Eisai
Senior Manager, Global Labeling
United States, Remote · Senior
Sponsorship not specified$129k-$169kDetected 7 days ago
Project ManagementNegotiationFDA RegulatoryResearchLeadershipCommunicationProblem Solving
About the role
- 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.
- If this is your profile, we want to hear from you.
Responsibilities
- 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.
- 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%
- 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.
- 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.
- 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.
Nice to have
- Experience in global and/or local regulatory labeling environments is preferred.
Skills
- 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 Inc. participates in E-Verify.
Compensation
- The annual base salary range for the Senior Manager, Global Labeling is from:$129,000-$169,300
Visa & Work Authorization
- re, 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 statu
This listing is sourced directly from Eisai's careers page and normalized into a canonical job model.