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Internship Global Labeling Lead Jobs (NOW HIRING)

Eisai, Inc.

Senior Manager, Global Labeling

$129K - $169K/yr

The Senior Manager, Global Labeling facilitates and leads the development, review, approval, and ... Coordinate and lead cross-functional teams in the development and lifetime maintenance of the TPP ...

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Internship Global Labeling Lead information

What is the difference between Internship Global Labeling Lead vs Global Labeling Associate?

AspectInternship Global Labeling LeadGlobal Labeling Associate
Required CredentialsCurrently pursuing or recently completed a degree in life sciences or related fieldTypically entry-level, with some background in life sciences or related area
Work EnvironmentInternship setting within pharmaceutical or biotech companies, focusing on labeling projectsSupport role in labeling teams, assisting with documentation and compliance tasks
Employer & Industry UsageUsed in pharmaceutical companies during internship programs for future labeling professionalsCommonly employed as entry-level support staff in labeling departments

The Internship Global Labeling Lead is an internship position aimed at gaining experience in global labeling processes, often involving project support and learning. In contrast, the Global Labeling Associate is an entry-level role focused on assisting with labeling documentation and compliance tasks. The internship is temporary and educational, while the associate role is a foundational position within the labeling team, often leading to further career development.

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Senior Manager, Global Labeling

Eisai, Inc.

Remote

$129K - $169K/yr

Full-time

Posted 29 days ago

Job description

At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai's human health care (hhc) mission. We're a growing pharmaceutical company that is breaking through in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of many innovative medicines, notably the discovery of the world's most widely-used treatment for Alzheimer's disease. As we continue to expand, we are seeking highly-motivated individuals who want to work in a fast-paced environment and make a difference. If this is your profile, we want to hear from you.
The Senior Manager, Global Labeling facilitates and leads the development, review, approval, and maintenance of the Company Core Data Sheets (CCDS) for assigned products and the Country Product Information (CPI) and CPI components for assigned products either globally as a Global Labeling Lead or regional/local as a Regional Labeling Lead. The Senior Manager, Global Labeling represents the Global Regulatory Network (GRN) Global Labeling Group on project teams and acts as a Subject Matter Expert (SME) on local, regional and multi-country regulatory labeling requirements and participate in the sharing of intelligence. The Senior Manager, Global Labeling follows Global Labeling procedures and maintains relevant databases and document management systems for assigned products.
Essential Functions
  • Coordinate and lead cross-functional teams in the development and lifetime maintenance of the TPP, CCDS and Country Product Information (CPI) and CPI components for assigned products/projects. This includes QC, proofing, copy editing and formatting of documents, and coordinate review and approval of final submission. 30%
  • Provide tactical and strategic guidance to CPI development teams regarding regulatory requirements, content and design for TPP, CCDS, CPI and CPI components for assigned products on a global basis. 25%
  • Manage direct reports. 10%
  • Coordinate Content of Labeling/Drug Listing SPL generation and review to ensure compliance with US CPI regulations. 10%
  • Maintain labeling history documents and assist in responding to labeling-related queries from various functional areas. Maintain expertise regarding key labeling requirements worldwide and stay current with labeling guidelines and regulations on a global basis. 15%
  • Participate or lead special assignments related to GRN, GL or other cross-functional processes and/or activities. 10%

Requirements
  • Minimum BS degree or higher in life science.
  • 8+ years of experience in drug development environment, with minimum 3-5 years of regulatory experience within the pharmaceutical industry.
  • Experience in global and/or local regulatory labeling environments is preferred.
  • Demonstrate a solid working knowledge of drug development process, as well as FDA and EU labeling; knowledge of and experience with Asia and other markets labeling desirable.
  • Competent knowledge of and demonstrated ability to apply regulatory guidelines pertaining to product labeling and ICH guidelines.
  • Demonstrate strong project management, people management, problem solving, strategic thinking, negotiation, interpersonal and communication skills (both written and oral) attention to detail and ability to work under tight timelines.

Eisai Salary Transparency Language:
The annual base salary range for the Senior Manager, Global Labeling is from :$129,000-$169,300
Under current guidelines, this position is eligible to participate in : Eisai Inc. Annual Incentive Plan.
Final pay determinations will depend on various factors including but not limited to experience level, education, knowledge, and skills.
Employees are eligible to participate in Company employee benefit programs. For additional information on Company employee benefits programs, visit https://careers.eisai.com/us/en/compensation-and-benefits.
Certain other benefits may be available for this position, please discuss any questions with your recruiter.
Eisai is an equal opportunity employer and as such, is committed in policy and in practice to recruit, hire, train, and promote in all job qualifications without regard to race, color, religion, gender, age, national origin, citizenship status, marital status, sexual orientation, gender identity, disability or veteran status. Similarly, considering the need for reasonable accommodations, Eisai prohibits discrimination against persons because of disability, including disabled veterans.
Eisai Inc. participates in E-Verify. E-Verify is an Internet based system operated by the Department of Homeland Security in partnership with the Social Security Administration that allows participating employers to electronically verify the employment eligibility of all new hires in the United States. Please click on the following link for more information:
Right To Work
E-Verify Participation
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About Eisai

Sourced by ZipRecruiter

Eisai is a global pharmaceutical company (headquartered in Woodcliff Lake, NJ, US), renowned for its innovative research and development in neuroscience and oncology. The primary focus of the company is to provide therapeutic treatments and solutions for diseases like Alzheimer's, cancer, and other neurological disorders. Eisai was founded in Japan in 1941 and has since developed a strong presence across international markets. Eisai's core values center around their philosophy of 'human health care' (hhc), where they aim to make significant and positive contributions to patients and their families' healthcare worldwide.

Company size

1,001 - 5,000 Employees

Headquarters location

Nutley, NJ, US

Year founded

1995

Social media

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