Executive Medical Writing Lead

15 hours ago


Durham, North Carolina, United States Lifelancer Full time

About Eisai

Eisai is a growing pharmaceutical company that prioritizes research and development, particularly in neurology and oncology. Our mission is to satisfy unmet medical needs and increase the benefits healthcare provides to patients, their families, and caregivers.

Job Overview

We are seeking an experienced Executive Medical Writing Lead to join our team. As a key member of our medical writing team, you will be responsible for providing high-quality clinical and submission documentation across all aspects of the compounds' life cycle management.

Key Responsibilities:

  • Lead Medical Writer: Serve as the designated lead writer for multiple programs, ensuring timely completion, accuracy, and quality of all clinical and submission documentation.
  • Complex Problem-Solving: Analyze complex problems, requiring in-depth evaluation of various factors, to deliver effective solutions.
  • Document Preparation: Independently prepare and direct the writing of PCSs, protocols, and protocol amendments, as well as clinical sections of submission documents.
  • Collaboration: Work closely with clinical research and biostatistics staff to gain comprehensive understanding of study design and results across the program.
  • Quality Control: Implement document quality controls, standards, and best practices to ensure exceptional quality.

Requirements:

  • Education: Bachelor's degree required, Master's degree preferred.
  • Experience: Minimum 8-10 years of medical writing experience in an industry setting, with specific experience in the therapeutic area.
  • Leadership Experience: Participated in or led a major marketing application submission.
  • Critical Thinking: Strong critical thinking and problem-solving skills.
  • Self-Motivation: Self-motivated with the ability to influence others.
  • Multitasking: Ability to multitask on complex projects.
  • Time Management: Result-driven with mastery of time management and project planning.

Benefits and Compensation

The estimated annual salary for this position is between $149,200-$195,800, based on industry standards and market conditions. This role is eligible to participate in the Eisai Inc. Annual Incentive Plan and Eisai Inc. Long Term Incentive Plan.

Other Information

Eisai is an equal opportunity employer and is committed to diversity and inclusion. We participate in E-Verify and follow all applicable employment laws and regulations.



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