Regulatory Affairs Labeling Product Manager

1 month ago

Birch Run, Michigan, United States Johnson & Johnson Full time

Company Overview:
At Johnson & Johnson Innovative Medicine, we are dedicated to transforming healthcare through innovative solutions. Our commitment to health drives us to create a world where complex diseases are managed effectively, and treatments are personalized.

Position Summary:
The Associate Director, RA Labeling Product Leader will oversee the development and management of primary labeling documents, including the Company Core Data Sheet (CCDS), United States Package Insert (USPI), and associated patient labeling. This role is pivotal in ensuring compliance and high-quality standards in labeling documentation.

Key Responsibilities:
1. Lead the creation, revision, and maintenance of primary labeling documents.
2. Provide expert recommendations on labeling content, processes, and timelines.
3. Coordinate resolution of labeling issues impacting primary or derived labeling.
4. Ensure the production of compliant and high-quality labeling documents.
5. Collaborate with external partners as necessary.
6. Contribute to the global labeling strategy, demonstrating knowledge of competitive landscape and development plans.
7. Drive continuous improvement initiatives within the labeling process.

Qualifications:
Education:
A bachelor's degree in a scientific discipline is required; an advanced degree (MS, PhD, MD, or PharmD) is preferred.

Experience and Skills:
Required:
- Minimum of 8 years of relevant professional experience in the pharmaceutical industry, with at least 6 years focused on regulatory labeling content.
- Strong understanding of pharmaceutical drug development and worldwide regulatory guidelines.
- Proven ability to lead project teams in a matrix environment and work independently.
- Excellent verbal and written communication skills, with a proactive approach to problem-solving.

Preferred:
- Experience managing complex labeling projects.
- Track record of effectively prioritizing multiple projects.
- Ability to foster a collaborative and customer-focused work culture.

Compensation and Benefits:
The anticipated base pay range for this position is competitive and includes performance-based bonuses. Employees may participate in comprehensive benefits programs, including medical, dental, vision, and retirement plans.

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer, committed to diversity and inclusion in the workplace.

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