Medical Writer Lead

hace 2 semanas


Sevilla, Sevilla, España Pharmiweb A tiempo completo
Senior Medical Writer Job Description

We are seeking a highly skilled and experienced Senior Medical Writer to join our team at Syneos Health. As a Senior Medical Writer, you will be responsible for leading and mentoring less experienced medical writers on complex projects, as well as managing medical writing activities associated with individual studies.

Key Responsibilities:
  • Lead and mentor less experienced medical writers on complex projects
  • Manage medical writing activities associated with individual studies
  • Develop and support a variety of documents, including clinical study protocols, clinical study reports, and patient narratives
  • Identify and propose solutions to resolve issues and questions arising during the writing process
  • Review statistical analysis plans and table/figure/listing specifications for appropriate content and grammar
  • 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
  • Adhere to established regulatory standards, including ICH-E3 guidelines, and Company Standard Operating Procedures
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 and FDA and ICH regulations and guidelines
  • Demonstrated high degree of independence with effective presentation, proofreading, interpersonal, and leadership skills
  • 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
About Syneos Health:

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. Our Clinical Development model brings the customer and the patient to the center of everything that we do.

We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals.

We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives. Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE


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