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