Technical Writer - Analytical / CMC

Net2Source (N2S); Remote; USD 70,000 - 90,000; Full time

Job summary

A leading workforce solutions provider seeks a Technical Writer to develop regulatory documents and analytical test methods for a dynamic QC team. The ideal candidate will have a BS/BA in life sciences or engineering, with at least two years' experience in a cGMP laboratory. Proficiency in technical writing and communication is essential for success. This role offers a 12-month contract in a collaborative environment focused on professional growth.

Qualifications

• Minimum qualification is a BS/BA in life sciences or engineering.
• At least 2 years of experience in a cGMP laboratory environment.
• Experience in the biopharmaceutical manufacturing industry preferred.

Responsibilities

• Author and review technical documents including Regulatory Filing sections.
• Participate in document standards and management improvements.
• Collaborate with QC, Technical Operations, and Regulatory teams.

Skills

Technical writing

Strong communication skills

Team collaboration

Proactive mindset

Education

BS/BA in life sciences or engineering

Master's degree or PhD

Tools

MS Office Suite

Document repository systems

Job description

Join a Global Leader in Workforce Solutions - Net2Source Inc.

Who We Are

Net2Source Inc. isn't just another staffing company— we’re a powerhouse of innovation, connecting top talent with the right opportunities. Recognized for 300% growth in the past three years, we operate in 34 countries with a global team of 5,500+. Our mission? To bridge the talent gap with precision—Right Talent. Right Time. Right Place. Right Price.

Title: Technical Writer - Analytical & Regulatory (CMC)

Duration: 12 Months Contract

Location: Remote

Position Summary

We are seeking a Technical Writer to author and review Analytical Test Methods to commercialize procedures for the QC testing area by working closely with method experts. The candidate may also author and review documents supporting regulatory submissions in collaboration with regulatory teams. The successful candidate must function well and collaborate in a fast‑paced, integrated, multidisciplinary team environment.

Primary Responsibilities

• Author and critically review technical documents including Regulatory Filing sections and Analytical Test Methods
• Author and review documentation compliant with current Good Manufacturing Practices (cGMP), including Second Person Review or Second Scientist Review
• Participate in group initiatives related to document standards, template development, internal processes, and document management improvements
• Collaborate closely with key stakeholders across QC, Technical Operations, and Regulatory teams
• Support preparation of documentation related to CMC CTD Module 2/3 and Biologics License Applications (BLA)

Qualifications

• Education
  • Minimum qualification - BS/BA in life sciences or engineering required
  • Master's degree or PhD preferred
• Required Experience and Skills
  • At least 2 years of experience working in a cGMP laboratory environment
  • Experience in the biopharmaceutical manufacturing industry, including biologics or vaccines commercialization, technical operations, or quality control
  • Strong oral and written communication skills
  • Ability to work independently and within cross‑functional teams
  • Proactive and service‑oriented mindset
  • Experience with MS Office Suite and document repository systems
• Preferred Experience and Skills
  • Experience with analytical method validation and transfer according to ICH and USP guidelines
  • Experience with laboratory data management systems
  • Experience authoring and reviewing analytical test methods, regulatory filings, CMC CTD Module 2/3, or Biologics License Applications (BLA)
• Personal Attributes
  • Detail‑oriented
  • Excellent technical writing skills
  • Collaborative team player
  • Strong communication and interpersonal skills

Why Work With Us?

We believe in more than just jobs— we build careers. At Net2Source, we champion leadership at all levels, celebrate diverse perspectives, and empower you to make an impact.

Our Commitment to Inclusion & Equity

Net2Source is an equal opportunity employer, dedicated to fostering a workplace where diverse talents and perspectives are valued. Employment decisions are made based on merit and business needs.

Awards & Recognition

• America's Most Honored Businesses (Top 10%)
• Fastest‑Growing Staffing Firm by Staffing Industry Analysts
• INC 5000 List for Eight Consecutive Years
• Top 100 by Dallas Business Journal
• Spirit of Alliance Award by Agile1

Ready to Level Up Your Career?

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