Associate Director, Medical Writing

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 Associate Director, Medical Writing is responsibility for leading the day-to-day activities of the medical writing team and assisting the Director, Medical Writing with strategic planning of medical writing activities, allocating resources, and ensuring the quality and consistency of deliverables. The role will assist with implementing standardized policies for drafting and finalizing regulatory documents and serving as a subject matter expert within the department and cross functionally. The role is 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

• Serve as medical writing lead and subject matter expert on multiple concurrent complex writing assignments. Work closely with in-function and cross-functional team(s) on document strategies.
• Lead the day-to-day activities of the medical writers to include training new team members, coaching employees and monitoring performance. Participate in hiring new team members as needed.
• Contribute to the development of medical writing strategies and provide input on regulatory submission strategies.
• Draft, edit, and finalize development of regulatory documents (protocols, IBs, CSRs) for FDA submission.
• Write, edit, and finalize clinical and non-clinical publications, congress materials, educational/training materials, and other external-facing documents.
• Develop, implement and adhere to the Scientific Communications Standard Operating Procedures (SOPs) to ensure that publication activities are aligned with strategic initiatives and industry best practices.
• Partner cross-functionally on teams to develop and implement regulatory documents and strategic publication plans for regulatory submissions and scientific manuscripts.
• Identify, propose and implement solutions to resolve issues and questions arising during the writing process, including resolution or escalation as needed.
• Guide scientific content development for regulatory documents and scientific publications.
• Assist with the development and implementation of strategic publication plans for creating, coordinating, and tracking scientific publication materials (manuscripts, abstracts, posters, and slide presentations) as needed.
• Lead project team meetings and document review meetings.
• Provide direction and solutions to cross-functional teams on expectations for document content.
• Ensure quality, consistency, alignment, and compliance of regulatory documents and publications inclusive of performing quality checks of clinical and nonclinical documents.
• Ensure documents are suitable for eCTD regulatory submissions by conducting appropriate formatting and hyperlinking per writing guidelines.
• Perform ad-hoc and cross-functional projects as assigned to support business needs and provide developmental opportunities.

Education & Experience

• Bachelor's Degree in a science-related field with 10+ years of relevant industry experience in medical writing in the healthcare industry or academia required; or
• Masters' Degree in a science-related field with 8+ years of relevant industry experience in medical writing in the healthcare industry or academia required; or
• PhD in a science-related field with 6+ years of relevant industry experience in medical writing in the healthcare industry or academia required
• Demonstrated experience in guiding medical writing efforts for clinical development of one or more investigational products required.
• Demonstrated expertise in writing and editing regulatory documents (clinical study protocols, IBs, CSRs) is required
• Experience in NDA/BLA submissions and writing CSRs, IBs, clinical study protocols and other documents for global regulatory submissions is required.
• Experience and strong scientific background in oncology, immunotherapy, or related field is required
• Prior experience in the biopharmaceutical industry preferred

Knowledge, Skills, & Abilities

• Understanding good publication practices and guidelines, ie, ICMJE, GPP3, etc.
• Proficient knowledge of AMA style guidelines.
• Extensive knowledge of FDA, EMA, and ICH guidelines.
• Deep understanding and knowledge of the drug development process
• Ability to manage multiple projects and priorities simultaneously, meet deadlines, and adjust to shifting priorities in a fast-paced environment.
• Established proficiency with principles of clinical research and expertise in the interpretation and presentation of clinical data and other complex information.
• Ability to work cross-functionally and lead teams.
• Excellent written and verbal communication skills, with the ability to articulate complex technical information clearly and compellingly.
• Disciplinary expertise in oncology, immunology, and/or infectious disease.
• Strong critical and logical thinking skills with the ability to analyze problems, identify alternative solutions, and implement recommendations for resolution.
• Ability to work independently and collaboratively: prioritize tasks, problem solve, and complete high-quality documents under aggressive timelines
• 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 onsite or remote based on the employee's geographic location.
• Regular work schedule is Monday - Friday, within standard business hours. Flexibility is available with manager approval.
• 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.

National Market (all markets unless identified as Premium)

$130,000 (entry-level qualifications) to $143,000 (highly experienced) annually

Premium Market (Premium markets include Los Angeles, San Diego, San Francisco, New York City, Chicago, & Boston)

$138,000 (entry-level qualifications) to $150,000 (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.