7 дней назад
Sr Labeling Project Coordinator (Pharmaceutical)
107 185 - 138 710$
Мэтч & Сопровод
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Описание вакансии
Текст:
TL;DR
Sr Labeling Project Coordinator (Pharmaceutical): Coordinating product labeling implementation across Regulatory Affairs, Legal, Package Engineering, Quality Assurance, Materials Management, and manufacturing sites with an accent on FDA compliance, cGMP requirements, and operational accuracy. Focus on leading complex cross-functional labeling projects, improving procedures and SOPs, and resolving implementation challenges in evolving environments.
Location: Santa Monica, California, United States; onsite attendance required 3 days per week
Salary: $107,185–$138,710 per year, plus potential annual bonus, stock-based long-term incentives, paid time off, and benefits.
Company
is a biopharmaceutical company developing CAR T-cell and T-cell receptor engineered therapies for cancer immunotherapy.
What you will do
- Serve as a labeling subject matter expert across Regulatory Affairs, Legal, Package Engineering, and Quality Assurance.
- Review and approve label design templates.
- Lead complex labeling projects and coordinate labeling implementation across Materials Management and manufacturing or packaging sites.
- Drive labeling processes to meet regulatory and business requirements and resolve cross-functional issues.
- Develop process improvements and author or revise systems, procedures, and SOPs.
- Support labeling accuracy, compliance, consistency, and operational excellence.
Requirements
- At least 5 years of relevant experience with a BS/BA degree, or at least 4 years with an MS degree.
- Pharmaceutical industry experience.
- Strong knowledge of FDA regulations, cGMP requirements, and regulatory guidance documents.
- Expertise in product labeling operations and implementation processes.
- Strong verbal communication, technical writing, interpersonal, and stakeholder-management skills.
- Proficiency with Microsoft Office and the ability to work effectively in ambiguous or evolving environments.
Nice to have
- Prior labeling experience.
Culture & Benefits
- Work focused on developing cancer therapies and personalized CAR T-cell treatments.
- Company-sponsored medical, dental, vision, and life insurance plans.
- Paid time off.
- Potential discretionary annual bonus and stock-based long-term incentives, depending on eligibility.
- Inclusive work environment focused on development, empowerment, and respect for individual differences.
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