Senior Medical Writer - Regulatory & Publications

Company Overview
ImmunityBio, 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 Summary

The Senior Medical Writer -Regulatory & Publications will be responsible for the preparation, development and support of high-quality regulatory and publications documents and writing activities , including but not limited to clinical study reports, clinical summaries and overviews, study protocols, Investigator's brochures, patient narratives, clinical development plans, clinical and real-world journal manuscripts,. The role will serve as subject matter expert within and across departments with minimal supervision.

Essential Functions

• Serve as a subject matter expert within department for assigned therapeutic/product areas; and as the medical writing lead on complex writing assignments within and across departmental team(s) on document strategies. Implement all activities related to the preparation of writing projects.
• Lead project team meetings and document review meetings, follow up on actions, and provide direction and solutions to cross-functional teams on expectations for document content.
• Write, edit, and finalize CSRs, clinical summaries and overviews, eCTD summaries, study protocols, IBs, ICFs, and other clinical study-related regulatory documents.
• Adhere to established regulatory standards, as well as company Standard Operating Procedures (SOPs), client standards, and company approved templates when completing medical writing projects, on-time and on-budget.
• Perform QC of clinical and nonclinical documents, and mentor less experienced medical writers on complex projects, as necessary
• Provide documents that are suitable for eCTD regulatory submissions by conducting appropriate formatting and hyperlinking per writing guidelines.
• Write, edit, and finalize clinical and nonclinical publications, manuscripts, journal abstracts, congress materials, educational/training materials, and other external-facing documents.
• Serve as peer reviewer providing review comments to give maximum clarity of meaning, accuracy relevance and to ensure that medical communications objectives are met. This includes reviewing statistical analysis plans and table/figure/listing specifications for appropriate content, and for grammar, format, and consistency.
• Ensure that all publication activities are of high scientific and medical quality and meet Good Publication Practices standards, align with SOPs and are documented appropriately.
• Ensure adherence to ICMJE/GPP and company policies and procedures for publications, staying abreast of any new advances and guideline updates and partnering with GMPC on ensuring training and adherence.
• Support the preparation and maintenance of a rolling 18-month strategic publication plans from a local perspective in coordination with the Medical Affairs team. Lead the process for review, approval, and submission/presentation of publications.
• Work collaboratively with other functional groups (eg, Regulatory Operations, Biometrics, Clinical Operations) to gather source data, and prepare and finalize regulatory documents. Identify and propose solutions to resolve issues and questions arising during the writing process, including resolution or escalation as appropriate.
• Perform other duties and projects as assigned.

Education & Experience

• A bachelor's degree in science-related fields with 7+ years of relevant industry experience in medical writing in the healthcare industry or academia required or in a related area such as quality, regulatory, publications, clinical research, or product support/R&D experience is required; or
• A master's degree in science-related fields with 5+ years of relevant industry experience in medical writing in the healthcare industry or academia required or in a related area such as quality, regulatory, publications, clinical research, or product support/R&D experience is required.
• Experience in NDA submissions and writing CSRs, IBs, clinical study protocols and other documents for regulatory submissions is required.
• Experience writing scientific medical publications such as journal manuscripts, abstracts, and congress materials required
• Strong scientific background in oncology, immunotherapy, or related field is required.

Knowledge, Skills, & Abilities

• Proficient knowledge of AMA writing guidelines.
• Excellent verbal and written communication skills in English.
• Extensive knowledge of FDA, EMA, and ICH guidelines.
• Deep understanding of the drug development process and prior experience in the biopharmaceutical industry.
• Ability to demonstrate familiarity with principles of clinical research and to interpret and present clinical data and other complex information.
• Excellent time- and project-management skills, attention to detail, and ability to balance multiple projects simultaneously.
• Ability to write effectively for diverse audiences, including scientists, physicians, payers, regulators, and patients.
• Understands budget specifications for assigned projects and working within the budgeted hours
• 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

• The position works either onsite in El Segundo, CA; Torrey Pines, CA; or remotely depending on the candidate's geographic location.
• Must possess mobility to work in a standard office setting and to use standard office equipment, including a computer.
• Regular work schedule is Monday - Friday, within standard business hours. Flexibility is available with manager approval
• 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.

National Market

$117,000 (entry-level qualifications) to $130,000 (highly experienced) annually

Premium Market

$131,400 (entry-level qualifications) to $146,000 (highly experienced) annually

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.