Job Title

My client is a full-service CRO specializing in oncology, conducting early and late-phase clinical trials across the U.S., Europe, and Asia. Established in 1982 with the award of the Clinical Trials Monitoring Contract for the National Cancer Institute (NCI), my client has maintained a strong and ongoing collaboration with NCI, forming the foundation of its operations.With a dedicated focus on cancer research, my client has an in-depth understanding of oncology science and the complexities of transitioning therapies from preclinical to clinical development. To date, they have designed and managed over 250 oncology trials, striving to ensure that new cancer treatments have the best opportunity to benefit patients worldwide. Their vision is to enhance cancer treatment and transform it into a manageable disease.Role Overview:My client is seeking a highly collaborative Senior Medical Writer with 5+ years of experience to join their team. This role is ideal for a self-starter who wants to be involved in the full regulatory medical writing lifecycle.Key ResponsibilitiesAs a Senior Medical Writer, you will be responsible for preparing a range of regulatory and clinical documents, including:Initial Investigational New Drug (IND) applications and amendmentsClinical study protocols and protocol amendmentsInvestigators brochures and updatesInterim and final clinical study reportsIND annual reportsDevelopment Safety Update Reports (DSURs)Patient informed consent formsProviding guidance and support to internal teams on manuals, training guidelines, and related documentsActing as a mentor and resource for junior medical writersExperience:Minimum 5 years of experience in a CRO or pharmaceutical environmentAt least 3 years of experience in regulatory medical writing (oncology experience preferred)Lead writer experience on at least three of the following:Clinical Study ProtocolsClinical Study ReportsInvestigators BrochuresDevelopment Safety Update ReportsIND ApplicationsInformed Consent FormsExperience working directly with clients or sponsors, including document timeline preparation, review cycles, and coordination of review meetingsFamiliarity with eCTD modulesKey Skills & CompetenciesStrong understanding of drug safety principles, clinical trial methodology, biostatistics, pharmacology, and oncologyFamiliarity with EU, US, and international regulatory guidelinesExcellent knowledge of company and sponsor-specific SOPsAbility to work independently, meet deadlines, and manage multiple projects simultaneouslyStrong teamwork, organization, and attention to detailExcellent communication and interpersonal skillsAdvanced proficiency in Microsoft Office SuiteWhats on OfferMy client fosters a friendly and supportive work culture that prioritizes people. They offer a competitive compensation and benefits package aligned with country-specific requirements.If you are an experienced medical writer looking to contribute to cutting-edge oncology research in a dynamic and collaborative environment, this role could be the perfect fit for you.