# Sponsor Dedicated - Sr. Principal Medical Writer - Regulatory Submission Docs (ISE/ISS/Clinical Overview - Must Have)

**Company**: Syneos Health
**Location**: USA-Remote
**Work arrangement**: remote
**Experience**: senior
**Job type**: full-time
**Salary**: $114,000.00 - $210,900.00
**Category**: Healthcare
**Industry**: Healthcare

**Apply**: https://syneoshealth.wd12.myworkdayjobs.com/en-US/Syneos_Health_External_Site/job/USA-Remote/Sponsor-Dedicated---Sr-Principal-Medical-Writer---Regulatory-Submission-Docs--ISE-ISS-Clinical-Overview---Must-Have-_25113374-1?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply
**Canonical**: https://yubhub.co/jobs/job_e4ab5ba5-b4f

## Description

Syneos Health is seeking a Sr. Principal Medical Writer to develop regulatory documents for submission to regulatory agencies globally. The successful candidate will have at least 5 years of medical writing experience in the biopharmaceutical/CRO industry and strong organizational, time management, and project management skills.

Responsibilities:

- Develop regulatory documents for submission to regulatory agencies globally, in accordance with ICH and other global guidelines, standards and processes

- Manage medical writing projects, including developing timelines and communication with cross-functional team members

- Participate in cross-functional meetings to provide input regarding medical writing deliverables, timelines, and processes

- Review other documents associated with assigned projects, such as Protocols and Statistical Analysis Plans

- Participate in cross-functional process improvement initiatives

- Mentor more junior medical writing staff

Requirements:

- Bachelor's degree required; advanced degree in a relevant scientific/clinical/regulatory field preferred

- At least 5 years of medical writing experience in the biopharmaceutical/CRO industry required

- Proficiency in organizing and communicating clinical information required with minimal oversight

- Strong organizational, time management, and project management skills required

- Proficient in MS Word; experience with an electronic document management system and templates required

Benefits:

- Company car or car allowance

- Health benefits, including Medical, Dental, and Vision

- Company match 401k

- Eligibility to participate in Employee Stock Purchase Plan

- Eligibility to earn commissions/bonus based on company and individual performance

- Flexible paid time off (PTO) and sick time

Salary Range: $114,000.00 - $210,900.00

## Skills

### Required
- medical writing
- regulatory documents
- ICH guidelines
- MS Word
- electronic document management system

### Nice to have
- oncology
- advanced degree in a relevant scientific/clinical/regulatory field

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Source: [Apply at syneoshealth.wd12.myworkdayjobs.com](https://syneoshealth.wd12.myworkdayjobs.com/en-US/Syneos_Health_External_Site/job/USA-Remote/Sponsor-Dedicated---Sr-Principal-Medical-Writer---Regulatory-Submission-Docs--ISE-ISS-Clinical-Overview---Must-Have-_25113374-1?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)