Senior Medical Writer

A company is looking for a Senior Medical Writer to prepare high-quality regulatory documents and serve as a subject matter expert.

Key Responsibilities

Lead medical writing on complex assignments and collaborate with teams on document strategies

Mentor junior medical writers and provide solutions during the writing process

Prepare and finalize various clinical study-related regulatory documents and external-facing materials

Required Qualifications

Bachelor's degree in a science-related field with 4+ years of relevant medical writing experience, or a master's degree with 2+ years of experience

Experience in NDA submissions and writing clinical study reports, Investigator's brochures, and study protocols

Strong scientific background in oncology, immunotherapy, or related fields

Proficient knowledge of AMA writing guidelines and FDA, EMA, and ICH regulations

Ability to work collaboratively in a dynamic environment and manage multiple projects