Clinical Development Specialist Lead

hace 18 horas


Barcelona, Barcelona, España Syneos - Clinical and Corporate - Prod A tiempo completo

About Our Company

Syneos Health - Clinical and Corporate - Prod is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success.

About the Job

In this role, you will be responsible for developing good working relationships with internal and external colleagues, managing medical writing activities associated with individual studies, and coordinating medical writing activities within and across departments with minimal supervision.

You will develop various documents, including clinical study protocols and clinical protocol amendments, clinical study reports, patient narratives, clinical development plans, IND submissions and annual reports, integrated summary reports, NDA and (e)CTD submissions, investigator brochures, clinical journal manuscripts, clinical journal abstracts, and client presentations.

Requirements

  • Bachelor of Science degree with relevant writing experience or Bachelor of Arts degree (Social Sciences, English or Communications, preferred) with relevant scientific and/or medical knowledge and expertise.
  • Extensive knowledge of English grammar with a familiarity with AMA style guide.
  • Understanding of FDA and ICH regulations and guidelines strongly preferred.
  • Demonstrated effective presentation, proofreading, and interpersonal skills and ensure a team-oriented approach.
  • Strong proficiency in Word, Excel, PowerPoint, email, and Internet.
  • Ability to demonstrate a familiarity with principles of clinical research and to interpret and present clinical data and other complex information.

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