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 collaborativeSenior Medical Writerwith5+ years of experienceto join their team. This role is ideal for a self-starter who wants to be involved in the full regulatory medical writing lifecycle.
Key Responsibilities
As a Senior Medical Writer, you will be responsible for preparing a range of regulatory and clinical documents, including:
- InitialInvestigational New Drug (IND) applicationsand amendments
- Clinical study protocolsand protocol amendments
- Investigator’s brochuresand updates
- Interim and final clinical study reports
- IND annual reports
- Development Safety Update Reports (DSURs)
- Patient informed consent forms
- Providing guidance and support to internal teams on manuals, training guidelines, and related documents
- Acting as a mentor and resource for junior medical writers
Experience:
- Minimum5 years of experiencein a CRO or pharmaceutical environment
- At least3 years of experiencein regulatory medical writing (oncology experience preferred)
- Lead writer experience on at leastthreeof the following:
- Clinical Study Protocols
- Clinical Study Reports
- Investigator’s Brochures
- Development Safety Update Reports
- IND Applications
- Informed Consent Forms
- Experience working directly with clients or sponsors, including document timeline preparation, review cycles, and coordination of review meetings
- Familiarity witheCTD modules
Key Skills & Competencies
- Strong understanding ofdrug safety principles, clinical trial methodology, biostatistics, pharmacology, and oncology
- Familiarity withEU, US, and international regulatory guidelines
- Excellent knowledge of company and sponsor-specificSOPs
- Ability to work independently, meet deadlines, and manage multiple projects simultaneously
- Strong teamwork, organization, and attention to detail
- Excellent communication and interpersonal skills
- Advanced proficiency inMicrosoft Office Suite
What’s on Offer
My client fosters afriendly and supportive work culturethat prioritizes people. They offer acompetitive compensation and benefits packagealigned 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.
