Technical Writer – Scientific (Pharmaceutical/Bioanalytical)

Position Summary

As a Technical Writer, you’ll be responsible for developing, reviewing, and maintaining clear, accurate, and compliant technical documentation to support our client’s pharmaceutical and bioanalytical operations. Success in this role requires strong scientific understanding, exceptional attention to detail, and a commitment to accuracy in a regulated environment.

Key Responsibilities

• Author, review, and maintain SOPs, work instructions, protocols, technical reports, validation documents, and other regulated materials.
• Translate complex scientific and technical information into clear, concise, and compliant documentation.
• Ensure that all documents comply with GLP, GxP, FDA, and applicable regulatory/internal standards.
• Collaborate closely with scientists, quality, regulatory, and operations teams to ensure technical accuracy and clarity.
• Manage the document lifecycle—including change control, versioning, and archival.
• Prepare and update documentation in support of inspections, audits, and client/regulatory requests.

Required Qualifications

• Bachelor’s degree in Life Sciences, Chemistry, Biology, or related field.
• Minimum of 3 years’ technical writing experience in pharmaceutical, biotech, CRO, or CDMO settings.
• Strong understanding of regulated environments and quality systems.
• Exceptional attention to detail and a commitment to data integrity and accuracy.
• Excellent written and verbal communication skills.

Preferred Qualifications

• Experience in bioanalytical laboratory environments (e.g., LC-MS/MS, immunoassays, pharmacokinetics).
• Experience supporting regulatory inspections and audits.
• Familiarity with document management systems and change control processes.

Key Competencies

• Excellent technical and scientific comprehension.
• Accuracy, consistency, and meticulous attention to detail.
• Strong organizational and time-management skills.