Position SummaryThe Principal Scientist, Global Labeling will report to the Director, Global Labeling and be responsible for the strategic global development, maintenance, and compliance of product labeling throughout a drug's lifecycle. This expert will work with other cross-functional teams and SMEs to ensure that all labeling for investigational and marketed drugs meet the regulatory requirements of global health authorities.
Essential Functions- Create and execute global labeling strategies from early clinical development through commercialization.
- Contribute to writing and maintaining key labeling documents, such as US Prescribing Information (USPI), and the EU Summary of Product Characteristics (SmPC).
- Ensure that all labeling content and artwork comply with international and local Health Authority regulations (e.g., FDA, EMA, MHRA etc.) and Good Manufacturing Practices (GMP). This includes monitoring for regulatory changes and implementing updates.
- Act as the primary labeling representative on various project teams, coordinating with departments like Clinical, Safety, Medical Affairs, Quality, Commercial, and Supply Chain.
- Manage the process of updating label content and artwork for packaging and supplies, coordinating with manufacturing and third-party vendors.
- Advise internal stakeholders on labeling content, processes, timelines, and potential risks, and present labeling strategies to senior leadership.
- Lead or support negotiations with Regulatory Agencies regarding the content of product labels.
- Create label technical specifications
- Creation of labeling related change controls
- Review and approve label proofs provided by internal and external labeling teams
- Assist with the preparation of responses to Health Authority comments and questions pertaining to labeling issues.
- Performs ad-hoc and cross-functional duties and/or projects assigned to support business needs and provide developmental opportunities.
Education & Experience- Bachelor's degree in life sciences or related field with 10+ years' experience working on clinical and commercial labels for varied types of drug products in a global setting required; or
- Master's degree in life sciences or related field with 8+ years' experience working on clinical and commercial labels for varied types of drug products in a global setting required.
- Familiar with organizing responses to Health Authority requests required
- Experience with Veeva Vault preferred
Knowledge, Skills, & Abilities- Expert in Global Health Authority Regulatory labeling requirements for both clinical and/or commercial stage products
- Proficient in Electronic Document Management Systems
- Ability to work with firm deadlines and adapt quickly to changing requirements and priorities
- Strong organizational skills, written and oral communication skills, and attention to detail.
- Keen awareness of cultural sensitivities
- Experience working in a complex and matrix environment
- Excellent interpersonal skills
Working Environment / Physical Environment- This position works on site in Summit, NJ.
- Regular work schedule is Monday-Friday, within standard business hours. Flexibility is available
- A Principal Scientist may need to sit for long periods of time and use various computer programs.
- This desk-based role involves the close study of scientific and regulatory documents.
- They will work closely with scientific colleagues throughout the day, often on a project team basis.
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.
$168,000 (entry-level qualifications) to $184,400 (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.
