INCOG BioPharma
We are seeking an Enterprise Systems Technical Writer who is agile, collaborative, and passionate about technology and systems development. This role blends technical writing expertise with core business systems analysis skills. The Enterprise Systems Technical Writer will work closely with IT, Quality, Validation, and project teams to quickly learn new processes and systems, then translate that knowledge into clear, accurate documentation—including SOPs, validation documents, and training materials—to support the deployment and adoption of new enterprise systems. You'll be instrumental in documenting new enterprise systems, ensuring GMP compliance, and enabling our teams to adopt technology that drives operational excellence.
Essential Job Functions
Rapidly learn new enterprise systems and business processes through collaboration with subject matter experts and hands-on exploration.
Develop, update, and maintain high-quality documentation such as Standard Operating Procedures (SOPs), validation protocols, user guides, and training materials for IT and business systems.
Partner with program managers, subject matter experts, quality assurance, and validation to capture requirements, workflows, and system capabilities.
Translate complex technical and business concepts into clear, user-friendly documentation for diverse audiences across the organization.
Support system deployment and adoption by creating materials that facilitate training and onboarding for personnel.
Ensure documentation aligns with regulatory requirements, industry standards (e.g., GxP, Data Integrity, Good Documentation Practices), and internal quality guidelines.
Participate in system validation activities, assisting with the creation and review of validation documentation.
Collaborate with stakeholders to identify documentation needs and continuously improve content based on feedback and evolving business processes.
Maintain version control and accessibility of documentation assets to ensure reliability and security.
Special Job Requirements
3+ years of experience in technical writing, preferably in IT or regulated environments.
2+ years of experience in business systems analysis or related roles.
Demonstrated ability to quickly learn new systems and processes.
Experience developing SOPs, validation documents, and training materials.
Experience with CSV documentation in pharmaceutical, biotech, or medical device industries.
Familiarity with software development life cycle, system validation, and compliance standards.
Excellent written and verbal communication skills.
Proficiency with documentation tools such as Microsoft Office Suite, Visio, or similar workflow mapping tools.
Experience creating visual documentation (process flows, system diagrams, user interface mockups)
Bachelor’s degree in Computer Science, Life Sciences, Engineering, Technical Communication, or equivalent experience.
Additional Preferences
Experience with enterprise systems is a plus (ERP, LIMS, QMS).
Advanced degree or certification in Informatics, Technical Writing, or Business Analysis is desirable.
Additional info about INCOG BioPharma Services At INCOG BioPharma we have built a world-class CDMO for parenteral injectable drugs. Our culture and priorities are different by design: focused on building long-term value for our customers, we are committed to a service‑culture mindset, technical excellence, and a collaborative and team‑centered approach to doing business.
If you crave the challenge of creating systems from scratch and believe you have insights for a better way of doing business, which benefits customers by ensuring quality outcomes and accelerating their route to market, we want to hear from you. Unless otherwise specified, all positions are based out of our Fishers, IN offices. Please note, we are a smoke‑free campus.
INCOG BioPharma is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. All employment decisions at INCOG BioPharma are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, sex (including pregnancy), age, physical disability, sexual orientation, family or parental status, or any other status protected by the laws or regulations in the locations where we operate. We will not tolerate discrimination or harassment based on any of these characteristics.
By submitting your resume and details, you are declaring that the information is correct and accurate.
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Essential Job Functions
Rapidly learn new enterprise systems and business processes through collaboration with subject matter experts and hands-on exploration.
Develop, update, and maintain high-quality documentation such as Standard Operating Procedures (SOPs), validation protocols, user guides, and training materials for IT and business systems.
Partner with program managers, subject matter experts, quality assurance, and validation to capture requirements, workflows, and system capabilities.
Translate complex technical and business concepts into clear, user-friendly documentation for diverse audiences across the organization.
Support system deployment and adoption by creating materials that facilitate training and onboarding for personnel.
Ensure documentation aligns with regulatory requirements, industry standards (e.g., GxP, Data Integrity, Good Documentation Practices), and internal quality guidelines.
Participate in system validation activities, assisting with the creation and review of validation documentation.
Collaborate with stakeholders to identify documentation needs and continuously improve content based on feedback and evolving business processes.
Maintain version control and accessibility of documentation assets to ensure reliability and security.
Special Job Requirements
3+ years of experience in technical writing, preferably in IT or regulated environments.
2+ years of experience in business systems analysis or related roles.
Demonstrated ability to quickly learn new systems and processes.
Experience developing SOPs, validation documents, and training materials.
Experience with CSV documentation in pharmaceutical, biotech, or medical device industries.
Familiarity with software development life cycle, system validation, and compliance standards.
Excellent written and verbal communication skills.
Proficiency with documentation tools such as Microsoft Office Suite, Visio, or similar workflow mapping tools.
Experience creating visual documentation (process flows, system diagrams, user interface mockups)
Bachelor’s degree in Computer Science, Life Sciences, Engineering, Technical Communication, or equivalent experience.
Additional Preferences
Experience with enterprise systems is a plus (ERP, LIMS, QMS).
Advanced degree or certification in Informatics, Technical Writing, or Business Analysis is desirable.
Additional info about INCOG BioPharma Services At INCOG BioPharma we have built a world-class CDMO for parenteral injectable drugs. Our culture and priorities are different by design: focused on building long-term value for our customers, we are committed to a service‑culture mindset, technical excellence, and a collaborative and team‑centered approach to doing business.
If you crave the challenge of creating systems from scratch and believe you have insights for a better way of doing business, which benefits customers by ensuring quality outcomes and accelerating their route to market, we want to hear from you. Unless otherwise specified, all positions are based out of our Fishers, IN offices. Please note, we are a smoke‑free campus.
INCOG BioPharma is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. All employment decisions at INCOG BioPharma are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, sex (including pregnancy), age, physical disability, sexual orientation, family or parental status, or any other status protected by the laws or regulations in the locations where we operate. We will not tolerate discrimination or harassment based on any of these characteristics.
By submitting your resume and details, you are declaring that the information is correct and accurate.
#J-18808-Ljbffr