The Medical Writer will be responsible for coordinating medical writing activities for Medical Writing projects. This is a fully remote opportunity.

• Independently write, edit, and compile clinical/regulatory documents specifically protocol development for all phase clinical trials, clinical study reports, support NDA/IND submissions, investigator related documents.
• Participate in proposal preparation and resource allocation
• Proactively manage timelines for medical writing deliverables
• Represent Medical Writing at bid defenses and internal meetings
• Assist in the development of key messaging and operational procedures
• Ability to review and understand client report templates and style guides
• Develop/maintain medical writing SOPs
• Perform quality control and peer reviews of documents and assess compliance with regulatory requirements, clients requests, and SOPs

Basic Qualifications:

• 8+ years of Medical Writing experience in the Pharma industry
• FDA submission experience
• 8+ years of writing experience in support of Oncology
• 8+ years of FDA and other regulatory Submission experience.
• CSR experience
• Client Interaction experience
• Strong MS Office skills
• Bachelor’s degree from an accredited university

Preferred Qualifications:

• Advanced degree from an accredited university