Clinical Systems Specialist

Simtra BioPharma Solutions•Bloomington, IN

16h

About The Position

The Clinical Systems Specialist serves as an in individual reporting unit the Clinical Operations Specialist. Responsible for developing, maintaining, and optimizing documentation that supports clinical manufacturing systems, workflows, authoring non conformance investigations and operational processes. This role blends deep technical writing expertise with hands-on understanding of clinical production environments, ensuring that complex system information is translated into clear, accurate, and user friendly materials for diverse audiences. The ideal candidate brings strong parenteral manufacturing experience, a collaborative mindset, and the ability to work closely with clinical, technical, and regulatory stakeholders to produce high quality documentation that meets organizational, compliance, and industry standards.

Requirements

Bachelor’s degree or associate degree with 4 years of applicable industry experience within the parenteral manufacturing industry
Demonstrated experience producing technical documentation for complex systems or regulated environments
Strong understanding of clinical workflows, terminology, and system interactions
Excellent written communication skills with meticulous attention to detail
Ability to manage multiple projects, prioritize tasks, and meet deadlines in a fast paced environment
Strong communication skills and problem solving abilities
Ability to communicate effectively with both technical and non technical stakeholders
Self directed, organized, and comfortable leading documentation initiatives
Commitment to accuracy, clarity, and continuous improvement

Responsibilities

Create, edit, and maintain comprehensive documentation for clinical systems and processes, including user guides, SOPs, workflow diagrams, release notes, training materials, investigations, and technical specifications
Collaborate with product managers, engineers, Operations team members, and quality teams to gather information and ensure documentation accuracy and completeness
Translate complex technical and clinical concepts into clear, accessible content
Ensure all documentation complies with regulatory, security, and quality standards relevant to clinical and healthcare environments
Lead documentation planning for new system features, process enhancements, and integrations
Conduct content audits to identify gaps, improve consistency, and maintain version control
Support training initiatives by developing instructional content and assisting with knowledge transfer activities
Serve as a subject matter expert on documentation best practices and clinical system workflows