Direct message the job poster from Proclinical Staffing
Phu Huynh
Senior Director at Proclinical Staffing
Regulatory Medical Writer - Permanent - Remote
Proclinical is seeking a Regulatory Medical Writer for a regulatory consulting firm with their location in Virginia.
Primary Responsibilities:
In this role, you will write and review regulatory submissions, such as Pre-INDs, INDs, CTDs, ODDs (FDA and EMA) and white papers.
The position will be remote-based within the United States.
Skills & Requirements:
PhD in a life science or related field of study
Minimum of 3 - 5 years relevant experience in Regulatory Affairs within the pharmaceutical or biotechnology industry
Recent experience working at a CRO or pharmaceutical/regulatory consulting firm is preferrable
The Regulatory Medical Writer will:
Demonstrate expertise in FDA regulated product development
Demonstrate expertise in ex-US drug and device development a plus
Experience in writing and reviewing regulatory submissions, such as Pre-INDs, INDs, CTDs, ODDs (FDA and EMA), and white papers. Experience with CMC writing (FDA and EMA) is preferred
Understands the client’s problem(s), conceptualizes how to solve it and achieve task objectives
Contributes scientific and innovative thinking
Contributes significantly to a high-quality work product acceptable to the senior consultant, on time and within budget
Effectively manages deadlines and multi-tasks
Engages actively in publishing of articles
Performs literature reviews
If you are having difficulty in applying or if you have any questions, please contact Phu Huynh at (+1) 646-779-7961 or p.huynh@proclinical.com.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Research and Science
Industries
Biotechnology Research and Pharmaceutical Manufacturing
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