Description

You will lead the development and delivery of high-quality scientific and regulatory documents supporting Olea's oncology portfolio. You will collaborate cross-functionally to translate complex clinical data into compelling content for submissions and publications, driving consistency and quality across deliverables.

Requirements

• Bachelor's in life sciences (advanced degree preferred)
• 7+ years medical/regulatory writing experience, oncology preferred
• Excellent scientific writing and editing skills
• Familiarity with ICH E3/E6 and GPP
• Strong project management and cross-functional collaboration skills

Responsibilities

• Prepare and edit protocols, investigator brochures, regulatory submission documents (IBs, DSURs, IND/IMPD/MAAs sections)
• Collaborate with internal stakeholders to interpret data and ensure accurate message conveyance
• Ensure documents adhere to internal style guidelines and regulatory requirements (ICH, GPP)
• Maintain version control, track feedback, and deliver documents on time
• Provide QC editing support for submission documents