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Employment Type:
Full time
Job Category:
Writing / Editing
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Associate Clinical Writer
Applied Medical Distribution Corporation | Rancho Santa Margarita, California
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Job Description


Applied Medical is dedicated to providing innovative products, programs and solutions that meet clinical needs and improve patient outcomes. Applied is equally committed to improving the affordability and accessibility of high-quality healthcare. Applied Medical's team members enjoy a dynamic, team-focused environment that allows opportunity for growth in individual career paths through skills development, training and advanced business knowledge. If you would like to be a part of a company making a significant and sustainable impact on healthcare, then Applied Medical is the place for you.

Position Description

As an Associate Clinical Writer you will be responsible for working within the framework of a team and performing the following activities:

* Assist with the development and completion of scientific protocols and reports, including, but not limited to, Clinical Evaluations and Post Market Clinical Feedback as part of design validation for medical devices to support product registrations internationally
* Assist with performing gap analyses and revisions of Clinical Evaluations
* Conduct scientific literature reviews and compile reports, such as annual literature updates and periodic safety updates, to provide to global regulatory agencies
* Assist with performing analytics and generating data visualization concepts to address unique problems in clinical research
* Assist in maintaining standard operating procedures and work instructions for preparation and maintenance of compliant medical writing deliverables

Position Requirements

This position requires the following skills and attributes:

* Bachelor's degree, preferably in a scientific field, or equivalent experience
* Ability to understand and interpret results of clinical studies, with a strong understanding of statistics
* Expertise in conducting focused literature searches on PubMed, MedLine or other similar literature databases
* Programming knowledge with R, Minitab and other statistical programs
* Ability to perform Mathematical/Statistical Analysis
* Effective written and oral communication skills
* Ability to collaborate in a team environment
* Basic project management and organizational skills
* Ability to prioritize and manage multiple projects
* Strong familiarity with Microsoft Office


This following skills and attributes are preferred:

* 1-3 previous internship(s) in scientific/research related field or 1+ years of research with professor