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ClinChoice - Medical Writer / Medical Reviewer Consultant – Oncology (Ovarian Cancer)

United States - Hybrid4d ago

In Office Mid NA Pharmaceuticals Biotechnology CRO Physician Performance Reviews Reporting CRO Clinical Trials GCP Vault

Requirements

• Education • MD, PharmD, PhD, or Master's degree in Life Sciences, Oncology, Pharmacy, or related field. • Advanced degree preferred. • 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. • Oncology • Ovarian Cancer • Experience with clinical development, publications, and medical affairs deliverables. • Familiarity with ICH, GCP, GPP, FDA, EMA, and international regulatory requirements. • 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.

Responsibilities

• Medical Writing • Medical Writing • 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. • Medical Review • Perform scientific and medical review of promotional and non-promotional materials. • Verify scientific accuracy, consistency, and compliance with regulatory requirements. • Review clinical data, references, and claims for accuracy and balance. • Support MLR (Medical-Legal-Regulatory) review processes. • Provide expert input regarding ovarian cancer treatment guidelines and emerging therapies. • 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).