Instagram
youtube
Facebook
3-5 years
Not Disclosed
10 April 28, 2025
Job Description
Job Type: Full Time Education: BS Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Technical Writer
Location: Andover, MA
Employment Type: Contract


Company Overview:

Integrated Resources, Inc. (IRI) is a workforce solutions provider, delivering strategic services to efficiently manage talent and business operations. Established in 1996, IRI has built a strong team of experts, expanding into new sectors and achieving steady growth over the years.


Position Summary:

The Technical Writer will join the BRD organization within the Pharm Sci BTx division. This role involves assisting with the creation and verification of technical and regulatory documents, ensuring accurate data and compliance with regulatory standards.


Key Responsibilities:

  • Document Verification and Editing: Assist in the verification of data within regulatory documents and reports, ensuring accuracy and completeness.

  • Bioprocess R&D Support: Track document completion, collaborate with teams to finalize data verification strategies, and assist in completing edits.

  • Document Drafting: Create drafts of new technical or regulatory documents using existing templates and examples.

  • Content Assembly: Work with Bioprocess team authors to assemble, format, and proofread figures, tables, and other content for documents.

  • Document Management: Prepare documents using Regulatory templates in Microsoft Word, and work within the GDMS document management system to ensure proper storage and retrieval.


Qualifications and Skills:

  • Education: BS or higher in Biology, Chemistry, Biochemistry, Molecular Biology, Engineering, or similar.

  • Experience: 3–5 years of experience in technical writing, particularly in the preparation of reports or regulatory documents. Regulatory, GMP, or Pharmaceutical experience in bioprocess or cell line development areas is desirable.

  • Skills:

    • Excellent oral and written communication skills.

    • Detail-oriented with strong organizational skills.

    • Ability to work independently and manage multiple tasks efficiently.

    • Strong interpersonal skills and a team player.

    • Advanced proficiency in Microsoft Office.