Clinical Medical/Technical Writer

Kelly Services® has been providing outstanding employment opportunities to the most talented individuals in the marketplace. We are proud to offer a long-term temporary opportunity to work as a Clinical Medical/Technical Writer at a prestigious Fortune 500® company working in Concord, CA.Important information: This position is recruited for by a remote Kelly office, not your local Kelly branch. To be considered for this position, you must use the “Submit Resume” button to submit your resumes. If you have questions about the position, you may contact the recruiter for this position ( Brooke.Schoen@kellyservices.com ) however your resume must be received via the “Submit Resume” button included within.Job Title: Clinical Medical/Technical WriterPay: $30 per hour depending on experienceSummary :Looking for a qualified Clinical Medical/Technical Writer to assist in the development, drafting, review, editing, and finalization of documents used in conducting clinical studies and reporting clinical study results for regulatory submissions and publications.ResponsibilitiesDrafts and edits documents used in conducting and reporting the results of clinical studies, including protocols, protocol amendments, informed consent forms, clinical study reports; and technical dossiers Conducts comprehensive literature evaluations, product complaint reviews, and other product specific information to compile literature based clinical evaluation reports. Manages study team participation in the preparation of such documents, including calling/running meetings, developing timelines, and managing the document review and comment adjudication processes Provides peer review and editing support for other regulatory documents, such as statistical analysis plans, CRFs, and other study materialsEducationBachelors or higher degree preferred; scientific focus desirable. Minimum requirement: University-level medical or technical writing course(s) or equivalent experience in science/technical writing. Evidence of medical writing career development, eg, American Medical Writers Association certificate, Editor in Life Sciences certificate, or relevant training through Drug Information Association.ExperienceFulfills one of the following: Up to 2 years of as a medical writer in the medical device industry At least 5 years of medical or scientific writing experience as a primary job responsibility Medical Writing Experience writing, reviewing, or editing protocols and clinical study reports and literature based clinical evaluations highly preferred. Intermediate to advanced applied knowledge of routine document content preparation, including the use of style guides, medical dictionaries, and guidance documents that prescribe content. Intermediate to advanced applied knowledge of AMA, CBE, and Chicago Style Manuals. Ability to interpret basic tabular and graphical clinical data presentations. Ability to create basic tables using AMA style (eg, Schedule of Events). Intermediate applied knowledge of basic clinical laboratory tests. Basic understanding of the concepts of coding dictionaries (MedDRA, WHO Drug). Basic understanding of biostatistical and clinical research concepts. Regulatory Basic knowledge of regulatory requirements and guidances associated with standalone regulatory documents (eg, protocols, investigator brochures, and clinical study reports).Fundamental Job Duties : Sit side-by-side and work with several members of our team to create in-depth processes maps and standard works for processes that are relatively simple to fairly complex Test documentation for accuracy and consistency Identify areas that may require additional process improvements or documented structure and develop thoughtful recommendations for execution Utilize Great Plains ERP system to include graphical instructions along with written detail to deliver the appropriate level of detail for both audit purposes and new user training Provide regular communication and synchronization with multiple points of contacts at remote locations to provide updates to progress and deliver completion timelinesWhat we’re looking for : Bachelor's degree or equivalent experience in English, Communication, or Journalism. 2-5 years experience working as a Technical Writer or in related job role. Ability to analyze and synthesize complex content. Strong technical aptitude–ability to quickly learn new concepts and tools. Excellent writing and prooing skills. Ability to write clearly and succinctly for multiple audiences using either formal or more casual tones. Excellent work ethic and strong intellectual curiosity. Ability to work quickly, efficiently, and multi-task. Desire and ability to innovate and improve upon current processes. Experience creating infographics to more clearly communicate workflow processes and abstract topics Track record of effective collaboration Experience working with Subject Matter Experts (SMEs) both in-person and remote. Experience in prioritizing and understanding the lifecycle of documentation from pre-release through on-going maintenance. Experience creating infographics such as diagrams, screenshots, workflows, graphs, etc.We invite you to bookmark our Web site and encourage you to review it regularly for new opportunities worldwide: www.kellyservices.com at http://www.kellyservices.com/ .Kelly Services® is a U.S.-based Fortune 500 company. With our global network of branch locations, we are uniquely positioned to provide our customers with international staffing support and our employees with diverse assignments around the world.Kelly Services is an Equal Opportunity EmployerWhy Kelly ® ?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/non-traditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. 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 and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Kelly will work with applicants to meet accommodation needs that are made known to Kelly in advance.