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.
- Facilitate and Lead the development, review, approval, and maintenance of the Company Core Data Sheets (CCDS) for assigned products.
- Facilitate and Lead the development, review, approval, and maintenance of 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.
- Represents the Global Regulatory Network (GRN) Global Labeling Group on project teams.
- Act as a Subject Matter Expert (SME) on local, regional and multi-country regulatory labeling requirements and participate in the sharing of intelligence.
- Follows Global Labeling procedures and maintains relevant databases and document management systems for assigned products.
- May develop and implement policies and operational targets that have a direct impact on GL group or operational outcome, as assigned. Activities may include policy changes and/or recommendations.
- May lead a process improvement work stream, as assigned.
- May have responsibility for management of employees within the department.
- Technical expert with sufficient expertise and experience to be considered for sensitive and/or complex assignments.
- 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%
- 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 requires all new hires to be fully vaccinated against COVID-19 and provide valid proof of vaccination as of their start date, to the extent permitted under applicable law. This requirement is a condition of employment at Eisai, and it applies regardless of whether the position is located at an Eisai site, field based or is fully remote. If you are unable to receive the vaccine for qualifying medical reasons (including pregnancy-related), or religious reasons (sincerely held religious beliefs), you will have an opportunity to request a reasonable accommodation.
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:
Employment/Position Type:Full Time
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