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Clinical Writer - On Call

Clinical Writer - On Call

SGSRichardson, TX, US
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Clinical Writer - On Call

We are SGS the worlds 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

The clinical writer I drafts study-specific protocols and clinical study reports (CSRs) using internal or client template and provided cost proposals, clinical data, International Council on Harmonisation (ICH) and Good Clinical Practice (GCP) guidelines, and other relevant information. The writer also coordinates internal and external protocol reviews and obtains client agreement.

  • Drafts 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 all departments as assigned
  • Completes training within required deadline
  • Adheres to internal standards, policies, and procedures
  • Performs other duties as assigned

Qualifications

EDUCATION AND EXPERIENCE

  • Bachelors degree (technical writing, English, or science preferred) Preferred
  • 0-2 years technical writing experience Preferred

    • KNOWLEDGE / SKILLS / ABILITIES

  • Strong technical writing and editing skills, organizational ability, research skills, attention to detail, and the ability to establish priorities with minimal supervision
  • Mathematical skills : Basic understanding of statistics or willingness and ability to learn

    • ADDITIONAL KSAS

  • Microsoft Word : Intermediate proficiency (including table creation)
  • Microsoft Excel : Basic proficiency

    • 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 companys rights to assign or reassign duties and responsibilities to this job at any time.

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