Job Description

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.

## About This Role

<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

## What You'll Do

- <Responsibility 1: Start with action verb, be specific>
- <Responsibility 2>
- <Responsibility 3>
- <5-8 responsibilities total>

## What You Bring

### Required
- <Requirement 1: Skill or experience, with years if relevant>
- <Requirement 2>
- <Keep to genuine requirements, not wish-list items>
- <5-7 required qualifications>

### Preferred
- <Nice-to-have 1>
- <Nice-to-have 2>
- <3-5 preferred qualifications>

## Regulatory & Domain Knowledge

<Tailor this section to the role. Examples below.>

### For Engineering Roles:
- 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)

### For QA/Validation Roles:
- 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

### For Clinical/Product Roles:
- 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

## What We Offer

- 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
- <Additional benefits specific to the role or location>

## Equal Opportunity Statement

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.

DEI-Inclusive Language Guidelines

Words and Phrases to Avoid

Inclusive Writing Practices

1. Limit required qualifications: Research shows that underrepresented candidates are less likely to apply if they don't meet all listed requirements. Keep required qualifications to genuine must-haves.

2. Use "you" language: "What You'll Do" instead of "The candidate will." Direct address is more welcoming.

3. Show flexibility: Mention remote options, flexible hours, accommodations willingness.

4. Highlight growth: Emphasize learning opportunities and career development.

5. Avoid unnecessary jargon: Clinical trial acronyms are fine (domain-specific), but avoid unnecessary corporate buzzwords.

6. State compensation range: Transparency in compensation supports equity. Include salary range where legally required or as best practice.

7. Inclusive benefits language: Use "partner" not just "spouse." Mention parental leave (not just maternity). Include mental health support.

Role-Specific Regulatory Knowledge Requirements

Engineering (Software Development)

• 21 CFR Part 11 awareness
• GAMP 5 software lifecycle familiarity
• Understanding of validated system change control
• Experience with audit trail implementation
• Knowledge of data integrity (ALCOA+ principles)

Quality Assurance / Validation

• 21 CFR Part 11 and EU Annex 11 expertise
• Computer System Validation (CSV) lifecycle
• IQ/OQ/PQ protocol development and execution
• Traceability matrix management
• Deviation and CAPA management
• Regulatory inspection readiness

Product Management

• Clinical trial process knowledge
• EDC market landscape awareness
• Regulatory requirement translation to product features
• CDISC standards familiarity
• Understanding of sponsor, CRO, and site user needs

Data Science / Biostatistics

• CDISC data standards (CDASH, SDTM, ADaM)
• Clinical data management workflows
• Medical coding (MedDRA, WHODrug)
• Statistical analysis plan understanding
• Data review and cleaning processes

Customer Success / Implementation

• Clinical trial operational knowledge
• Study build and configuration experience
• Training delivery for clinical site staff
• Issue triage and escalation
• Sponsor and CRO relationship management

Competitive Positioning

When writing job descriptions, consider the talent market:

• Clinical trial tech is niche: Emphasize that candidates can have regulated industry experience (medical devices, pharma manufacturing, fintech) if they lack EDC-specific background
• Mission-driven: Emphasize the impact on patient lives and drug development
• Growth stage: Highlight the opportunity to shape products and processes
• Technical challenge: Clinical data systems have interesting technical problems (audit trails, validation, complex forms, global scale)
• Career growth: Small-to-mid companies offer faster career progression

Output Format

Generate job descriptions in clean markdown, ready for posting to job boards. Ensure all sections are complete. Flag any areas where the requester should provide additional specifics (e.g., compensation range, specific tech stack, team size).