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Giant Spoon
New York, NY, United States
At Giant Spoon, the Strategy department is central to every project and client partnership. We are the provocateurs of the agency, helping to fuel big, creative ideas with unconventional thinking. We exist to illuminate new ways to see problems, and make ourselves essential through deep knowledge of consumers, technology, and culture. As a Senior
Job Source: Giant SpoonYoung & Rubicam
New York, NY, United States
Description Position at VMLY& R Who we are: At VML, we are a beacon of innovation and growth in an ever-evolving world. Our heritage is built upon a century of combined expertise, where creativity meets technology, and diverse perspectives ignite inspiration. With the merger of VMLY& R and Wunderman Thompson, we have forged a new path as a growth p
Job Source: Young & RubicamStoryful
New York, NY, United States
Job Description : Storyful, a News Corp company, is a global leader in social media news and intelligence, specializing in contextualization and verification. With a unique ability to gather and streamline data from the vast landscape of an increasingly complex media landscape, we believe in the power of social for a deeper understanding of global
Job Source: StoryfulAnalogFolk
New York, NY, United States
AnalogFolk is a global digitally native creative agency, independently owned since 2008. We have talented Folk across offices in London, Amsterdam, New York, Hong Kong, Shanghai, Singapore and Sydney. We deliver progressive solutions that change people's lives and fuel brand growth. We're proud to partner with some of the world's most respected a
Job Source: AnalogFolkVML
New York, NY, United States
Who We Are: At VML, we are a beacon of innovation and growth in an ever-evolving world. Our heritage is built upon a century of combined expertise, where creativity meets technology, and diverse perspectives ignite inspiration. With the merger of VMLY&R and Wunderman Thompson, we have forged a new path as a growth partner that is part creative age
Job Source: VMLDoSomething.org
New York, NY, United States
SENIOR STRATEGIST, DoSomething Strategic Reports To: Walker Post, Associate Director of Strategy Compensation: 68,000 - 75,000 Location: DoSomething.org is headquartered in New York City with a distributed workforce across the country. Preferably, candidates will be based in the New York City Metro area, but candidates in other locations within
Job Source: DoSomething.orgOnline Labels Group
Little Ferry, NJ, United States
_ **** _**** Overview We are in search of a Flexo Label Inspector/Rewinder for our Flexo Printing Manufacturing plant. No experience? Not to worry – we will train! Pay: $14.00-$15.00/hour to start. This position is a (4) 10-hour workday, Monday – Friday from 6:30am-5:00pm Benefits Medical Dental Vision Short-Term & Long Term Disability
Job Source: Online Labels GroupAgility Talent, LLC
, NY, United States
Our client is global software development firm and thought-leader passionate about social responsibility, revolutionizing the technology industry, consulting fortune 500 companies and hiring talented people! They are seeking a strategic and tactical Senior Marketing Strategist with a consulting firm and enterprise technology background to oversee a
Job Source: Agility Talent, LLCJersey City, NJ, United States
Job Title : Senior Labelling Strategist - Labelling (Remote)
Pay Rate: $50/hr - $58/hr
Duration : 39 W, 1 D
With a startup spirit and 115,000+ curious and courageous minds, we have the expertise to go deep with the world's biggest brands-and we have fun doing it! We dream in digital, dare, and reinvent the ways companies work to make an impact far bigger than just our bottom line. We are harnessing the power of technology and humanity to create meaningful transformation that moves us forward in our pursuit of a world that works better for people.
Now, we are calling upon the thinkers and doers, those with a natural curiosity and a hunger to keep learning, keep growing. People who thrive on fearlessly experimenting, seizing opportunities, and pushing boundaries to turn our vision into reality. And as you help us create a better world, we will help you build your own intellectual firepower.
Welcome to the relentless pursuit of better.
Inviting applications for the role of Senior Labelling Strategist - Labelling
In this role, you will be expected to work to deadlines in a fairly high-pressure business environment while being a good great teammate.
Responsibilities
Create, prepare, and revise CCDS, US and EU labeling for mature and life cycle products assigned to obtain company and/or agency approval.
Coordination of labeling review and approval throughout the E2E labeling process, which includes preparation of labeling components for submission to regulatory agencies, participation in labeling negotiations with agencies resulting in product approvals or labeling updates, and release of labeling for use throughout the company.
Strong knowledge and experience of Rx to OTC switch requirements.
Provides oversight for team and provides strategic guidance on complex labeling projects.
Must be able to work with all levels of associates and direct management within the Company (domestic/international) and demonstrate good communication, interpersonal and organizational skills.
Anticipates any hurdles in implementation and acts to minimize them.
Demonstrated knowledge and understanding of regulatory requirements for the CCDS, US and EU and local labeling implementation and the dynamics of Labeling Team purpose and objectives.
Knowledge of the principles and concepts of Labeling, including generics, authorized generics, private labels, device/combination products
Ability to read and interpret HA regulations and guidance, and underlying SOPs
Proven ability to lead regulatory strategy into labeling strategy.
Strong ability to lead meetings and propose labeling strategy, working well in cross-functional teams, and able to negotiate, resolve conflict and build consensus.
Lead a multidisciplinary labeling working group and provide labeling strategy proposal (Global Regulatory Affairs, Global Pharmacovigilance, Global Medical Affairs, Legal, Communication, preclinical and CMC...)
Proficient in presenting to senior management when required.
Highly detail oriented, strong analytical and organized skills, project management skills, self-starter, leadership skills, critical thinking required, strong ability to network and coordinate discussions across all levels of the company to reach resolution on labeling topics.
Must be able to construct a Company Response (MAH response) for health authority questions related to labeling.
Be an active member of Response Teams within procedures such as European Arbitration/referrals, or work-sharing, PRAC questions (signal detection...)
Extensive knowledge of EU regulations; be up to date with EU guidance's/regulations and inform management and team of changes.
Provide periodic training to the labeling team on EU regulations.
Qualifications we seek in you!
Bachelor's degree, in scientific discipline, or relevant/equivalent with relevant years of experience in Regulatory Affairs Labeling or equivalent in highly regulated environment. Published on 22 Dec 2023, 7:43 PM
Email Alert for Senior Labelling Strategist jobs in Jersey City, NJ, United States
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