Senior Medical Writer

Benefits

Additional Information

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. Why ImmunityBio? - ImmunityBio is developing cutting-edge technology with the goal to transform the lives of patients with cancer and develop next-generation therapies and vaccines that complement, harness and amplify the immune system to defeat cancers and infectious diseases. - Opportunity to join a publicly traded biopharmaceutical company with headquarters in Southern California. - Work with a collaborative team with the ability to work across different areas of the company. - Ability to join a growing company with professional development opportunities. Position Summary The Senior Medical Writer will be responsible for the preparation of high-quality regulatory documents, including clinical study reports, clinical summaries and overviews, study protocols, Investigator's brochures, and informed consent forms. The Senior Medical Writer will also be responsible for more complex writing assignments and will serve as subject matter expert within the department. The Senior Medical Writer may also be responsible for planning, managing, and preparing internal and external communications of key scientific and clinical data, including abstracts, poster and oral presentations, manuscripts, congress materials, and educational/training materials. Essential Functions Serve as medical writing lead on more complex writing assignments. Work closely with in-function and cross-functional team(s) on document strategies. Implement all activities related to the preparation of writing projects. Serve as a subject matter expert within department for assigned therapeutic/product areas. Mentor less experienced medical writers on complex projects, as necessary. Identify and propose solutions to resolve issues and questions arising during the writing process, including resolution or escalation as appropriate. Write, edit, and finalize CSRs, clinical summaries and overviews, eCTD summaries, study protocols, IBs, ICFs, and other clinical study-related regulatory documents. Write, edit, and finalize clinical and non-clinical publications, congress materials, educational/training materials, and other external-facing documents. Write effectively for diverse audiences, including scientists, physicians, payers, regulators, and patients. Work collaboratively with other functional groups (eg, Regulatory Operations, Biometrics, Clinical Operations) to gather source data, and prepare and finalize regulatory documents. Lead project team meetings and document review meetings. Provide direction and solutions to cross-functional teams on expectations for document content. Perform QC of clinical and nonclinical documents. Provide documents that are suitable for eCTD regulatory submissions by conducting appropriate formatting and hyperlinking per writing guidelines. Perform other duties as assigned. Education & Experience A bachelor's degree in science-related fields with 4+ years of relevant industry experience in medical writing in the healthcare industry or academia required or in a related area such as quality, regulatory, publications, clinical research, or product support/R&D experience is required; Or A master's degree in science-related fields with 2+ years of relevant industry experience in medical writing in the healthcare industry or academia required or in a related area such as quality, regulatory, publications, clinical research, or product support/R&D experience is required. Experience in NDA submissions and writing CSRs, IBs, clinical study protocols and other documents for regulatory submissions is required. Strong scientific background in oncology, immunotherapy, or related field is required. Knowledge, Skills, & Abilities Proficient knowledge of AMA writing guidelines. Excellent verbal and written communication skills in English. Extensive knowledge of FDA, EMA, and ICH guidelines. Deep understanding of the drug development process and prior experience in the biopharmaceutical industry. Ability to demonstrate familiarity with principles of clinical research and to interpret and present clinical data and other complex information. Excellent time- and project-management skills, attention to detail, and ability to balance multiple projects simultaneously. Strong critical a