Hybrid Senior Technical Writer – Regulated Pharma

CDL Labor Logistics; Indianapolis (IN); Hybrid; USD 90,000 - 135,000; Full time

Benefits offered by this job

Health Insurance

401(k) plan

PTO accrual

Paid holidays

Referral program

Job summary

Theoris is seeking a Senior Technical Writer in Indianapolis, IN, to govern and standardize regulated documentation for SAP security initiatives in a validated pharmaceutical setting.

In this role you will rewrite and refine technical content, maintain templates, and ensure audit readiness while collaborating with SAP, Security, Infrastructure, Quality, and Compliance teams. Experience with Veeva QualityDocs is required.

Qualifications

• Bachelor’s degree in scientific, health-related, technical, or communications field or equivalent experience.
• Minimum 5 years of technical, regulatory, or medical writing in a regulated industry (pharmaceuticals preferred).
• Experience writing, editing, and maintaining SOPs, technical documentation, and compliance-driven content.
• Understanding of regulatory and quality requirements, including FDA and ICH guidelines.
• Hands-on experience with electronic document management systems such as Veeva QualityDocs or similar platforms.

Responsibilities

• Review and inventory SAP BASIS and Security documentation and identify gaps.
• Standardize documentation to quality templates and guidelines.
• Rewrite and refine technical documentation for clarity, accuracy, and audit readiness.
• Develop documentation for initiatives like Pathlock Cloud (PLC) and SAP Password and Secrets Rotation (SPARS).
• Collaborate with SAP, Security, Infrastructure, Quality and Compliance teams to gather content.
• Ensure compliance with internal standards and regulatory requirements.
• Utilize internal AI tooling to assist with compliance and validation.
• Manage workflows, metadata, versioning, and approvals in EDD systems (e.g., Veeva QualityDocs).
• Coordinate document review and resolve stakeholder feedback.
• Support continuous improvement of documentation standards and processes.

Skills

Technical writing

Regulatory writing

SOP writing

Cross-functional collaboration

Attention to detail

Document control

FDA ICH guidelines

Veeva QualityDocs

Education

Bachelor’s degree in scientific field

Tools

Veeva QualityDocs

Job description

Theoris is seeking a Senior Technical Writer in Indianapolis, IN, to govern and standardize regulated documentation for SAP security initiatives in a validated pharmaceutical setting.

In this role you will rewrite and refine technical content, maintain templates, and ensure audit readiness while collaborating with SAP, Security, Infrastructure, Quality, and Compliance teams. Experience with Veeva QualityDocs is required.