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3-5 years
Not Disclosed
10 March 21, 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

Technical Writer
Company: Integrated Resources, Inc. (IRI)
Location: Andover, MA
Type: Contract

Company Description:

Integrated Resources, Inc. (IRI) is a leading staffing company with a seasoned team that brings decades of experience. Since its inception in 1996, IRI has provided strategic workforce solutions to help organizations manage talent efficiently and effectively.

Job Description:

The Bioprocess R&D (BRD) organization within the Pharm Sci BTx team is seeking a Technical Writer to support document preparation, data verification, and regulatory processes.

Responsibilities:

  1. Data Verification:

    • Assist in verifying data within regulatory documents or reports.

  2. Document Tracking:

    • Track document completion and monitor data verification strategies.

    • Follow up on edits and ensure completion.

  3. Drafting New Documents:

    • Create drafts of technical or regulatory documents using templates, examples, and reports.

  4. Author Assistance:

    • Assist bioprocess team authors with assembling, formatting, and proofreading figures, tables, and content.

  5. Regulatory Documentation:

    • Prepare documents using regulatory templates in Microsoft Word and Predict.

    • Work within the GDMS document management system.

Required Skills:

  • Excellent oral and written communication skills with experience in technical writing for reports and/or regulatory documents.

  • Strong attention to detail and ability to maintain accuracy in data verification.

  • Knowledge of regulatory, GMP, or pharmaceutical environments, preferably in bioprocess or cell line development.

  • Strong interpersonal skills, ability to work independently, multitask, and collaborate effectively in a team.

  • Advanced proficiency in MS Office, particularly Word and Excel.

Background/Experience:

  • Education: Bachelor’s degree or higher in Biology, Chemistry, Biochemistry, Molecular Biology, Engineering, or a related field.

  • Experience: 3–5 years of relevant technical writing experience.