Associate Director/Director, Medical Writing

San Francisco, CA; Boulder, CO; or Cambridge UK | Full Time | Clinical Development

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Job Description

Job Summary:

The Associate Director/Director, Medical Writing (AD/DMW) will manage and oversee the medical writing function across functional areas and project teams.

Role and Responsibilities:

  • Partner with clinical science to write clinical documents
  •  Identify, select, and manage suitable vendors when appropriate, and select vendor based on evaluation of services offered
  •  Manage the medical writing team
  •  Oversee medical writing vendors
  •  Develop a series of templates for key clinical documents, including protocol synopsis, protocol, clinical study report, investigator report etc.
  • Formatting large documents with multiple review cycles and tight deadlines

Education and Experience:

  •  Extensive experience of writing clinical documents within the pharmaceutical industry
  •  Clinical oncology experience required.  Must be familiar with the standard oncology clinical trial endpoints and terminology
  •  Understanding of clinical study design and drug development process
  •  Previous management of staff and mentoring experience
  •  Excellent writing skills, meticulous attention to detail
  •  Knowledge of GCP and ICH Guidelines
  •  Expert user of MS Word and PowerPoint
  •  Flexibility to work with colleagues in a global setting

Skills & Requirements

Qualifications:

  • The successful candidate will be a confident person keen to take responsibility for assigned activities
  •  Clinically related science degree preferred; other advanced degrees and/or relevant experience will also be considered
  •  Although plenty of support will be available, the AD/DMW will be expected to function independently, and would thrive in a mentored rather than a directed environment
  •  The AD/DMW will be able to take on new and varied activities and will enjoy participating at every level of the project, ranging from detailed review of documents/data through to strategic program planning
  •  The AD/DMW will be committed to working within a project team structure, will be an excellent collaborator and negotiator and will be able to manage other functions through a matrix structure
  •  The AD/DMW will be able to embrace the challenges and opportunities offered in a small company environment and to capitalize on the experience to develop skills and attain career goals

Working Conditions:

  • Office based position with minimal travel required
  •  Flexible work schedule to enable international communication