# Medical Writer I (CSR Narrative)

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

**Apply**: https://syneoshealth.wd12.myworkdayjobs.com/en-US/Syneos_Health_External_Site/job/IND-Hyderabad-Hybrid/Medical-Writer-I--CSR-Narrative-_25113241?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply
**Canonical**: https://yubhub.co/jobs/job_b049f64d-748

## Description

Syneos Health is seeking a Medical Writer I (CSR Narrative) to join their Clinical Solutions team. The successful candidate will compile, write, and edit medical writing deliverables, serving as a medical writer within and across departments with moderate supervision.

**Job Responsibilities**

- Develops or supports a variety of documents, including clinical study protocols and amendments, clinical study reports, patient narratives, and investigator brochures.

- Reviews statistical analysis plans and table/figure/listing specifications for content, grammar, format, and consistency.

- Interacts with department heads and staff members in data management, biostatistics, regulatory affairs, and medical affairs to produce writing deliverables.

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

- Performs online clinical literature searches and continues professional development to keep pace with regulatory guidance and client expectations.

- Is aware of budget specifications for assigned projects and works within budgeted hours.

**Qualification Requirements**

- Bachelor of Science degree with relevant writing experience or Bachelor of Arts degree with relevant scientific and/or medical knowledge and expertise.

- Extensive knowledge of English grammar with familiarity with AMA style guide.

- Understanding of FDA and ICH regulations and guidelines strongly preferred.

- Demonstrated effective presentation, proofreading, and interpersonal skills.

- Strong proficiency in Word, Excel, PowerPoint, email, and internet.

**What Syneos Health Offers**

- 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
- medical writing
- narrative writing
- clinical study protocols
- clinical study reports
- patient narratives
- investigator brochures
- statistical analysis plans
- ICH-E3 guidelines
- AMA style guide
- Word
- Excel
- PowerPoint

### Nice to have
- FDA regulations
- ICH regulations
- regulatory affairs
- medical affairs
- data management
- biostatistics

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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/Medical-Writer-I--CSR-Narrative-_25113241?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)