Sr. Principal Medical Writer - Regulatory Submission Docs (ISE/ISS/Clinical Overview - Must Have) - Oncology Preferred
$95,000–$210,900 year
Remote · California, United States or Arizona, United States
Job Summary
Senior Medical Writer responsible for developing regulatory documents for global submissions (IBs, CSRs, and marketing authorization submission documents) with minimal oversight; provides strategic direction to cross-functional teams, leads writers on summary documents, mentors junior staff, and ensures timely delivery of high-quality, data-driven documents aligned with ICH/global guidelines; manages internal and contract medical writing resources, participates in cross-functional meetings and process improvements, and writes or guides SOPs for efficient preparation of quality documents; requires ability to organize complex clinical data, apply regulatory standards, and communicate effectively across teams in a fast-paced, global environment; oncology knowledge preferred and responsibilities include defining timelines, coordinating with study teams, and ensuring compliance with global regulatory requirements.
Required Qualifications
- Bachelor's degree required
- Advanced degree in a relevant scientific/clinical/regulatory field preferred
- At least 5 years of medical writing experience in the biopharmaceutical/CRO industry required or comparable experience within clinical or preclinical development
- Proficiency in MS Word
- Experience with electronic document management systems and templates
- Strong organizational, time management, and project management skills
- Strong verbal, written, and interpersonal communication skills
- Knowledge of global regulatory requirements and therapeutic areas in all phases of clinical development desired
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