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 assigned.
• 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 preferred)
• 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 creation)
• 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 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 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.