Sr./Principal Medical Writer (Regulatory focus)

Responsibilities

• Lead completion of medical writing deliverables for individual studies

• Author protocols, clinical study reports, patient narratives, IBs, and regulatory submissions

• Coordinate quality and editorial reviews and resolve client comments

• Review statistical analysis plans and table/figure/listing specifications

• Mentor less experienced medical writers on complex projects

• Manage project budgets, hours, and timelines

Requirements

• Minimum 5 years of lead regulatory writing experience

• Experience with Phase 2 and 3 studies

• Lead writing experience with protocols, CSRs, IBs, and ISE/ISS

• Strong project management and client experience

• Strong time management skills

Preferred Qualifications

• Process experience

Benefits

• Career development, training, and total rewards program

About the Company

Syneos Health is a fully-integrated life sciences services organization accelerating customer success across drug development and commercialization.