Sr. Medical Writer
Company: Joule Staffing
Location: Brookline
Posted on: June 17, 2022
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Job Description:
Title: Sr. Medical Writer Location: 100% remote with EST hours
Duration: Direct Hire Perm Start: ASAP Requirements: Degree: - BS
or MS required, Higher graduate degree is preferred - Minimum of
7-10 years of experience in the medical device/pharmaceutical
industry - Minimum of 5 yrs. exp. in medical/scientific writing -
Manage numerous external vendors and contingent workers
(supervisory role) - Clear, concise scientific style of writing;
attention to detail to provide high-quality results - Technical
writing experience - Exp. writing Clinical Evaluation Reports -
Basic knowledge of biostatistics and medical background/application
of client's products - Affinity to scientific literature and data
analyses using state-of-art information technology
Duties/Responsibilities: -Creation and maintenance of regulatory
documents related to clinical data of products (CER, SSCP, PMCF) in
liaison with other departments - Plan and execute structured
literature searches, identify and analyze relevant clinical data -
Write Clinical Evaluation plans and reports in compliance with
applicable regulatory requirements (EU MDR, MEDDEV 2.7/1, MDCG) -
Write PMCF plans, protocols and reports; work with Project
Management to manage cross-functional stakeholders and review and
integrate their input into PMCF plans and reports - Write study
protocols, safety plans and reports in liaison with Medical and
Regulatory Affairs - Support Medical Affairs and Regulatory Affairs
in development and execution of regulatory strategies - Manage
vendors; Plan and coordinate vendor activities - Manage temporary
worker staff (1-2 people over time) Joule, a System One division is
a leader in specialized workforce solutions and integrated
services. With more than 6,000 employees and roughly 50 offices
throughout the U.S. we provide scientific, clinical, engineering,
energy, IT, legal and administrative staffing services. For more
than 40 years, we have delivered workforce solutions and integrated
services to clients nationally.
Keywords: Joule Staffing, Brookline , Sr. Medical Writer, Healthcare , Brookline, Massachusetts
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