Job Description

Join to apply for the Senior Medical Writer role at ImmunityBio, Inc. 6 days ago Be among the first 25 applicants Join to apply for the Senior Medical Writer role at ImmunityBio, Inc. Get AI-powered advice on this job and more exclusive features. Company Overview ImmunityBio, Inc. (NASDAQ: IBRX) is a commercial-stage biotechnology company developing cell and immunotherapy products that are designed to help strengthen each patient’s natural immune system, potentially enabling it to outsmart the disease and eliminate cancerous or infected cells. We envision a day when we no longer fear cancer, but can conquer it, thanks to the biological wonder that is the human immune system. Our scientists are working to develop novel therapies that harness that inherent power by amplifying both branches of the immune system, attacking cancerous or infected cells today while building immunological memory for tomorrow. The goal: to reprogram the patient’s immune system and treat the host rather than just the disease. Position Summary The Senior Medical Writer will be responsible for preparing high-quality regulatory documents, including clinical study reports, clinical summaries and overviews, study protocols, Investigator’s brochures, and informed consent forms. The role also involves complex writing assignments and serving as a subject matter expert. Additionally, the Senior Medical Writer may plan, manage, and prepare internal and external communications of scientific and clinical data, such as abstracts, posters, presentations, manuscripts, congress materials, and educational/training materials. Essential Functions Lead complex medical writing projects and collaborate with cross-functional teams on document strategies. Serve as a subject matter expert in assigned therapeutic areas. Mentor less experienced medical writers. Resolve issues during the writing process and escalate as needed. Draft, edit, and finalize regulatory documents like CSRs, clinical summaries, protocols, IBs, and ICFs. Prepare external documents such as publications, congress materials, and training content. Write for diverse audiences including scientists, physicians, regulators, and patients. Collaborate with other departments to gather data and finalize documents. Lead project meetings and document reviews. Ensure documents meet formatting and hyperlinking standards for eCTD submissions. Perform quality control on documents. Education & Experience Bachelor’s degree in a science-related field with 4+ years of relevant experience, or Master’s degree with 2+ years of relevant experience. Experience with NDA submissions, CSRs, IBs, and clinical protocols is required. Strong background in oncology, immunotherapy, or related fields. Knowledge, Skills, & Abilities Proficient in AMA guidelines and familiar with FDA, EMA, ICH regulations. Excellent communication skills in English. Deep understanding of drug development and clinical research. Strong project management and attention to detail. Proficiency in MS Office, Adobe Acrobat, EndNote, and eCTD templates. Working Environment Onsite position in a standard office setting. Standard work hours, Monday to Friday, with flexibility. Ability to lift up to 20 pounds. The salary range is $117,000 to $130,000 annually, depending on experience and location. ImmunityBio offers a comprehensive benefits package and is an equal opportunity employer committed to diversity. #J-18808-Ljbffr ImmunityBio, Inc.

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