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24 days old

Senior Medical Writer For Leader In Spine Technology Innovation

Kelly Services
San Diego, CA 92108
**Company/Position Summary**


+ Medical device company developing minimally disruptive surgical products and procedurally integrated solutions for the spine.

+ Summarizes data from pre-clinical and clinical studies.

+ Prepares clinical reports, summary documents, package inserts and other documents to be submitted to the Food and Drug Administration and the World Health Organization for publication and/or presentation.

+ Assists in the development of formats and guidelines for clinical documentation.

+ Prepares scientific manuscripts, abstracts and posters as needed.

+ Supports clinical research associates and medical doctors in clinical protocol development. Primary Responsibilities

+ Provides a full range of written communication in accordance with the needs of the customer and organization

+ Prepares the draft case report forms CRFs , statistical analysis plans SAPs , and in blinded data listing reviews prior to database lock and provide feedback to the team

+ Participates in document review meetings to determine accurate and appropriate protocol design and interpretation of study results Interprets non-clinical and clinical data in preparation for various technical reports

+ Reviews all promotional materials and clinical data presentations to ensure medical accuracy and regulatory compliance

+ Supports research-related questions and independently provides internal and external training as necessary

+ Performs other duties as assigned


**Required Skills / Capabilities**


+ Solid understanding of medical terminology

+ Proficient in post-market project and data management, data analysis, and medical writing techniques Intermediate level proficiency with word processing Word, spreadsheets Excel , presentation programs Power Point , charting, flow charting, and graphs

+ Solid written and verbal communication skills, analytical ability and problem-solving skills Advanced organizational and time-management skills with the ability to prioritize multiple projects and successfully meet deadlines


**Education and Experience**


+ Minimum of 5 years of related experience with a Bachelors degree; or 3 years and a Masters degree; or a PhD without experience; or equivalent work experience

+ Experience in a clinical or industry setting with study experience focused on Spine, Orthopedics, or Medical Devices preferred

+ Nature and Scope for reference only Applies in-depth specialty knowledge within subject area to complete assignments of diverse scope; contributes to the development of new plans, models, standards and techniques

+ Solves problems in complicated situations through the application and integration of analytical skills, creativity and judgment

+ Leads projects of limited scope; provides training and constructive input to team members

+ Adapts communication to accommodate audience diversity and may communicate internally at higher levels Impacts business performance and operational efficiency through the delivery of results


**Why 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 interestsits 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, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were 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. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)

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Posted: 2021-03-29 Expires: 2021-05-03

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Senior Medical Writer For Leader In Spine Technology Innovation

Kelly Services
San Diego, CA 92108

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