Principal Medical Writer ( Regulatory Medical Writing docs)

Responsibilities

• Lead complex medical writing deliverables with clear, accurate scientific content

• Author protocols, CSRs, narratives, PSURs, DSURs, ICFs, IBs and regulatory submissions

• Define document strategy and coordinate writing activities across departments

• Lead resolution of client comments and document reviews

• Advise clients and study teams on data presentation and production strategies

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

• Mentor and lead less experienced medical writers

• Represent the medical writing department on study teams and at client meetings

Requirements

• 5+ years of regulatory medical writing experience

• Expertise authoring protocols, CSRs, narratives, PSURs, DSURs, ICFs and IBs

• Proven lead medical writer experience in a CRO environment

• Knowledge of ICH E3 guidelines and regulatory standards

• Minimal travel, less than 25%

Preferred Qualifications

• Experience with NDA and eCTD submissions

• Experience with journal manuscripts and scientific presentations

About the Company

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