Role Overview

This position is for an experienced medical writer or medical reviewer who brings deep expertise in ovarian cancer and gynecologic oncology. The selected professional will help create, assess, and deliver scientifically rigorous content while partnering with Medical Affairs, Clinical Development, Regulatory Affairs, Biostatistics, and external subject-matter experts. The role calls for a strong grasp of ovarian cancer biology, the treatment landscape, clinical trial evidence, and publication standards.
Core Responsibilities
• Draft, edit, and evaluate scientific and medical content across a range of deliverables, such as clinical study reports, study protocols and amendments, investigator brochures, manuscripts, abstracts, posters, slide decks, educational assets, medical information responses, FAQs, congress materials, and publication planning documents.
• Distill and explain clinical evidence related to ovarian cancer therapies and biomarkers in a clear, accurate manner.
• Align all written output with ICH, GCP, GPP, and internal quality standards.
• Perform literature searches and synthesize evidence from journals and congress materials.
• Work closely with cross-functional teams to support regulatory submissions and medical affairs activities.
• Carry out scientific and medical review of both promotional and non-promotional materials.
• Check references, claims, and clinical statements for accuracy, balance, and regulatory compliance.
• Support medical-legal-regulatory review workflows.
• Provide expert guidance on ovarian cancer treatment guidelines and emerging therapies.
Scientific Focus
• Stay current on epithelial ovarian cancer, including platinum-sensitive and platinum-resistant disease.
• Maintain knowledge of BRCA and HRD biomarkers, PARP inhibitors, antibody-drug conjugates, and immuno-oncology approaches.
• Track guidance from NCCN, ESMO, and ASCO.
• Monitor updates from major scientific meetings and publications, including ASCO, ESGO, SGO, and ESMO.
Qualifications
• Advanced degree in medicine, pharmacy, life sciences, oncology, or a related discipline, such as MD, PharmD, PhD, or a master's degree.
• Higher-level academic training is preferred.
• At least 3 to 8+ years of experience in medical writing or medical review within pharmaceutical, biotechnology, CRO, or medical communications settings.
• Substantial oncology background, with meaningful hands-on experience in ovarian cancer.
• Exposure to clinical development, publication support, and medical affairs documentation.
• Working familiarity with ICH, GCP, GPP, FDA, EMA, and other international regulatory expectations.
Preferred Experience
• Experience supporting ovarian cancer programs or clinical trials.
• Understanding of biomarker-based therapies and companion diagnostics.
• Prior work on manuscripts, abstracts, and posters.
• Background in medical-legal-regulatory review processes.
• Comfort using EndNote, PubMed, Veeva Vault, and similar reference management tools.
Location

This role is listed as remote or hybrid.

Responsibilities
• Create and refine scientific and medical materials including reports, protocols, investigator brochures, publications, educational content, and congress assets.
• Summarize ovarian cancer data and biomarkers with scientific accuracy.
• Ensure all deliverables meet applicable scientific, regulatory, and company standards.
• Conduct evidence reviews using peer-reviewed literature and congress proceedings.
• Partner with internal functions and external experts to support submissions and medical affairs work.
• Review promotional and non-promotional materials for medical accuracy, consistency, and compliance.
• Check clinical claims, citations, and references for balance and correctness.
• Contribute to MLR review activities.
• Advise on treatment guidelines and new developments in ovarian cancer.

Requirements
• MD, PharmD, PhD, or master's degree in life sciences, oncology, pharmacy, or a similar field.
• Advanced qualification is preferred.
• 3–8+ years of relevant medical writing or medical review experience in pharma, biotech, CRO, or medical communications.
• Strong oncology experience, especially in ovarian cancer.
• Background in clinical development, publication work, and medical affairs deliverables.
• Knowledge of ICH, GCP, GPP, FDA, EMA, and broader regulatory requirements.