ImmunityBio, Inc.

Compensation

Full Description

Description: • Lead day-to-day activities of medical writing team; train, coach, and monitor performance. • Assist Director, Medical Writing with strategic planning, resource allocation, and standardizing policies for regulatory document drafting and finalization. • Plan, manage, and prepare internal and external communications of scientific and clinical data including abstracts, posters, presentations, manuscripts, congress materials, and educational/training materials. • Serve as medical writing lead and subject matter expert on multiple concurrent complex writing assignments. • Work closely with in-function and cross-functional teams on document strategies and regulatory submission strategies. • Draft, edit, and finalize regulatory documents (protocols, IBs, CSRs) for FDA submission and global regulatory submissions. • Develop and implement Scientific Communications SOPs and ensure publication activities align with strategic initiatives and industry best practices. • Lead project team and document review meetings; provide direction and solutions to cross-functional teams on document content and expectations. • Ensure quality, consistency, alignment, and compliance of regulatory documents and publications, including eCTD formatting and hyperlinking. • Perform ad-hoc and cross-functional projects to support business needs and provide developmental opportunities. Requirements: Bachelor’s Degree in a science-related field with 10+ years of relevant industry experience in medical writing in the healthcare industry or academia required; or Masters’ Degree in a science-related field with 8+ years of relevant industry experience in medical writing in the healthcare industry or academia required; or PhD in a science-related field with 6+ years of relevant industry experience in medical writing in the healthcare industry or academia required • Demonstrated experience in guiding medical writing efforts for clinical development of one or more investigational products required. • Demonstrated expertise in writing and editing regulatory documents (clinical study protocols, IBs, CSRs) is required • Experience in NDA/BLA submissions and writing CSRs, IBs, clinical study protocols and other documents for global regulatory submissions is required. • Experience and strong scientific background in oncology, immunotherapy, or related field is required. • Prior experience in the biopharmaceutical industry preferred • Understanding good publication practices and guidelines, ie, ICMJE, GPP3, etc. • Proficient knowledge of AMA style guidelines. • Extensive knowledge of FDA, EMA, and ICH guidelines. • Deep understanding and knowledge of the drug development process • Ability to manage multiple projects and priorities simultaneously, meet deadlines, and adjust to shifting priorities in a fast-paced environment. • Established proficiency with principles of clinical research and expertise in the interpretation and presentation of clinical data and other complex information. • Ability to work cross-functionally and lead teams. • Excellent written and verbal communication skills, with the ability to articulate complex technical information clearly and compellingly. • Disciplinary expertise in oncology, immunology, and/or infectious disease. • Strong critical and logical thinking skills with the ability to analyze problems, identify alternative solutions, and implement recommendations for resolution. • Ability to work independently and collaboratively: prioritize tasks, problem solve, and complete high-quality documents under aggressive timelines • Highly proficient in MS Project, MS Office (Word, Excel, PowerPoint, Outlook), Adobe Acrobat, EndNote, and eCTD authoring templates. 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 • We are committed to providing you with the tools and resources you need to optimize your Health and Wellness. At ImmunityBio, we are an equal opportunity employer dedicated to diversity in the workplace.