Senior Medical Writer

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 Responsibilities

As 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 amendments
• Clinical study protocols and protocol amendments
• Investigator’s brochures and 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:

• Minimum 5 years of experience in a CRO or pharmaceutical environment
• At least 3 years of experience in regulatory medical writing (oncology experience preferred)
• Lead writer experience on at least three of 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 with eCTD modules

Key Skills & Competencies

• Strong understanding of drug safety principles, clinical trial methodology, biostatistics, pharmacology, and oncology
• Familiarity with EU, US, and international regulatory guidelines
• Excellent knowledge of company and sponsor-specific SOPs
• 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 in Microsoft Office Suite

What’s on Offer

My 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.