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Medical Writer
4 months ago
ImmunityBio, Inc. is a late-stage immunotherapy company developing a broad pipeline of next-generation therapies that drive immunogenic mechanisms for defeating cancer and infectious disease. The company’s immunotherapy platform is designed to activate both the innate (natural killer cell and macrophage) and adaptive (T cell) immune systems to create long-term “immunological memory.” The U.S. Food and Drug Administration (FDA) has accepted for review ImmunityBio’s resubmission of its Biologics License Application (BLA) for N-803, a first-in-class IL-15 superagonist, plus Bacillus Calmette-Guérin (BCG) for the treatment of BCG-unresponsive non-muscle-invasive bladder cancer carcinoma in situ (CIS) with or without Ta or T1 disease, and has set a user fee goal date (PDUFA date) of April 23, 2024.
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 an early-stage public biopharmaceutical company with a headquarters in Southern California.
- Work with a collaborative team with the ability to work across different areas at the company.
- Ability to join a growing company with development opportunities.
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 field
Knowledge, 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 templates
Working 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.
$90,000 (entry-level qualifications) to $116,000 (highly experienced)
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 Progr
