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Senior Clinical Documentation Specialist

1 semana atrás

Lisboa, Lisboa, Portugal Syneos Health, Inc. Tempo inteiro

**Job Summary**

We are seeking a highly skilled Senior Clinical Documentation Specialist to join our team at Syneos Health, Inc. As a key member of our regulatory medical writing department, you will be responsible for reviewing statistical analysis plans and table/figure/listing specifications for appropriate content, and for grammar, format, and consistency.

**Key Responsibilities**

  • Review statistical analysis plans and table/figure/listing specifications
  • Ensure accuracy and consistency in document content
  • Interact with department head and staff members in data management, biostatistics, regulatory affairs, and medical affairs as necessary
  • Serve as peer reviewer on internal review team providing review comments on draft and final documents

**Requirements**

  • Bachelor of Science degree with relevant writing experience or Bachelor of Arts degree in Social Sciences, English, or Communications with relevant scientific and/or medical knowledge and expertise
  • Extensive knowledge of English grammar and FDA and ICH regulations and guidelines
  • Demonstrated high degree of independence with effective presentation, proofreading, interpersonal, and leadership skills

**About Us**

Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs, and commercial insights into outcomes to address modern market realities.