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Sr. Medical Writer

Company: Joule Staffing
Location: Brookline
Posted on: June 17, 2022

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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