# Principal / Sr Principal Medical Writer (Regulatory Submission)

**Company**: Syneos Health
**Location**: IND-Remote
**Work arrangement**: remote
**Experience**: senior
**Job type**: full-time
**Category**: Healthcare
**Industry**: Healthcare

**Apply**: https://syneoshealth.wd12.myworkdayjobs.com/en-US/Syneos_Health_External_Site/job/IND-Remote/Senior---Principal-Medical-Writer--Regulatory-Submission--_25114044?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply
**Canonical**: https://yubhub.co/jobs/job_4b718e15-793

## Description

Syneos Health is seeking a Principal/Sr Principal Medical Writer (Regulatory Submission) to develop regulatory documents for submission to regulatory agencies globally.

The successful candidate will manage medical writing projects, participate in cross-functional meetings, and mentor junior medical writing staff.

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

- Participate in defining and writing standard operating procedures and best practices for efficient preparation of quality documents

- Manage internal and contract medical writing resources to ensure timely completion of assigned projects

- Mentor more junior medical writing staff

Syneos Health offers a range of benefits, including career development and progression, supportive line management, technical and therapeutic area training, and a total rewards program.

The company is committed to its Total Self culture, which encourages authenticity and inclusivity.

## Skills

### Required
- medical writing
- regulatory submissions
- ICH guidelines
- cross-functional collaboration

---

Source: [Apply at syneoshealth.wd12.myworkdayjobs.com](https://syneoshealth.wd12.myworkdayjobs.com/en-US/Syneos_Health_External_Site/job/IND-Remote/Senior---Principal-Medical-Writer--Regulatory-Submission--_25114044?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)