Senior Medical Writer (Oncology, On-site)

Job summary

The role involves working as a Senior Medical Writer focused on oncology clinical trials, requiring collaboration with medical monitors and senior leadership. The position entails managing the full life-cycle of regulatory medical writing processes.

Qualifications

• Bachelor’s degree required; advanced degree preferred.
• Minimum of 5 years of experience in a CRO or pharmaceutical environment.
• At least 3 years of relevant experience in regulatory medical writing, specifically in oncology.
• Experience as a lead writer on a minimum of 3 Clinical Study Protocols, Clinical Study Reports, Investigator’s Brochures, Development Safety Update Reports, or IND applications.

Responsibilities

• Prepare various regulatory documents including IND applications, clinical study protocols, investigator's brochures, and clinical study reports.
• Provide guidance and support to in-house units for document preparation and review.
• Serve as a resource for new medical writers.

Skills

• Strong oral and written communication skills.
• Excellent interpersonal skills and advanced proficiency in MS Office Suite.
• Ability to work independently and manage multiple projects simultaneously.

Education

• Bachelor’s degree required; advanced degree preferred.

Tools

• Familiarity with eCTD modules and industry principles of drug safety, regulatory guidelines, and clinical trial methodology.