Theoris · 3 weeks ago
Senior Technical Writer
Indianapolis, IN
Contract
Hybrid
Senior Level
5+ years expTheoris is assisting their client in finding a Senior Technical Writer in a regulated pharmaceutical environment. This role involves reviewing and standardizing technical documentation to ensure compliance with internal quality standards and regulatory requirements while collaborating with various internal teams.
ConsultingInformation TechnologyStaffing Agency
Hiring Manager
Glynis B.
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
Qualification
Required
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
Benefits
Robust Health Insurance
401(k) plan
PTO accrual
Paid holidays
Excellent cash-based referral program
Company
Theoris
A nimble and collaborative strategic data management partner, solving complex enterprise data analytics and integration challenges, Indianapolis-based Theoris - expertly serves clients in life science, healthcare, manufacturing, financial services, and other demanding industries with strategic consulting, managed data solutions, app development and integration, cloud initiatives, and skilled IT and engineering talent acquisition – for over 40 years and counting.
201-500 employees
Funding
Current Stage
Growth StageTotal Funding
unknown2024-04-23Acquired
Leadership Team
George Huntley
Chief Operating Officer/Chief Financial Officer
Company data provided by crunchbase