Company: SGS North America
Posted on: January 11, 2022
Company Description - SGS is the global leader and innovator in
inspection, verification, testing and certification services.
Founded in 1878, SGS is recognized as the global benchmark in
quality and integrity. With over 97,000 employees in 130 countries
and operating a network of more than 2,400 offices and
laboratories, we provide services to almost every industry by
assuring quality and safety of products and services.
Trusted all over the world, SGS is a market leader because we put
100% passion, pride and innovation into everything we do. We
encourage new ideas. We welcome people who challenge the way we do
things. And we will be 100% committed to helping you reach your
Job Description - As the Clinical Writer, you will be -responsible
for drafting study-specific protocols and clinical study reports
(CSRs) using internal or client template and provided cost
proposals, clinical data, International Council on Harmonization
(ICH) and Good Clinical Practice (GCP) guidelines, and other
relevant information. This position also coordinates internal and
external protocol reviews and obtains client agreement.
Reasonable accommodations may be made to enable individuals with
disabilities to perform the essential functions.
Drafts and reviews ICH/GCP-adherent clinical study protocols,
coordinate internal and external reviews, and obtains client
agreement by the 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
Completes training within the required deadline.
Adheres to internal standards, policies, and procedures.
Performs other duties as assigned.
Qualifications - Required:
Bachelor's degree (technical writing, English, or science
0-2 years of technical writing experience
Strong technical writing and editing skills, organizational
ability, research skills, attention to detail, and the ability to
establish priorities with minimal supervision
Microsoft Word: Intermediate proficiency (including table
Microsoft Excel: Basic proficiency
Mathematical skills: Basic understanding of statistics or
willingness and ability to learn
Work in office and work from home as required by supervisor
No travel required
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
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
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 callback. - 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.
Keywords: SGS North America, Richardson , Clinical Writer, Advertising , Richardson, Texas
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