Technical writer

ICONMA; Lake Forest (IL); On-site; USD 60,000 - 80,000; Full time

Job summary

ICONMA is seeking a Specialist / Technical Writer in Lake Forest, IL, for a 4-month contract role. The successful candidate will be responsible for reviewing and writing pharmaceutical documentation, including regulatory reports and standard operating procedures, ensuring compliance with quality standards.

The position requires a bachelor’s degree, preferably in science or engineering, and experience in technical writing within FDA-regulated environments. Additional skills include excellent communication and proficiency in Microsoft Office.

Qualifications

• Bachelor's degree required in a relevant field.
• Experience in technical writing in an FDA-regulated environment preferred.
• Proficiency in Microsoft Office is necessary.

Responsibilities

• Review, edit, or develop documentation related to project timelines.
• Assist in the strategy to transition to an electronic documentation platform.
• Ensure compliance of site documents with corporate documents.
• Make recommendations for documentation content to support employee understanding.
• Travel to other company sites as needed.

Skills

Excellent communication skills

Attention to detail

Proficiency with Microsoft Office

Strong critical thinking

Problem-solving skills

Ability to work cross-functionally

Education

Bachelor's degree in science, engineering, manufacturing, or business

Tools

Microsoft Office (Excel, Word, PowerPoint)

Visio

Job description

Job Description

Specialist / Technical Writer

Location: Lake Forest, IL

Duration: 4 months

Reporting to the Remediation Manager for Quality Systems, the Documentation Specialist will review and write pharmaceutical/medical documentation—including batch records, specifications, procedures, reports, and SOPs—to provide clear and correct instructions for site processes and procedures. The role includes reviewing and assessing site documentation to ensure synchronization of content and format with corporate documentation, identifying and recommending best industry practices for documentation format, and participating in the transition from paper-based to electronic record‑keeping strategies. Responsibilities also involve identifying and providing recommended corrective actions for site documentation activities, supporting the transition to an electronic documentation platform, and collaborating with cross‑functional teams such as R&D, Quality, Manufacturing, Engineering, Regulatory Affairs, and Documentation Control.

Major Duties and Responsibilities include:

• Review, edit, or develop documentation (e.g., batch records, specifications, procedures, reports, SOPs) connected to specific project timelines.
• Assist in strategy development to transition to an electronic documentation platform.
• Review and assess site documents to ensure compliance with corporate documents.
• Make recommendations for documentation content and format to support employee understanding of batch records, specifications, procedures, and SOPs.
• Identify commonalities and linkages in different documents to optimize common remediation activities.
• Serve as an active member of the remediation team to rectify documentation gaps identified in gap assessments.
• Travel to other company sites as needed.

Qualifications

A bachelor’s degree is required, preferably with an educational background in science, engineering, manufacturing, or business to interact effectively with resources experienced in Manufacturing, Engineering, and Quality Assurance.

Experience in technical writing and/or procedure development in an FDA‑regulated environment is preferred.

Other qualifications include:

• Excellent communication skills and attention to detail.
• Proficiency with Microsoft Office (Excel, Word, PowerPoint); Visio preferred.
• Ability to organize data from multiple sources, extract key information, and write reports and summaries.
• Demonstrated ability to write logically and consistently.
• Strong critical thinking and problem‑solving skills.
• Resourceful and innovative approach.
• Ability to work cross‑functionally.

Additional Information

Experience in technical writing and/or procedure development, preferably in an FDA regulated environment. Excellent communication skills and attention to detail. Proficient with Microsoft Office (Excel, Word, PowerPoint). Visio preferred.