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Enterprise Systems Technical Writer
INCOG Biopharma Services in Indianapolis, IN is hiring 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.
There is a growing need globally for more CDMOs (contract development and manufacturing organization) in the pharmaceutical industry to provide comprehensive services from drug development through drug manufacturing.
At INCOG, they are more than just a CDMO. A better way to create more meaningful experiences. A better way to create a culture that everyone can thrive and succeed in. At their core, that is who they are—a dedicated team that believes they can always be better.
Join the team at INCOG, a world-class CDMO for parenteral injectable drugs, shaping a new future for patients, for yourself, and for INCOG’s clients.
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.
Candidate 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.
Why INCOG?
- Paid time off, based on tenure
- 11 paid holidays
- 401(k) plan with company match up, vested immediately
- Choice of health & wellness plans
- FSA and HSA options
- Onsite wellness facility
- Employee engagement activities; food trucks, monthly luncheons, fundraising events, team building competitions, offsite celebrations
Don’t meet all the requirements? Don’t sweat! We’re always looking for an excuse to discuss your next opportunity. You might just surprise yourself…
Lead Candidate wholeheartedly supports Equality and Diversity in employment and opposes all forms of unlawful or unfair discrimination on the grounds of age, disability, sex, gender reassignment, sexual orientation, pregnancy and maternity, race, religion or belief and marriage and civil partnerships.
