Job Description

Senior Global Labeling Strategist

Kelly Science and Clinical is seeking a Senior Global Labeling Strategist for our client a leading Pharmaceutical company in Bridgewater, NJ. If you’re passionate about bringing the latest scientific discoveries to life and are ready to take the next step in your career, trust The Experts at Hiring Experts.

Schedule : remote – if remote worker must be open to traveling to Bridgewater, NJ once a month

Monday through Friday day shift

Length of assignment: 2 years

Pay $65-$80 an hour with flexibility

Depending on experience

The Global Labeling Strategist provides regulatory expertise and guidance for labeling strategy, to deliver high quality submission labeling and artwork for complex drug products, specific therapeutic/disease areas, and cross functional teams. Facilitate strategic development of labeling and labeling components, by leading a diverse cross-functional labeling sub team through discussion and decisions. Has a key role by sharing knowledge, providing labeling guidance, leading cross functional labeling teams and driving label development and execution.

• Lead preparation, review, and update of content for the development and maintenance of Target Product Profile (TPP), Company Core Data Sheet (CCDS), local labeling (USPI, SmPC, Canadian monographs) and labeling components.
• Evaluate and communicate risks associated with CCDS content updates and implementation strategies.
• Support global HA interaction strategy to discuss key labeling elements
• Demonstrate high-level understanding of labeling content requirements, regulations, and guidance in support of labeling strategies worldwide.
• Analyze and interpret new regulations and guidance, as well as monitor and determine impact on product labeling. Provides strategic advice on implementing new regulations.
• Assess competitor labeling - understand precedents & opportunities for Health Authority (HA) discussions
• Provide operational guidance and oversight to ensure all labeling documents are accurate, consistent, and compliant with all current regional regulatory regulation, guidance, templates, and requirements.
• Manage and maintain labeling documents in document management systems; Manage label review and approval.
• Partner with Regulatory Managers to ensure that all labeling is submission ready and available for publishing.
• During HA reviews, continuously assess dossier review comments for potential labeling impact, development of alternate proposals, and negotiation strategies.
• Lead, represent or contribute on product-specific Regulatory and Cross-Functional teams, as appropriate.
• Qualifications Required
• BSc or advanced scientific degree (MSc, PhD or PharmD) preferred.
• 5-10 years of relevant experience in pharmaceutical labeling/regulatory experience.
• Thorough understanding of scientific principals and regulatory systems, relevant to drug development
• Experience writing CCDS and USPI documents for new products.
• Preferred
• Knowledge and skills
• Solid understanding of pharmaceutical regulatory affairs, global labeling regulatory requirements and industry practice
• Exceptional understanding of medical concepts and terminology
• Strong written and oral communication skills, including presentation skills
• Solid ability to recognize and escalate issues

What happens next

Once you apply, you’ll proceed to the next steps if your skills and experience look like a good fit. But don’t worry—even if this position doesn’t work out, you’re still in our network. That means all of our recruiters will have access to your profile, expanding your opportunities even more.

Helping you discover what’s next in your career is what we’re all about,

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