Medical Writer I

Responsibilities

• Compile, write, edit and coordinate medical writing deliverables presenting scientific information clearly and accurately

• Complete protocols, protocol amendments, clinical study reports, patient narratives and investigator brochures

• Adhere to ICH E3 guidelines, SOPs, client standards and templates on time and on budget

• Coordinate quality and editorial reviews and resolve client comments

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

• Perform online clinical literature searches and comply with copyright requirements

• Manage assigned project budgets and communicate status to medical writing leadership

Requirements

• Medical writing experience in the clinical or regulatory domain

• Knowledge of ICH E3 and regulatory documentation standards

• Strong writing, editing and attention to detail

• Ability to work with clients, department heads and peers

Preferred Qualifications

• Familiarity with clinical study documents and statistical outputs

Benefits

• Career development and progression, technical and therapeutic training, total rewards program

About the Company

Syneos Health is a fully-integrated life sciences services organization partnering with innovators across drug development and commercialization.