ImmunityBio
Medical Writer
ImmunityBio, El Segundo, California, United States, 90245
Company OverviewImmunityBio, Inc. (NASDAQ: IBRX) is a commercial-stage biotechnology company developing cell and immunotherapy products that are designed to help strengthen each patient's natural immune system, potentially enabling it to outsmart the disease and eliminate cancerous or infected cells. We envision a day when we no longer fear cancer, but can conquer it, thanks to the biological wonder that is the human immune system. Our scientists are working to develop novel therapies that harness that inherent power by amplifying both branches of the immune system, attacking cancerous or infected cells today while building immunological memory for tomorrow. The goal: to reprogram the patient's immune system and treat the host rather than just the disease.
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 a publicly traded biopharmaceutical company with headquarters in Southern California.* Work with a collaborative team with the ability to work across different areas of the company.* Ability to join a growing company with professional development opportunities.Position SummaryThe 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 FunctionsWrite, 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 documentsProvide 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 & ExperienceA 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, & AbilitiesProficient knowledge of AMA writing guidelinesExcellent verbal and written communication skills in EnglishKnowledge 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 EnvironmentThis position works on site 5 days a weekMust 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.
At ImmunityBio, we are an equal opportunity employer dedicated to diversity in the workplace. Our policy is to provide equal employment opportunities to all qualified persons without regard to race, gender, color, disability, national origin, age, religion, union affiliation, sexual orientation, veteran status, citizenship, gender identity and/or expression, or other status protected by law.
ImmunityBio is a mandatory vaccination employer for COVID-19 and its variants. The Company requires that its employees be fully vaccinated as of their start date. If you require a medical or religious accommodation we will engage in the interactive process with you. Proof of vaccination will be required prior to start. If we make you an offer and you are not yet vaccinated, we will accommodate a delay in start date. ImmunityBio may also mandate that its employees receive vaccine boosters, and all accommodation laws will be followed.
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 a publicly traded biopharmaceutical company with headquarters in Southern California.* Work with a collaborative team with the ability to work across different areas of the company.* Ability to join a growing company with professional development opportunities.Position SummaryThe 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 FunctionsWrite, 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 documentsProvide 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 & ExperienceA 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, & AbilitiesProficient knowledge of AMA writing guidelinesExcellent verbal and written communication skills in EnglishKnowledge 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 EnvironmentThis position works on site 5 days a weekMust 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.
At ImmunityBio, we are an equal opportunity employer dedicated to diversity in the workplace. Our policy is to provide equal employment opportunities to all qualified persons without regard to race, gender, color, disability, national origin, age, religion, union affiliation, sexual orientation, veteran status, citizenship, gender identity and/or expression, or other status protected by law.
ImmunityBio is a mandatory vaccination employer for COVID-19 and its variants. The Company requires that its employees be fully vaccinated as of their start date. If you require a medical or religious accommodation we will engage in the interactive process with you. Proof of vaccination will be required prior to start. If we make you an offer and you are not yet vaccinated, we will accommodate a delay in start date. ImmunityBio may also mandate that its employees receive vaccine boosters, and all accommodation laws will be followed.