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25 days old

REMOTE Technical Writer IV-CERs

Kelly Services
Portland, OR 97240
**Kelly Services** is currently seeking a **REMOTE Technical Writer** to work a contract assignment 12 **month duration** for one of our top clients. Kelly is a full service workforce solutions provider to 98% of the Fortune 100 companies. We provide employment to more than 700,000 people annually and we deal with some of the largest and best companies both nationally and locally.


**Primary Responsibilities includes:**


The purpose of this role is to use medical writing and literature review experience to generate Clinical Evaluation Reports CERs and other associated documents in accordance with the appropriate regulatory standards EU MDR to ensure continued CE registration of company products.


Responsibilities:


+ Leads completion of clinical evaluation reports CERs , Benefit Risk Analysis BRAs , Clinical Evaluation Plans CEPs , and Summary of Safety and Clinical Performance SSCPs for CE registration including guidance to less experienced team members

+ Works with internal teams to gain cross-functional inputs and approvals into evidence evaluation documentation activities

+ Generates and maintain reference databases


Education: Bachelors in a relevant discipline required. Master s degree or PhD preferred.


Licenses/ Certifications:Experience:


+ Minimum 2 years experience authoring Clinical Evaluation Reports

+ Proven experience of performing literature reviews, analysing data sets and communicating the outputs.

+ Experience working within a medical device company in a Research Development, Scientific and Medical Affairs, Clinical or Regulatory role.

+ Experience in writing scientific documents for regulatory submissions

+ Experience in presenting scientific/clinical evidence in a written and oral manner to cross-discipline teams.


Competences:


+ Excellent scientific writing skills.

+ Strong data extraction and analysis skills.

+ Good communicator and able to work collaboratively as part of a team.

+ Self-motivated and able to work independently.

+ Excellent time management skills and ability to work under pressure to deadlines.

+ Must exhibit high quality, ethical and compliant work habits.

+ Experience in using Microsoft Word, Excel, PowerPoint.

+ Experience with EndNote


**APPLY NOW!**


**For immediate consideration, please send your resume in a WORD document to gaut985@kellyservices.com**


**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. 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)
Posted: 2021-02-05 Expires: 2021-03-08

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REMOTE Technical Writer IV-CERs

Kelly Services
Portland, OR 97240

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