Remote eCTD Regulatory Publishing Specialist

Syneos Health, Inc.; Remote; GBP 60,000 - 80,000; Full time

Job summary

A renowned healthcare solutions company seeks a Regulatory Publishing Specialist (eCTD) to oversee the publishing of regulatory data and ensure compliance with established procedures. The ideal candidate should have experience in the regulatory environment, strong organizational skills, and proficiency in various publishing software. Responsibilities include document quality control, assembling client submissions, and managing multiple projects simultaneously. This role offers competitive benefits, including health insurance and flexible paid time off.

Benefits

Company car or car allowance

Health benefits (medical, dental, vision)

401k company match

Employee Stock Purchase Plan

Flexible paid time off (PTO)

Qualifications

• Moderate experience in a regulatory environment, preferably in drug/device/biologic industry.
• Strong attention to detail and accuracy in publishing tasks.
• Ability to work independently and multitask multiple projects.

Responsibilities

• Perform QC on the published output and internal documentation.
• Handle publishing tasks in the electronic publishing system.
• Provide guidance to entry-level publishers on documentation.

Skills

Moderate experience in a regulatory environment

Working knowledge of basic computer applications

Knowledge of medical/scientific terminology

Strong communication, organizational, and interpersonal skills

Attention to detail and accuracy

Tools

Extedo eCTDManager

eSUBmanager

CoreDossier

ISI Toolbox

eCTDXpress

eValidator

Acrobat

Job description

A renowned healthcare solutions company seeks a Regulatory Publishing Specialist (eCTD) to oversee the publishing of regulatory data and ensure compliance with established procedures. The ideal candidate should have experience in the regulatory environment, strong organizational skills, and proficiency in various publishing software. Responsibilities include document quality control, assembling client submissions, and managing multiple projects simultaneously. This role offers competitive benefits, including health insurance and flexible paid time off.