Medical Writer
2 weeks ago
Position Summary
The 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 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
Write, edit, and finalize CSRs, clinical summaries and overviews, eCTD summaries, study protocols, IBs, ICFs, and other clinical study-related regulatory documents. As needed, 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.Education & Experience
A minimum Bachelor’s degree in science required. A Master’s or PhD degree preferred. Experience in NDA submissions and writing CSRs, IBs, clinical study protocols and other documents for regulatory submissions. Strong scientific background in oncology, immunotherapy, or related fieldKnowledge, Skills, & Abilities
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 templatesWorking Environment / Physical Environment
This position works on site 5 days a week Must possess mobility to work in a standard office setting and to use standard office equipment, including a computer. Lift and carry materials weighing up to 20 pounds.This position is eligible for a discretionary bonus and equity award. The annual base pay range for this position is below. The specific rate will depend on the successful candidate’s qualifications, prior experience as well as geographic location.
$90,000 (entry-level qualifications) to $116,000 (highly experienced)
The application window is anticipated to close on 60 days from when it is posted or sooner if the position is filled or closed.
ImmunityBio employees are as valuable as the people we serve. We have built a resource of robust benefit offerings to best support the total wellbeing of our team members and their families. Our competitive total rewards benefits package, for eligible employees, include: 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.
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