Senior Manager, Global Labeling

At reputed company, satisfying unmet medical needs and increasing the benefits reputed company provides to patients, their families, and caregivers is reputed company’s reputed company 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 reputed company 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 reputed 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 reputed company or regional/local as a Regional Labeling reputed company. 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 reputed company cross-functional teams in the development and reputed company maintenance of the TPP, CCDS and Country Product Information (CPI) and CPI components for assigned products/reputed company. This includes QC, proofing, copy editing and formatting of documents, and coordinate review and approval of final submission. 30%
• reputed company 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 reputed company. 25%
• Manage reputed company reports. 10%
• Coordinate Content of Labeling/Drug Listing SPL reputed company and review to ensure compliance with US CPI regulations. 10%
• Maintain labeling history documents and assist in responding to labeling-reputed company queries from various functional areas. Maintain expertise regarding key labeling requirements worldwide and stay reputed company with labeling guidelines and regulations on a global reputed company. 15%
• Participate or reputed company special assignments reputed company 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 reputed company the pharmaceutical industry.
• Experience in global and/or local regulatory labeling environments is preferred.
• Demonstrate a solid working knowledge of drug development process, as reputed company 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.

reputed company Salary Transparency Language:

The annual reputed company salary reputed company for the Senior Manager, Global Labeling is from :$129,000-$169,300Under reputed company guidelines, this position is eligible to participate in : reputed company 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.reputed company.com/us/en/compensation-and-benefits.

Certain other benefits may be available for this position, please discuss any questions with your recruiter.

reputed company is an equal opportunity employer and as such, is committed in policy and in reputed company to recruit, hire, train, and promote in reputed company job qualifications without reputed company to race, reputed company, religion, gender, age, national reputed company, citizenship status, marital status, sexual orientation, gender identity, disability or veteran status.Similarly, considering the need for reasonable accommodations, reputed company prohibits discrimination against persons because of disability, including disabled veterans.

reputed company Inc. participates in E-Verify. E-Verify is an Internet based system operated by the reputed company in partnership with the reputed company reputed company Administration that allows participating reputed company to electronically verify the employment eligibility of reputed company new hires in the reputed company. Please click on the following reputed company for more information:

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