What are the responsibilities and job description for the Global Labeling Strategist position at Kelly Science, Engineering, Technology & Telecom?
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.
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,
#P1
As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.
Why Kelly® Science & Clinical?
Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the world’s most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals—it’s the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.
About Kelly
Work changes everything. And at Kelly, we’re obsessed with where it can take you. To us, it’s about more than simply accepting your next job opportunity. It’s the fuel that powers every next step of your life. It’s the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life—just ask the 300,000 people we employ each year.
Kelly is committed to providing equal employment opportunities to all qualified employees and applicants regardless of race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or any other legally protected status, and we take affirmative action to recruit, employ, and advance qualified individuals with disabilities and protected veterans in the workforce. Requests for accommodation related to our application process can be directed to the Kelly Human Resource Knowledge Center. Kelly complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.
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. Ideally ten years plus
- 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
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,
#P1
As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.
Why Kelly® Science & Clinical?
Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the world’s most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals—it’s the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.
About Kelly
Work changes everything. And at Kelly, we’re obsessed with where it can take you. To us, it’s about more than simply accepting your next job opportunity. It’s the fuel that powers every next step of your life. It’s the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life—just ask the 300,000 people we employ each year.
Kelly is committed to providing equal employment opportunities to all qualified employees and applicants regardless of race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or any other legally protected status, and we take affirmative action to recruit, employ, and advance qualified individuals with disabilities and protected veterans in the workforce. Requests for accommodation related to our application process can be directed to the Kelly Human Resource Knowledge Center. Kelly complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.
Salary : $65 - $80
