Job Description – Medical Writer / Medical Reviewer (Ovarian Cancer Oncology Expertise)
Position Title
Medical Writer / Medical Reviewer – Oncology (Ovarian Cancer)
Location
Remote / Hybrid
Position Summary
We are seeking an experienced Medical Writer or Medical Reviewer with expertise in Ovarian Cancer and Gynecologic Oncology to support the development, review, and delivery of high-quality scientific and medical content. The successful candidate will collaborate with Medical Affairs, Clinical Development, Regulatory Affairs, Biostatistics, and external experts to ensure scientific accuracy, compliance, and timely execution of deliverables. The role requires a strong understanding of ovarian cancer biology, treatment landscape, clinical trial data, and publication practices.
Key Responsibilities
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).
Required Qualifications
Education
- MD, PharmD, PhD, or Master's degree in Life Sciences, Oncology, Pharmacy, or related field.
- Advanced degree preferred.
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.