Sgs Technologie LLC
Clinical Writer I
Richardson, TX, United States
Sponsorship not specifiedDetected 1 day ago
GCPStatisticsExcelClinical TrialsResearchWritingMicrosoft OfficeGxP
About the role
- 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.
- 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.
Requirements
- Intermediate proficiency (including table creation)
- Intermediate proficiency
- 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.
Nice to have
- 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
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