Regulatory Bioprocess Technical Writer (GMP/Pharma)

Artech Information System LLC; Andover (MA); On-site; USD 45,000 - 60,000; Full time

Job summary

A leading IT staffing company is seeking a detail-oriented individual to assist with regulatory documents and reports. The ideal candidate will have excellent communication skills and experience in technical writing, particularly in the pharmaceutical or bioprocess areas. You will support R&D teams, create regulatory drafts, and utilize document management systems. This position is primarily based in Andover, MA, with flexibility for Chesterfield, MO as a secondary location.

Qualifications

• Experience in technical writing of reports and regulatory documents.
• Regulatory, GMP or Pharmaceutical experience in bioprocess or cell line development is desirable.

Responsibilities

• Assist with verification of data within regulatory documents or reports.
• Support the bioprocess R&D teams in tracking document completion and data verification strategies.
• Create drafts of new technical or regulatory documents using templates or reports.
• Assist Bioprocess team authors in assembling and proofreading figures and tables.
• Prepare documents using Regulatory templates in Microsoft Word.

Skills

Excellent oral and written communication

Detail oriented

Tools

Microsoft Word

GDMS document management system

Job description

A leading IT staffing company is seeking a detail-oriented individual to assist with regulatory documents and reports. The ideal candidate will have excellent communication skills and experience in technical writing, particularly in the pharmaceutical or bioprocess areas. You will support R&D teams, create regulatory drafts, and utilize document management systems. This position is primarily based in Andover, MA, with flexibility for Chesterfield, MO as a secondary location.