Logo
Katalyst CRO

Katalyst CRO is hiring: Technical Writer in Exton

Katalyst CRO, Exton, Chester County, United States

Save Job

Join to apply for the Technical Writer role at Katalyst CRO

3 days ago Be among the first 25 applicants

Join to apply for the Technical Writer role at Katalyst CRO

Get AI-powered advice on this job and more exclusive features.

  • Author technical reports, policies, and Standard Operating Procedures.
  • Author/review, format, and revise reports, protocols, analytical method validations, and CMC sections for regulatory submissions.
  • Author investigations, deviations, change controls, and other non-conformance records.
  • Work with vendors to coordinate testing and arrange shipments as needed.
  • Compile and review scientific data for completeness as needed.
  • Perform trending and evaluation for continuous monitoring of stability data and shelf-life extension.
  • Use of LIMS database including protocol setup, data entry/approval, and data trending.
  • Process invoices, purchase orders, and other agreements. Interact with finance and vendors to confirm work and adjust budget forecasts.
  • Coordinate document review, approval, and archiving.
  • Participate in analytical testing lab activities, on an as needed basis.

Responsibilities

  • Author technical reports, policies, and Standard Operating Procedures.
  • Author/review, format, and revise reports, protocols, analytical method validations, and CMC sections for regulatory submissions.
  • Author investigations, deviations, change controls, and other non-conformance records.
  • Work with vendors to coordinate testing and arrange shipments as needed.
  • Compile and review scientific data for completeness as needed.
  • Perform trending and evaluation for continuous monitoring of stability data and shelf-life extension.
  • Use of LIMS database including protocol setup, data entry/approval, and data trending.
  • Process invoices, purchase orders, and other agreements. Interact with finance and vendors to confirm work and adjust budget forecasts.
  • Coordinate document review, approval, and archiving.
  • Participate in analytical testing lab activities, on an as needed basis.

Requirements:

  • BS in Chemistry, Biology or a related scientific discipline.
  • At least 2-3 years scientific/analytical lab experience, preferably in the field of protein therapeutics or monoclonal antibody therapies.
  • Proficient in scientific/technical writing.
  • Experience in Empower chromatographic data system.
  • Experience with LIMS, SAP/SRM, Track Wise, and Veeva.
  • Excellent oral communication, interpersonal and technical writing skills.
  • Excellent organizational skills, demonstrate attention to detail.
  • Experience in GMP/GLP and/or a regulated industry.
  • Strong background in Microsoft applications such as Word, Excel, SharePoint a must.
  • Advanced Excel knowledge is a plus.

Seniority level

  • Seniority level

    Associate

Employment type

  • Employment type

    Contract

Job function

  • Job function

    Information Technology

  • Industries

    Pharmaceutical Manufacturing

Referrals increase your chances of interviewing at Katalyst CRO by 2x

Sign in to set job alerts for “Technical Writer” roles.

Marketing Content Editor - Footnote Indication

Marketing Communications Manager/Copywriter

Associate Scientist/Medical Writer- Content Digitization

Technical Writer - Pharmaceutical Manufacturing

Technology Learning & Development Technical Writer

Wilmington, DE $85,000.00-$95,000.00 1 day ago

Full Time Nabisco Merchandiser/Order Writer

We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.

#J-18808-Ljbffr