# Principal Medical Writer (Regulatory Medical Writing docs)

**Company**: Syneos Health
**Location**: IND-Hyderabad-Hybrid
**Work arrangement**: hybrid
**Experience**: senior
**Job type**: full-time
**Category**: Healthcare
**Industry**: Healthcare

**Apply**: https://syneoshealth.wd12.myworkdayjobs.com/en-US/Syneos_Health_External_Site/job/IND-Hyderabad-Hybrid/Principal-Medical-Writer---Regulatory-Medical-Writing-docs-_25114174?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply
**Canonical**: https://yubhub.co/jobs/job_82542932-bdf

## Description

Syneos Health is seeking a Principal Medical Writer with 5+ years of regulatory medical writing experience. As a Principal Medical Writer, you will lead the clear and accurate completion of complex medical writing deliverables, ensuring scientific information is presented clearly and accurately.

Responsibilities:

- Lead the development of regulatory medical writing documents, including protocols, protocol amendments, CSRs, narratives, PSURs, DSURs, ICFs, and IBs

- Manage medical writing activities associated with individual studies, defining document strategy and coordinating medical writing activities within and across departments

- Complete a variety of documents, including clinical study protocols, clinical study reports, patient narratives, and periodic safety update reports

- Adhere to established regulatory standards, including ICH E3 guidelines and company standard operating procedures

- Advise clients and study teams on data presentation and production strategies

- Lead team document reviews and review documents for technical issues

- Serve as expert peer reviewer for internal team

- Interact and build good working relationships with clients, department head, and team members

- Perform online clinical literature searches and comply with copyright requirements

- Identify and propose solutions to resolve issues

- Mentor and lead less experienced medical writers on complex documents

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

- Aware of budget specifications for assigned projects and communicate status and changes to medical writing leadership

Benefits:

- Career development and progression opportunities

- Supportive and engaged line management

- Technical and therapeutic area training

- Peer recognition and total rewards program

- Inclusive culture

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## Skills

### Required
- regulatory medical writing
- protocols
- CSRs
- narratives
- PSURs
- DSURs
- ICFs
- IBs
- ICH E3 guidelines

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Source: [Apply at syneoshealth.wd12.myworkdayjobs.com](https://syneoshealth.wd12.myworkdayjobs.com/en-US/Syneos_Health_External_Site/job/IND-Hyderabad-Hybrid/Principal-Medical-Writer---Regulatory-Medical-Writing-docs-_25114174?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)