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Documentation Analyst - Job Opportunity at Enterprise Solution Inc.

Remote, US
Contract
Mid-level
Posted: February 25, 2025
Remote
USD 74,880 - 82,000 per year

Benefits

Remote work flexibility
Standard contractor arrangement

Key Responsibilities

Manage CMC regulatory submission document preparation and compliance
Coordinate document review processes and facilitate consensus meetings
Ensure data verification accuracy
Author CMC regulatory filing elements
Collaborate with cross-functional teams and subject matter experts

Requirements

Education

Bachelor's degree in relevant discipline OR Master's degree

Experience

4-7 years with Bachelor's OR 1-3 years with Master's

Required Skills

Regulatory CMC submission knowledge Team collaboration Time management Organizational skills Electronic systems proficiency Cell Therapy experience (preferred) CMC experience (preferred)
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Sauge AI Market Intelligence

Industry Trends

The pharmaceutical documentation and regulatory compliance sector is experiencing increased demand due to heightened regulatory scrutiny and complex submission requirements. Remote documentation analyst roles are becoming more prevalent as companies adapt to distributed workforce models. Cell therapy expertise is increasingly valuable as this therapeutic area continues rapid growth and development.

Salary Evaluation

The offered compensation range of $74,880-82,000 annually aligns with market rates for contract documentation analysts, though rates can vary +/-15% based on specific expertise in cell therapy.

Role Significance

Typically part of a 5-8 person regulatory affairs team, working with multiple cross-functional groups.
Mid-level position with significant responsibility for regulatory compliance and documentation quality.

Key Projects

CMC regulatory submissions for novel therapies Documentation system optimization Compliance framework implementation Cross-functional process improvement initiatives

Success Factors

Strong attention to detail and quality control expertise Ability to manage multiple stakeholders and deadlines effectively Deep understanding of regulatory requirements and CMC documentation Excellent project management and organizational capabilities

Market Demand

High demand, particularly driven by increasing regulatory requirements and the growth of specialized therapeutic areas like cell therapy.

Important Skills

Critical Skills

CMC regulatory knowledge - Essential for ensuring compliance and submission quality Documentation system expertise - Critical for managing complex submission processes Cross-functional communication - Key for coordinating with various stakeholders

Beneficial Skills

Cell therapy knowledge - Valuable for specialization and career advancement Project management - Helpful for handling multiple submission timelines Quality control systems - Important for maintaining documentation standards

Unique Aspects

Focus on cell therapy documentation indicates cutting-edge therapeutic area involvement
Remote work structure offers flexibility while maintaining high-quality regulatory standards
Strong emphasis on cross-functional collaboration despite remote setup

Career Growth

2-3 years in role typically required before advancement, with additional technical or management training

Potential Next Roles

Senior Documentation Analyst Regulatory Affairs Manager CMC Technical Writer Lead Compliance Manager

Company Overview

Enterprise Solution Inc.

Enterprise Solution Inc. appears to be a specialized pharmaceutical services provider focusing on regulatory compliance and documentation.

Mid-sized player in the pharmaceutical services sector, competing with larger CROs and specialized documentation firms.
US-based operations with remote work capabilities suggesting national reach.
Remote-first environment with emphasis on independent work capability and cross-functional collaboration.
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  • Salary estimates and market demand analysis
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  • Critical success factors and key skills
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