Medical Writer

Job not on LinkedIn

November 19

🏄 California – Remote

Although this job is listed in California, this company may be open to hiring remote in other states.

💵 $100k - $110k / year

⏰ Full Time

🟢 Junior

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ImmunityBio, Inc.

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Biotechnology • Healthcare Insurance • Pharmaceuticals

ImmunityBio, Inc. is a biotechnology company focused on developing innovative immunotherapies to enhance the immune system's ability to fight cancer and infectious diseases. By harnessing the power of the body’s immune response, ImmunityBio aims to provide breakthrough treatments that can improve patient outcomes and longevity in challenging diseases.

501 - 1000 employees

🧬 Biotechnology

⚕️ Healthcare Insurance

💊 Pharmaceuticals

📋 Description

• 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 document review meetings and discussions. • 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. • Participate in project team meetings. • Performs other duties as assigned.

🎯 Requirements

• A bachelor’s degree in science-related fields with 1+ years of experience is required; • A master’s degree in science-related fields with some experience is required. • 1+ year of medical writing experience preferred. • Experience in NDA submissions and writing CSRs, IBs, clinical study protocols and other documents for regulatory submissions required. • Strong scientific background in oncology, immunotherapy, or related field required. • Proficient knowledge of AMA writing guidelines. • Excellent verbal and written communication skills in English. • Knowledge of FDA, EMA, and ICH guidelines. • Deep understanding of the drug development process and prior experience in the biopharmaceutical industry. • Excellent time- and project-management skills, attention to detail, and ability to balance multiple projects simultaneously. • Strong critical and logical thinking with ability to analyze problems, identify alternative solutions, and implement recommendations for resolution. • Ability to work collaboratively in a dynamic environment. • 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