Sr. Medical Writer - CRO & Clinical Operations

Posted 10 May 2023
Salary Competitive
LocationUnited States of America
Job type Full Time
Discipline CRO & Clinical Operations
Contact NameStephanie Moreno

Job description

​Mantell Associates is currently partnered with a leading Global CRO on an exciting opportunity available for a Senior Medical Writer.

 

  • Are you looking to join a leading international CDMO?

  • Do you have extensive experience in medical writing, with a focus on clinical research?

  • Do you enjoy new challenges and want to develop your career?

​This company is focused purely within the Neurosciences space in early phase trials. They are looking for a Senior Medical Writer who will be responsible for creating high-quality clinical and regulatory documents to support the development and submission of pharmaceutical products.

 

Senior Medical Writer Responsibilities:

  •  Collaborate with cross-functional teams, including clinicians, biostatisticians, and regulatory affairs professionals, to develop and write clinical study reports, protocols, investigator brochures, and other regulatory documents

  • Conduct literature reviews and gather relevant data to support the development of clinical documents

  • Interpret and summarize complex scientific and clinical data into clear, concise, and accurate content

  • Collaborate with internal stakeholders to ensure timely delivery of high-quality documents

  • Provide guidance and mentorship to junior medical writers as needed

Senior Medical Writer Requirements:

  •  Bachelor's or advanced degree in a scientific or medical field

  • Minimum of 5 years of experience in medical writing within the pharmaceutical or CRO industry

  • Thorough understanding of clinical research processes and regulatory requirements (ICH, FDA)

  • Strong attention to detail and ability to critically analyze and interpret scientific data

  • Proficiency in using medical writing software and document management systems

 

Mantell Associates is a specialist Pharmaceutical and Life Sciences headhunting firm. For more information on this role, please contact Stephanie Moreno at 786-431-3404 or stephanie.moreno@mantellassociates.com.