Regulatory Medical Writer - Pharma/Biotech Experience Required

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.