| name | job-description |
| description | Generate job descriptions for clinical trial technology roles at Talosix. Includes required regulatory knowledge, competitive positioning for the talent market, and DEI-inclusive language. |
Job Description Skill
Generate comprehensive, DEI-inclusive job descriptions for Talosix roles. Tailored for clinical trial technology positions that require a blend of technical skills and regulatory domain knowledge.
When to Use
- Creating a new job requisition
- Updating an existing job description
- Reviewing a draft JD for completeness and inclusive language
- Benchmarking role requirements against market standards
Job Description Structure
When asked to generate a job description, produce the following sections:
Template
# <Job Title>
**Department:** <department>
**Location:** <location / remote policy>
**Reports To:** <manager title>
**Employment Type:** Full-time
---
## About Talosix
Talosix builds electronic data capture (EDC) software for clinical trials, enabling
pharmaceutical companies, biotech firms, and CROs to collect, manage, and analyze
clinical trial data with regulatory compliance. Our platform supports the development
of life-saving therapies by ensuring data integrity, patient safety, and regulatory
compliance across global clinical studies.
<2-3 paragraphs describing:>
What the team does and how this role fits
The impact this person will have
What makes this role exciting or unique
<5-8 responsibilities total>
<5-7 required qualifications>
<3-5 preferred qualifications>
Familiarity with 21 CFR Part 11 requirements for electronic records
Understanding of GxP software development lifecycle (GAMP 5)
Experience with validated system development or regulated industries
Awareness of ICH E6 GCP guidelines (preferred)
Deep knowledge of 21 CFR Part 11, EU Annex 11
Experience writing and executing IQ/OQ/PQ protocols
Understanding of GAMP 5 risk-based approach
Computer System Validation (CSV) experience required
Regulatory inspection experience preferred
Understanding of clinical trial processes and terminology
Familiarity with CDISC standards (CDASH, SDTM)
Knowledge of EDC/eCRF design principles
Understanding of the drug development lifecycle
Competitive compensation (salary + equity)
Comprehensive health, dental, and vision coverage
Flexible PTO policy
Remote-friendly work environment
Professional development budget
Opportunity to contribute to life-saving therapeutic development
Talosix is an equal opportunity employer. We celebrate diversity and are committed
to creating an inclusive environment for all team members. We do not discriminate
based on race, color, religion, gender, gender identity or expression, sexual
orientation, national origin, genetics, disability, age, or veteran status.
We encourage candidates from all backgrounds to apply, even if you don't meet
every listed qualification. We value diverse perspectives and believe they strengthen
our team and our product.
