Description:
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.
The 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
Required qualifications:
- 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