distribution
  • Highly proficient computer skills in Microsoft Office Suite – Word, Excel, PowerPoint Visio and Outlook with extensive background in database systems. Innate ability to learn new software
  • Experience with technical writing and document development / generation
  • Familiarity with FDA and EU environments and associated compliance regulations
  • AA / AS degree or acceptable combination of education and practical experience
  • Minimum 3 years experience as technical writer developing procedural documentation, interfacing with stakeholders to align different and potentially conflicting needs

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