Job Description

Job Description

Job Title: Senior Technical Writer

Location: Indianapolis, IN

Industry: Pharmaceutical - (Hybrid - 3 days on site; Long-term, multi-year contract)

Job Description

Theoris is assisting our client in their search for a Senior Technical Writer in a regulated pharmaceutical environment. This role is responsible for reviewing, standardizing, and governing technical and compliance documentation to ensure alignment with internal quality standards and regulatory requirements. The Senior Technical Writer will work closely under the technical direction of internal teams to clean up existing documentation, establish consistent templates and review processes, and develop compliant documentation for key SAP security initiatives. This position requires strong experience in regulated documentation, document control, and cross-functional collaboration.

Responsibilities:

• Review, assess, and inventory existing SAP BASIS and Security documentation, including tracking last review dates and identifying gaps or inconsistencies.
• Standardize documentation to align with established quality templates, formatting standards, and organizational guidelines.
• Rewrite and refine technical documentation to improve clarity, accuracy, consistency, and audit readiness.
• Develop and maintain documentation for key initiatives including Pathlock Cloud (PLC) and SAP Password and Secrets Rotation (SPARS).
• Collaborate closely with SAP, Security, Infrastructure, Quality, and Compliance teams to gather accurate technical content.
• Ensure all documentation complies with internal quality standards and applicable regulatory requirements.
• Utilize internal AI tooling (CSA Launchpad) to assist with compliance and documentation validation.
• Manage document workflows, metadata, versioning, and approvals within electronic document management systems (e.g., Veeva QualityDocs).
• Coordinate and facilitate document review and approval cycles, resolving comments and feedback from multiple stakeholders.
• Support continuous improvement initiatives related to documentation standards, processes, and writing practices.

Requirements:

• Bachelor’s degree in a scientific, health-related, technical, or communications field (or equivalent experience).
• Minimum of 5 years of experience in technical, regulatory, or medical writing within a regulated industry (pharmaceuticals preferred).
• Strong experience writing, editing, and maintaining SOPs, technical documentation, and compliance-driven content.
• Demonstrated 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.
• Exceptional attention to detail with strong organizational and document control skills.
• Proven ability to work effectively with cross-functional technical and quality teams.
• Strong written and verbal communication skills, with the ability to translate technical input into clear, compliant documentation.

Best-In-Class Benefits

We are in the people business; treating people right is our ONLY priority. Theoris Services consultants are full-time employees with full benefits, including:

• Robust Health Insurance
• 401(k) plan
• PTO accrual
• Paid holidays
• Excellent cash-based referral program

About Theoris:

Our goal is to Fuel Your Career! As a Theoris team member, you join a culture based on people-centered values and an environment that fosters both personal and professional growth. We build long-term relationships with our clients and our consultants. With over 30 years of building strong relationships in the industry, we’re uniquely positioned to make the right connections. This knowledge is used to find the right job placement. Our recruiting teams are experts dedicated to the information technology and engineering staffing space and are highly respected by our client base.

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