TKL Research is a full-service, international Clinical Research Organization (CRO) serving the pharmaceutical, biotechnology, medical device and consumer healthcare industries. We provide comprehensive clinical trial management services for Phase 1-4 clinical research studies, including an inpatient Phase 1 facility and outpatient specialized research clinics.
We are seeking a highly motivated Medical Writer for our growing organization!
The Medical Writer assists the Medical Writing department in the performance of project-related medical writing activities within a team-oriented environment targeted to deliver quality products to internal and external clients.
Responsibilities include but are not limited to:
- Preparation and compilation of clinical documents including study protocols, study reports, and summary documents according to ICH guidelines, TKL SOPs, and sponsor requirements
- Preparation of scientific documents including journal articles, literature reviews, poster presentations, and product monographs
- Contribution to the development and maintenance of standard document templates for format and content of clinical documents including study protocols and study reports
- Assistance in interdepartmental quality control review of documents prior to submission for quality assurance review by TKL auditors and sponsor review
Min Bachelor’s degree or equivalent academic credential in biology or a health science, Masters Degree or higher preferred. 6 months to 1 year writing experience involving the compilation of scientific information and/or data. General office skills, strong computer proficiency with MS Office, strong organization skills, detail orientation and excellent communication skills are required.
We offer a competitive compensation package for full time employees, commensurate with your background and experience, including full benefits, 401(k) with match and a profit sharing plan.
This is a full-time position based in our Rochelle Park, NJ headquarters.