Director of Clinical Documentation

5 days ago


Atlanta, Georgia, United States Lifelancer Full time

We're excited to announce that Lifelancer has partnered with Eisai to offer a unique opportunity for medical writers to advance their careers. The Associate Director, Medical Writing role is a key position within the company's medical writing team.

About the Company

Eisai is a global pharmaceutical company dedicated to improving human health care. With a strong emphasis on research and development, we're constantly pushing the boundaries of what's possible in neurology and oncology.

Job Description

This role involves leading the preparation of clinical sections of submission documents, such as briefing books, Global Investigator Brochures, and annual regulatory reports. You'll work closely with cross-functional teams to develop document standards and structure, ensuring alignment and consistency across studies.

Responsibilities:
  • Management of complex projects, including document preparation and review
  • Liaison with clinical research and biostatistics staff to gain comprehensive understanding of study design and results
  • Implementation of document quality controls, standards, and best practices
Requirements

To be successful in this role, you'll need a BS degree (MS preferred) and at least 8-10 years of medical writing experience in an industry setting. A proven track record of managing large-scale projects, excellent communication skills, and a strong understanding of document management systems are essential.

What We Offer

In addition to competitive pay and benefits, we offer a dynamic work environment, opportunities for professional growth, and recognition for outstanding performance. If you're passionate about medical writing and eager to make a difference, please consider joining our team.



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