Sponsor Dedicated Senior Medical Writer (Regulatory Submission Documents)- US Remote Based

Responsibilities

• Lead medical writing deliverables for protocols and protocol amendments

• Manage medical writing activities across individual studies with minimal supervision

• Lead resolution of client comments and quality and editorial reviews

• Author clinical study reports, IND submissions, NDA and eCTD submissions, and plain language summaries

• Ensure adherence to ICH E3, FDA standards, SOPs and client templates

• Peer review statistical analysis plans and table, figure and listing specifications

• Mentor less experienced medical writers on complex projects

• Minimal travel may be required (less than 25%)

Requirements

• 3-5 years of medical writing experience, including protocol writing

• Experience in biopharmaceutical, device, or CRO industry

• Strong understanding of FDA and ICH regulations

• Experience with late development and oncology, hematology or cell therapy

• Experience with Veeva or CARA

• Extensive English grammar knowledge and familiarity with AMA Manual of Style

Preferred Qualifications

• Experience writing relevant regulatory document types

Benefits

• Health benefits including medical, dental and vision

• Company 401k match and Employee Stock Purchase Plan

• Commissions or bonus based on performance

• Flexible paid time off and sick time

About the Company

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