Medical Writing Lead with Pharmaceutical Expertise

1 week ago


Hartford, Connecticut, United States Lifelancer Full time
Job Summary

The Associate Director, Medical Writing will be the designated Lead Medical Writer for multiple Programs, responsible for providing needed support and direction to other staff/contractors on these programs.

This role ensures timely completion, accuracy and quality of all clinical and submission documentation across all aspects of the compounds' life cycle management.

Main Responsibilities:
  • Prepare and at times direct, the writing of PCSs, protocols and protocol amendments
  • Independently prepare and at times may direct, all the writing of the CSRs including narratives
  • Work across functional areas to obtain all applicable source materials
  • Lead the preparation of clinical sections of submission documents, such as the briefing books, Global Investigator Brochures, and annual regulatory reports
  • Liaise with other functional areas and groups in the development of document standards and structure
About the Company

Eisai is a growing pharmaceutical company that is breaking through in neurology and oncology, with a strong emphasis on research and development.

We're seeking highly-motivated individuals who want to work in a fast-paced environment and make a difference.

What We Offer

Competitive salary range: 149,200-195,800

Eligibility to participate in Eisai Inc. Annual Incentive Plan & Eisai Inc. Long Term Incentive Plan

Company employee benefit programs

Requirements
  • BS required/MS preferred
  • Minimum of 8-10 years medical writing experience in an industry setting, with specific experience with therapeutic area
  • Must have participated in or lead a major marketing application submission
  • Strong critical thinking and problem solving skills


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