# Sponsor Dedicated - Sr Medical Writer (CSR, Protocols, IB and Reg documents)

**Company**: Syneos Health
**Experience**: senior
**Job type**: full-time
**Category**: Healthcare
**Industry**: Healthcare

**Apply**: https://syneoshealth.wd12.myworkdayjobs.com/en-US/Syneos_Health_External_Site/job/GRC-Remote/Sponsor-Dedicated---Sr-Medical-Writer--CSR--Protocols--IB-and-Reg-documents-_25112997?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply
**Canonical**: https://yubhub.co/jobs/job_d9170a5d-ab5

## Description

Syneos Health is seeking a Senior Medical Writer to lead the clear and accurate completion of medical writing deliverables, ensuring scientific information is presented clearly and accurately.

Responsibilities:

- Lead medical writing activities associated with individual studies, coordinating with minimal supervision

- Complete various documents, including clinical study protocols, clinical study reports, patient narratives, and more

- Adhere to established regulatory standards, such as ICH E3 guidelines and company SOPs

- Coordinate quality and editorial reviews, and ensure source documentation is managed appropriately

- Act as peer reviewer for internal team to ensure document scientific content, clarity, and consistency

- Interact and build good working relations with clients, department heads, and peers

- Perform online clinical literature searches and comply with copyright requirements

- Identify and propose solutions to resolve issues, escalating as necessary

- Mentor and lead less experienced medical writers on complex projects

- Develop deep expertise on key topics in the industry and regulatory requirements

- Manage budget specifications for assigned projects and communicate status and changes to leadership

Requirements:

- 3-5 years of relevant experience in regulatory writing

- Experience working in the biopharmaceutical, device, or contract research organization industry

- Strong understanding of EMA, FDA, and ICH regulations, and good publication practices

- Extensive knowledge of English grammar and ability to communicate clearly

- Familiarity with AMA Manual of Style

Benefits:

- Career development and progression opportunities

- Supportive and engaged line management

- Technical and therapeutic area training

- Peer recognition and total rewards program

- Inclusive culture

## Skills

### Required
- regulatory writing
- ICH E3 guidelines
- English grammar
- AMA Manual of Style
- EMA regulations
- FDA regulations

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Source: [Apply at syneoshealth.wd12.myworkdayjobs.com](https://syneoshealth.wd12.myworkdayjobs.com/en-US/Syneos_Health_External_Site/job/GRC-Remote/Sponsor-Dedicated---Sr-Medical-Writer--CSR--Protocols--IB-and-Reg-documents-_25112997?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)