Clinical Writer I
SGS · Richardson, TX · 1 mo ago
On-siteResearchFull-time
About the role
We are SGS – the world's leading testing, inspection and certification company. Recognized as the global benchmark for sustainability, quality and integrity, our 99,600 employees operate a network of 2,600 offices and laboratories, working together to enable a better, safer and more interconnected world.
Responsibilities
- Drafts protocols and reports for clinical studies on cosmetics or other claims using internal or client templates, study outlines, clinical data, International Council on Harmonisation (ICH) and Good Clinical Practice (GCP) guidelines, and other relevant information.
- Coordinates internal and external protocol reviews and obtains client agreement by project deadline.
- Writes and reviews ICH/GCP-adherent clinical study protocols.
- Drafts clinical study reports based on internal or client templates according to clinical data, protocol, amendments, and deviations; revises reports based on reviews by quality assurance, statistics department, investigators, client, and others.
- Assists in maintaining internal databases of protocol and report templates, bioinstrumentation specifications, clinical grading parameters, and client preferences.
- Assists in drafting and editing Standard Operating Procedures (SOPs) and Work Instructions (WI) for the department as assigned.
- Completes training within required deadlines.
- Adheres to internal standards, policies, and procedures.
Requirements
- Bachelor’s degree (technical writing, English, or science preferred).
- 0-4 years of technical writing experience.
- Strong technical writing and editing skills, including internal document consistency.
- Organizational ability, research skills, attention to detail, and the ability to establish priorities with minimal supervision.
- Microsoft Word: Intermediate proficiency (including table creation).
- Microsoft Excel: Intermediate proficiency.