Job Summary
A healthcare services company is searching for a person to fill their position for a Telecommuting Oncology Senior Medical Writer.
Individual must be able to fulfill the following responsibilities:
- Provide more complex advanced input for study designs, analysis plans, sections of INDs and marketing applications
- Represent Medical Writing on cross-functional teams and task forces
- Serve as lead writer for important regulatory response documents and key components of regulatory submissions
Must meet the following requirements for consideration:
- Coordinates the activities, contract employees and vendors (on-site or external)
- At least 5 years experience writing for pharma or biotechnology required
- 3+ years of electronic documents and submissions required
- Bachelor's degree in science, health profession, or journalism required
- Experience as lead writer for key documents included in major US and/or international regulatory submissions required
- Clear understanding of clinical development, including the phases, processes, and techniques used within a clinical development environment
