Job Summary

A pharmaceutical company has an open position for a Telecommute Senior Pharmaceutical Regulatory Writer in Bedminster.

Individual must be able to fulfill the following responsibilities:

• Plan, write, edit, and review clinically focused regulatory documents such documents
• Conduct document kick-off meetings, participate in timeline planning, and facilitate cross-functional document development
• Develop processes and SOPs for Regulatory Writing

Must meet the following requirements for consideration:

• Office based minimum of 1 day per week and work remotely up to 4 days per week
• Bachelor’s degree with regulatory or medical writing experience in the pharmaceutical/biotechnology/medical device industry
• Minimum of 7 years of drug/biologics development experience
• Minimum of 5 years’ experience in the development of regulatory documents for Health Authority submission
• Experience in assembling scientifically complex data or information to support Key Messages
• All other requirements necessary for this position