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.
- 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
- No travel required
- M-F; 8am-5pm
Kelly® Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interests—it's the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.About Kelly®
At Kelly, we're always thinking about what's next and advising job seekers on new ways of working to reach their full potential. In fact, we're a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.
Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law.]] About Kelly Services
Kelly Services, Inc. (NASDAQ: KELYA, KELYB) is a leader in providing workforce solutions.
Kelly offers a comprehensive array of outsourcing and consulting services as well as world-class staffing on a temporary, temporary-to-hire, and direct-hire basis.
Serving clients around the globe, Kelly provided employment to more than 540,000 employees in 2013. Revenue in 2013 was $5.4 billion.
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