Director of Clinical Content Creation

3 weeks ago


Morristown, Tennessee, United States Lifelancer Full time

Lifelancer, a leading talent-hiring platform in Life Sciences and Pharma, seeks an experienced Associate Director, Medical Writing to join our team. This role is ideal for individuals who want to work in a fast-paced environment and make a difference in the development of innovative medicines.

In this position, you will serve as the Lead Medical Writer for multiple Programs, responsible for providing support and direction to staff/contractors on these programs. You will ensure timely completion, accuracy, and quality of all clinical and submission documentation across all aspects of the compounds' life cycle management.

Key Responsibilities:

  • Complex Problem-Solving: Works on complex problems requiring in-depth evaluation of various factors.
  • Clinical Documentation: Independently prepares and directs the writing of PCSs, protocols, and protocol amendments.
  • CSR Preparation: Independently prepares and directs the writing of CSRs, including narratives.
  • Collaboration: Works across functional areas to obtain source materials.
  • Submission Documents: Leads the preparation of clinical sections of submission documents.
  • Document Standards: Liaises with other functional areas to develop document standards and structure.

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.
  • Marketing Application Submission: Must have 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.

Compensation and Benefits:

We offer a competitive salary range of $149,200 - $195,800 per annum, depending on experience level, education, knowledge, and skills. The position is eligible to participate in Eisai Inc.'s Annual Incentive Plan and Long-Term Incentive Plan. Additionally, employees are eligible to participate in Company employee benefit programs. For more information, please visit our website.



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