Medical Writer / Medical Reviewer (Oncology)

TL;DR

Medical Writer / Medical Reviewer (Oncology): Developing and reviewing high-quality scientific and medical content for ovarian cancer therapies with an accent on clinical study reports, regulatory submissions, and publication materials. Focus on ensuring scientific accuracy, compliance with regulatory standards, and interpreting complex clinical trial data within the gynecologic oncology landscape.

Location: Must be based in the United States (Remote/Hybrid)

Company

hirify.global is a global clinical research organization providing comprehensive services to the pharmaceutical and biotechnology industries.

What you will do

• Develop and review clinical study reports, protocols, and investigator brochures.
• Create scientific manuscripts, abstracts, posters, and educational slide decks.
• Perform scientific and medical review of promotional and non-promotional materials.
• Interpret and summarize clinical data related to ovarian cancer therapies and biomarkers.
• Collaborate with cross-functional teams including Medical Affairs, Regulatory, and Biostatistics.
• Support MLR (Medical-Legal-Regulatory) review processes to ensure compliance.

Requirements

• Must be based in the United States.
• Advanced degree (MD, PharmD, PhD, or Master's) in Life Sciences, Oncology, or Pharmacy.
• 3–8+ years of medical writing or review experience in pharma, biotech, or CRO environments.
• Demonstrated expertise in Oncology, specifically with Ovarian Cancer.
• Strong understanding of ICH, GCP, GPP, and FDA/EMA regulatory requirements.
• Experience with clinical development, publications, and medical affairs deliverables.

Nice to have

• Experience with biomarker-driven therapies and companion diagnostics.
• Proficiency with tools like EndNote, PubMed, and Veeva Vault.
• Proven track record in publication planning and congress presentations.

Culture & Benefits

• Opportunity to work on high-impact oncology assets.
• Collaborative environment with cross-functional global teams.
• Exposure to cutting-edge research in PARP inhibitors and immuno-oncology.