Associate Site Manager at Johnson & Johnson overseeing clinical trial site activities and ensuring compliance. Requires 2 - 4 years of experience and a bachelor’s degree in life sciences.
About the role
- HUB Labeling Manager at Pfizer, responsible for regulatory labeling documentation for national markets. Collaborating on global tools and maintaining data integrity in labeling processes.
Responsibilities
- Responsible for preparation of LPDs, associated LLDs and PLDs for nationally registered products
- Update labeling documents on a timely basis according to internal SOPs and external regulatory requirements
- Act as a Subject Matter Expert (SME) on local, regional and multi-country regulatory labeling requirements
- Serve as an SME for the use and development of current and new global tools, technologies and processes to support label development
- Maintains system management for labeling activities including Global Document Management System (GDMS) and Pfizer approved labeling tracking system
- Monitors system data integrity and quality checks
- Produces labeling documents for submission to HAs such as track change versions, annotated labels, comparison tables
- Performs QC check of other colleagues’ work
- Identifies incremental improvements to labeling-related processes and systems
- Supports provision of other deliverables within the scope of ILG responsibilities e.g. readability testing
- Works on projects involving the use of current and new global tools, technology and processes to support label development
Requirements
- Life sciences, pharmacy graduate or equivalent; or equivalent relevant professional experience
- Fluency in English language important however multi-language skills are advantageous
- Experience working with structured data, such as in enterprise databases, MS Excel, MS SharePoint and/or MS Access
- Knowledge of key regulatory and labeling principles and local regulations
- ‘Hands on’ registration experience associated with development, maintenance and commercialization activities within Regulatory Affairs
- Demonstrated ability to develop strong and positive working relationships across multiple cultures and locations
- Demonstration of attention to detail and problem-solving skills
- Proven technical aptitude and ability to quickly learn new software
- Proven strength in logical, analytical and writing ability essential
Benefits
- Health insurance
- Retirement plans
- Paid time off
- Flexible work arrangements
- Professional development
- Disability inclusion
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
Area Manager role at Hemfrid in Gothenburg focusing on staff management and customer satisfaction. Responsible for achieving great experiences for both employees and customers daily.
Case Manager RN providing nursing care for home health patients in Washington's Olympic Peninsula. Supervising LPNs and HHAs while promoting continuity of care in various settings.
Demand Planning Manager leading AI - driven forecasting strategy at Wild Cosmetics. Own global demand signal leveraging machine learning and automation for operational excellence.
General Manager leading Virbac's Vietnam operations focusing on commercial strategies and market expansion. Overseeing P&L, regulatory compliance, and organizational development.
General Manager overseeing P&L, executing strategies in South Korea's animal health market. Focusing on commercial growth and operational excellence in companion and farm animal segments.
Disaster Workforce Engagement Manager guiding volunteer teams to deliver comfort in disaster situations at American Red Cross. Ensuring engagement and collaboration for effective disaster response operations.
Retail Store Manager overseeing daily operations and team management at AT&T. Ensuring exceptional service and achieving sales objectives in a retail environment.
Lead Project Control responsible for project delivery and customer satisfaction on large projects at GE Vernova. Manage project costs and schedules ensuring compliance with global standards.
RN administering skilled nursing for all ages in hospice care. Coordinating with interdisciplinary teams and complying with legal and company standards in patient care.