An opportunity has arisen with a biotech within the San Francisco area for 2x Medical Writers in the Regulatory space.

This is a excellent opportunity for a candidate looking for progressive growth within an emergency biotech who in 2020/2021 will be filling an NDA. This role is reporting into the Head of the Medical Writing team.

Key Responsabilities

• Producing Regulatory documents such as Study Reports, Investigator’s Brochures and regulatory submission modules according to department guidelines
• Perform quality control reviews of documents and work to GCP standards
• Simultaneously manages multiple overlapping projects at different stages and on separate development programs and contributes to overall process improvement

• Must possess the ability to manage large projects with minimal supervision
• Must possess the ability to coordinate production of deliverables and provide leadership to a project team
• Must possess independence in decision making and problem solving
• Must demonstrate an ability to serve as a departmental resource for training, mentoring, and the development of process improvements for Medical Writing

Qualifications

• BS/BA in a scientific discipline(or licensed certification)

This role is actively interviewing so in order to apply please email your CV through for consideration: s.banks@hamlynwilliams.com