Medical Writer / Medical Reviewer Consultant – Oncology (Ovarian Cancer)
ClinChoice · New York, NY · 1 mo ago
RemoteRemoteMarketingFull-time
Key Responsibilities
- Develop and review scientific and medical materials, including:
- Clinical study reports (CSRs)
- Protocols and amendments
- Investigator brochures
- Manuscripts, abstracts, and posters
- Slide decks and educational materials
- Medical information responses and FAQs
- Congress presentations and publication plans
- Summarize and interpret clinical data related to ovarian cancer therapies and biomarkers.
- Ensure consistency with ICH, GCP, GPP, and company standards.
- Conduct literature reviews and evidence synthesis from peer-reviewed journals and congress proceedings.
- Collaborate with cross-functional teams to support regulatory submissions and medical affairs activities.
Scientific Expertise
- Maintain current knowledge of:
- Epithelial ovarian cancer
- Platinum-sensitive and platinum-resistant disease
- BRCA and HRD biomarkers
- PARP inhibitors
- Antibody-drug conjugates
- Immuno-oncology approaches
- NCCN, ESMO, and ASCO treatment guidelines
- Monitor publications, clinical trials, and congress updates (ASCO, ESGO, SGO, ESMO).
Required Qualifications
- Education: MD, PharmD, PhD, or Master's degree in Life Sciences, Oncology, Pharmacy, or related field.
- Experience: 3–8+ years of medical writing or medical review experience in pharmaceutical, biotechnology, CRO, or medical communications environments.
- Demonstrated expertise in Oncology, with significant experience in Ovarian Cancer.
- Experience with clinical development, publications, and medical affairs deliverables.
- Familiarity with ICH, GCP, GPP, FDA, EMA, and international regulatory requirements.
Preferred Qualifications
- Experience supporting ovarian cancer assets or clinical trials.
- Knowledge of biomarker-driven therapies and companion diagnostics.
- Publication experience (manuscripts, abstracts, posters).
- Experience participating in MLR review processes.
- Familiarity with EndNote, PubMed, Veeva Vault, and reference management tools.