Clinical Writer I

SGS; Richardson (TX); On-site; USD 65,000 - 90,000; Full time

Job summary

SGS in Richardson, TX is seeking a technical writer to draft protocols and reports for clinical studies on cosmetics or other claims, ensuring alignment with ICH and GCP guidelines.

You will coordinate internal and external protocol reviews, maintain templates and SOPs, and draft reports revised by QA, statistics, investigators and clients. Strong editing, organizational and research skills are essential.

Qualifications

• Bachelor’s degree in technical writing, English, or science.
• 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).

Responsibilities

• Drafts protocols and reports for clinical studies on cosmetics or other claims.
• Uses internal or client templates, study outlines, clinical data, ICH and GCP guidelines.
• Coordinates protocol reviews and obtains client agreement.
• Writes and reviews ICH/GCP-adherent protocols and coordinates reviews.
• Drafts clinical study reports and revises them after QA and client feedback.
• Assists in maintaining internal databases of templates and SOPs.

Skills

Technical writing

Editing

Attention to detail

Research skills

Education

Bachelor's degree in technical writing, English, or science

Tools

Microsoft Word

Job description

We are SGS – the world's leading testing, inspection and certification company. We are 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.

Job Description

• 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

Qualifications

• 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)

Additional Information

SGS is an Equal Opportunity Employer, and as such we recruit, hire, train, and promote persons in all job classifications without regard to race, color, religion, sex, national origin, disability, age, marital status, sexual orientation, gender identity or expression, genetics, status as a protected veteran, or any other characteristics protected by law.

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily with or without reasonable accommodations. The requirements listed above are representative of the knowledge, skills, and/or abilities required.

This job description should not be construed as an exhaustive statement of duties, responsibilities or requirements, but a general description of the job. Nothing contained herein restricts the company’s rights to assign or reassign duties and responsibilities to this job at any time.

If you are applying for a position within the United States and you have difficulty completing the on-line employment application because of a disability, please call 201-508-3149 for assistance and leave a message. You will receive a call back. Please note, this phone number is not for general employment information, but is only for individuals who are experiencing difficulty applying for a position due to a disability.

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