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

3 weeks, 4 days ago
United States
Contract
Senior
Technical Writer
Technical Writing and Documentation
GCP
Apply Now
ClinChoice

ClinChoice

ClinChoice is a leading full-service contract research organization (CRO) that provides high-quality solutions to clients in the pharmaceutical, biotechnology, medical device, and consumer products sectors, focusing on accelerating the development and ...

Professional Services
1K-5K
Founded 1995
View All Jobs 3

Description

  • Develop and review scientific and medical materials, including clinical study reports, protocols, investigator brochures, manuscripts, abstracts, posters, slide decks, educational materials, medical information responses, FAQs, congress presentations, and publication plans.
  • Summarize and interpret clinical data related to ovarian cancer therapies and biomarkers.
  • Ensure content consistency with ICH, GCP, GPP, company standards, and applicable regulatory requirements.
  • Conduct literature reviews and evidence synthesis using peer-reviewed journals and congress proceedings.
  • Collaborate with Medical Affairs, Clinical Development, Regulatory Affairs, Biostatistics, and external experts to support regulatory submissions and medical affairs activities.
  • Perform scientific and medical review of promotional and non-promotional materials for accuracy, balance, and compliance.
  • Support MLR review processes and provide expert input on ovarian cancer treatment guidelines and emerging therapies.
  • Monitor publications, clinical trials, and congress updates relevant to ovarian cancer and gynecologic oncology.

Requirements

  • MD, PharmD, PhD, or Master's degree in Life Sciences, Oncology, Pharmacy, or a 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.
  • Experience with clinical development, publications, and medical affairs deliverables.
  • Familiarity with ICH, GCP, GPP, FDA, EMA, and international regulatory requirements.
  • Strong working knowledge of epithelial ovarian cancer, platinum-sensitive and platinum-resistant disease, BRCA and HRD biomarkers, PARP inhibitors, antibody-drug conjugates, and immuno-oncology approaches.
  • Familiarity with NCCN, ESMO, and ASCO treatment guidelines, as well as congresses such as ASCO, ESGO, SGO, and ESMO.
  • Preferred experience supporting ovarian cancer assets or clinical trials.
  • Preferred publication experience with manuscripts, abstracts, and posters.
  • Preferred experience participating in MLR review processes.
  • Familiarity with EndNote, PubMed, Veeva Vault, and reference management tools is preferred.

Interested in this position?

Apply directly on the company website

Apply Now

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