Clinical Writer I

SGS • Richardson, TX

24d • Onsite

About The Position

Drafts protocols and reports for clinical studies on cosmetics or other claims. Uses internal or client template, study outline, 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. Writes and reviews ICH/GCP-adherent clinical study protocols, coordinates internal and external reviews, and obtains client agreement by project deadline. Drafts clinical study reports based on internal or client template according to clinical data, protocol and 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 department as assigned. Completes training within required deadline. Adheres to internal standards, policies, and procedures.

Requirements

• Bachelor’s degree (technical writing, English, or science preferred).
• 0-4 years 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

Responsibilities

• Drafts protocols and reports for clinical studies on cosmetics or other claims.
• Uses internal or client template, study outline, 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.
• Writes and reviews ICH/GCP-adherent clinical study protocols, coordinates internal and external reviews, and obtains client agreement by project deadline.
• Drafts clinical study reports based on internal or client template according to clinical data, protocol and 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 department as assigned.
• Completes training within required deadline.
• Adheres to internal standards, policies, and procedures.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level