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

Industrials

1K-5K (1750)

Founded 1995

3 open positions

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

3 months, 3 weeks ago

United States

Contract

Senior

Technical Writer

Technical Writing and Documentation

GCP

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ClinChoice

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

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