Principal Medical Publications Writer

ImmunityBio, Inc. • El Segundo, CA

82d • $138,600 - $152,400

About The Position

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.

Requirements

• Bachelor’s degree in science-related fields with 10+ years of relevant industry experience in medical writing in the healthcare industry or academia required; or Master’s degree in science-related fields with 8+ years of relevant industry experience; or Doctorates’ degree or equivalent in science-related fields with 6+ years of relevant industry experience.
• Strong expertise in clinical trial and RWE (Real World Evidence) publications, including phases I-IV, observational studies, registry data, and HEOR (Health Economics and Outcomes Research) required.
• Proven track record of leading publication strategies, delivering peer-reviewed publications, and congress presentations required.
• Experience in scientific writing, editing, and communicating complex data to diverse audiences.
• Strong scientific background in oncology, immunotherapy, or related field is required.

Nice To Haves

• CMPP (Certified Medical Publications Professional) or AMWA (American Medical Writers Association) Certification is preferred.

Responsibilities

• 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.
• 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.
• 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.

Benefits

• Medical, Dental and Vision Plan Options
• Health and Financial Wellness Programs
• Employer Assistance Program (EAP)
• Company Paid and Voluntary Life/AD&D, Short-Term and Long-Term Disability
• Healthcare and Dependent Care Flexible Spending Accounts
• 401(k) Retirement Plan with Company Match
• 529 Education Savings Program
• Voluntary Legal Services, Identity Theft Protection, Pet Insurance and Employee Discounts, Rewards and Perks
• Paid Time Off (PTO) includes: 11 Holidays
• Exempt Employees are eligible for Unlimited PTO
• Non-Exempt Employees are eligible for 10 Vacation Days, 56 Hours of Health Pay, 2 Personal Days and 1 Cultural Day

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Master's degree