Medical Writer: Risk Assessments & Documentation

LanceSoft Inc; Raritan (NJ); On-site; USD 80,000 - 100,000; Full time

Job summary

A leading healthcare consultancy in New Jersey is searching for a highly skilled individual to produce Product Risk Assessments for pharmaceutical products. Candidates should have at least five years of relevant experience, particularly in risk assessments of combination products and medical devices. Strong technical writing and project management skills are essential. Familiarity with the pharmaceutical industry, including knowledge of cGMPs, is mandatory. This role requires collaboration across various teams and proficiency in tools like Microsoft Office.

Qualifications

• Minimum of 5 years experience in pharmaceutical risk assessments.
• Proficiency in technical writing for manufacturing related activities is a must.
• Experience in Pharmaceutical manufacturing industry and regulatory requirements.

Responsibilities

• Write Product Risk Assessment documents for Pharmaceutical Products.
• Collaborate with medical, technical, manufacturing, and quality groups.
• Conduct risk analysis for pharmaceutical products.

Skills

Risk management methodologies

Technical writing

Project management

Documentation systems

Communication skills

Education

Bachelor's degree in Chemistry, Pharmacy or related field

MS/PhD/Pharm.D.

Tools

Microsoft Word

Microsoft Excel

Microsoft Visio

Microsoft Project

Job description

A leading healthcare consultancy in New Jersey is searching for a highly skilled individual to produce Product Risk Assessments for pharmaceutical products. Candidates should have at least five years of relevant experience, particularly in risk assessments of combination products and medical devices. Strong technical writing and project management skills are essential. Familiarity with the pharmaceutical industry, including knowledge of cGMPs, is mandatory. This role requires collaboration across various teams and proficiency in tools like Microsoft Office.