Clinical Writer - On Call
Clinical Writer - On Call
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Not Disclosed
Salary Not Disclosed
1 Vacancy
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.
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 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.
Remote Work :
No
Employment Type :
Part-time
Employment Type
Part-time
