Contract Associate Technical Writer

Associate Technical Writer at Kymanox

Kymanox, a life sciences professional services company headquartered in Research Triangle Park, NC, has successfully delivered over 4000 projects across 20+ countries.

Kymanox is seeking an Associate Technical Writer with a strong background in FDA‑regulated environments (pharmaceutical, biotechnology, medical device, or combination products). The successful candidate will author and revise high‑quality, compliant documentation including Standard Operating Procedures (SOPs), work instructions, test methods, protocols, and reports across multiple functional areas in a cGMP environment.

• Author, revise, and format controlled documents (SOPs, work instructions, protocols, test methods, specifications, reports, etc.) in accordance with client templates and FDA/ICH regulatory expectations
• Collaborate daily with client subject‑matter experts (SMEs) across Engineering, Manufacturing, Quality Control, Quality Assurance, Facilities, EHS, Warehouse/Supply Chain, and IT to gather technical content
• Support Design History File (DHF) remediation and gap assessments as needed
• Ensure traceability, consistency, and compliance with 21 CFR 210/211, 820, Part 4 (combination products), EU Annex 11, and data integrity requirements
• Manage document review/approval cycles using client electronic document management systems
• Participate in client meetings, present drafts, and incorporate feedback efficiently while maintaining positive, professional relationships

Bachelor’s degree in engineering (Biomedical, Mechanical, Chemical preferred), Life Sciences, Technical Communication, or related STEM discipline.

• Minimum 0‑2 years of experience of technical writing experience in FDA‑regulated pharmaceutical, biotechnology, medical device, or combination product environments
• Demonstrated experience authoring FDA‑compliant SOPs, protocols, test methods, work instructions, and reports in a cGMP or QSR setting
• Proven ability to interview SMEs, translate complex technical concepts into clear, concise, and compliant documentation
• Excellent client‑facing interpersonal skills — professional, courteous, accommodating, high emotional intelligence (EQ), active listening, and a pleasant communication style

• Understanding of DHF remediation, CAPA‑driven documentation updates, or site‑readiness projects
• Familiarity with equipment qualification (FAT/SAT/IQOQ/PQ), utility systems, QC laboratory methods, cleaning validation, or process validation documentation
• Experience in or familiarity with regulated environments with high‑visibility audits (FDA, EMA, notified bodies)
• Proficiency with Veeva Vault, Master Control, or similar EDMS platforms
• Resourceful
• Detail oriented
• Ability to work effectively with remote team members
• Highly organized
• Self‑directing, self‑pacing
• Excellent written and oral English communication skills
• Ability to solicit and utilize subject matter expert input
• Pleasant and positive communication style
  
  Strong customer‑service aptitude
• High energy level
• Excellent problem‑solving skills
• Seasoned soft skills (i.e., high EQ)
• Team player

Hourly rate is commensurate with experience, qualifications, and other intangibles evident during the interview process – as well as market conditions.

Join Kymanox – a life sciences professional services company dedicated to life sciences who has successfully delivered over 4000 projects across 20+ countries. It provides an outstanding opportunity for learning and career advancement, encouraging team members to work on a variety of projects to gain increased learnings in Kymanox’s service offerings and the life science industry as a whole. Kymanox provides professional services related to engineering, compliance, and project management, servicing clients ranging from Fortune 100 companies to virtual start‑up companies.

Entry level

Contract

Marketing, Public Relations, and Writing/Editing

Professional Services

Kymanox is an equal‑opportunity employer and works diligently to protect the rights of job seekers by following all local, state, and federal laws as well as best Human Resource (HR) practices in the Life Science industry.