# Principal Medical Writer - Publications

**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/CAN-Remote/Principal-Medical-Writer---Publications_25111239?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply
**Canonical**: https://yubhub.co/jobs/job_e6ca9661-d45

## Description

Syneos Health is seeking a Principal Medical Writer - Publications to lead the clear and accurate completion of complex medical writing deliverables. The successful candidate will have at least 6 years of relevant experience in science, technical, or medical writing, with extensive experience working in the biopharmaceutical, device, or contract research organization industry.

Responsibilities:

- Lead the completion of complex medical writing deliverables, ensuring scientific information is presented clearly and accurately

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

- Lead the resolution of comments from the client

- Complete a variety of documents, including clinical study protocols, clinical study reports, patient narratives, and abstracts

- 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

- Review statistical analysis plans and table/figure/listing specifications

- 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

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

Requirements:

- At least 6 years of relevant experience in science, technical, or medical writing

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

- Advanced understanding of FDA and ICH regulations and guidelines

- Extensive experience writing relevant document types

- Extensive knowledge of English grammar and ability to communicate clearly

## Skills

### Required
- medical writing
- regulatory standards
- clinical study protocols
- ICH E3 guidelines
- English grammar

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Source: [Apply at syneoshealth.wd12.myworkdayjobs.com](https://syneoshealth.wd12.myworkdayjobs.com/en-US/Syneos_Health_External_Site/job/CAN-Remote/Principal-Medical-Writer---Publications_25111239?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)