Principal Medical Publications Writer

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 Principal Medical Publications Writer will lead the preparation, development, and support of high-quality publications, documents, and writing activities, including but not limited to scientific literature reviews, citation documentation/management, abstracts, posters, manuscripts (real-world and clinical), plain-language summaries, letters to the editor, review articles for submission to peer-reviewed journals, conferences, and other medical education and medical communication pieces (print and digital) that support our Medical Affairs strategy. This role will serve as a subject matter expert, providing strategic guidance and oversight across departments with minimal supervision, ensuring that all publications meet regulatory standards, Good Publication Practices (GPP), and company policies.

Essential Functions

• Serve as a subject matter expert; and as the medical writing lead on complex writing assignments within and across departmental team(s) on document strategies.
• Lead project team meetings and document review meetings, follow up on actions, and provide direction and solutions to cross-functional teams on expectations for document content.
• Adhere to established regulatory standards, as well as company Standard Operating Procedures (SOPs), client standards, and company approved templates when completing medical writing projects, on-time and on-budget.
• Write, edit, and finalize clinical and nonclinical publications, manuscripts, journal abstracts, congress materials, educational/training materials, and other external-facing documents.
• Serve as peer reviewer providing review comments to give maximum clarity of meaning, accuracy, relevance and to ensure that medical communications objectives are met. This includes reviewing statistical analysis plans and table/figure/listing specifications for appropriate content, and for grammar, format, and consistency.
• Ensure that all publication activities are of high scientific and medical quality and meet Good Publication Practices standards, align with SOPs and are documented appropriately.
• Ensure adherence to ICMJE/GPP and company policies and procedures for publications, staying abreast of any new advances and guideline updates.
• Manage the development and execution of a “rolling” strategic publication plan for clinical and real-world evidence (RWE) studies, ensuring alignment with the medical and clinical development strategy and adhering to industry best practices (e.g., GPP, ICMJE, PRISMA, CONSORT, etc.).
• Lead the development, review, editorial, approval, and submission of manuscripts, abstracts, posters, and presentations across clinical trials, real-world evidence studies, and health economics outcomes research (HEOR).
• Collaborate with internal and external authors, key opinion leaders (KOLs), and research partners to develop scientific publications.
• Identify and propose solutions to resolve issues and questions arising during the writing process, including resolution or escalation as appropriate.
• Support necessary literature reviews and publication listings to pharmacovigilance department for use in periodic safety update reports (PSURs), and benefit-risk evaluations (PBRERs) as required.
• Perform ad-hoc and cross-functional projects as assigned to support business needs and provide developmental opportunities.

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