Medical Writer Kelly® Science & Clinical is seeking a Medical Writer for our client in Rochester, New York. If you're passionate about bringing the latest scientific discoveries to life and are ready to take the next step in your career, trust The Experts at Hiring Experts.
This client is a company that's leading the way med device industry.
Schedule : Monday through Friday 8am to 5pm
Length of assignment: Approximately six months
Pay: Hourly rates Depending on experience
Remote option Responsibilities Primary responsibility will be updating standard operating procedures to meet current standards/regulations and processes. Able to develop Clinical Study Protocol and Clinical Study Report Templates for Medical Devices and Pharma (independently) following ISO 14155:2020 (for Device) and ICH E6 (R3) for Pharma
High proficiency level with the following: 21 CFR 50, 54, 56, 58, 312, 812
ISO 14155:2020
MDR 2017:745
ICH E6 (R2)
Good Clinical Practice
Standard Operating Procedures
Experience writing: SOPs and reference documents
Clinical Study Report
Clinical Study Protocol
Investigator Brochure
Standard Operating Procedure
Requirements: Bachelor is Science and 3 plus years of Medical Writing experience
Familiar with Documentum a plus
Good Clinical Practice
Standard Operating Procedures
Clinical Study Report writing experience
Clinical Study Protocol writing experience
Investigator Brochure writing experience
Standard Operating Procedure Writing Experience
Medical Device experience preferred
Ophthalmology experience preferred
What happens next Once you apply, you'll proceed to the next steps if your skills and experience look like a good fit. But don't worry—even if this position doesn't work out, you're still in our network. That means all of our recruiters will have access to your profile, expanding your opportunities even more.
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As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here ( for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.
