Description
DESCRIPTIONThe Global Labeling Manager supports the Product Labeling Team in the management of labeling text through the processes and systems designed to support the optimal delivery and ultimate approval of product labeling. Responsible for managing the logistical aspects of the Labeling Sub-Team. Deliver "submission ready" product labels in applicable formats to support the submission and approval of products.
Responsibilities
- Perform project management role on Labeling Sub-Team (LST) by managing the logistical activities of the and delivering labeling documents within agreed timeframes.
- Work with Regulatory Strategists and cross-functional contributors to support timely submission, approval, and distribution of optimal product labeling in line with the strategies and objectives developed by the LST.
- For requested products, this position will work as a key contributor to the operational aspects of development, commercialization and distribution of labeling text in support of the goals outlined by the LST.
- Coordinate the review and approval of product labeling managed by the LST. This includes outlining the label history and documentation of team decisions.
- Receive and collate labeling text from LST members and put text into appropriate labels.
- Work collaboratively with members of the LST to resolve issues to execution of deliverables.
- Ensure content of labeling text is verified through its various renditions (such as Product Attribute Document, Annotated Package Insert, Core Data Sheet, US Package Insert, Summary of Product Characteristics, Package Leaflet, Patient Package Insert and Medication Guide).
- Manage core data sheet and approved labels in a label management database/corporate system to ensure that accurate and up to date labeling is available and accessible.
- Facilitate the labeling documents review and approval process.
- Notify appropriate downstream users of newly approved labels.
- Manage the process for delivery of product information through the Structured Product Labeling (SPL) process.
- Uses a range of effective communication styles and creates an inclusive environment with internal/external stakeholders to deliver goals and promote quality.
- Uses diplomacy and tact and can diffuse high-tension situations comfortably.
- Accepts and champions working in a Matrix model.
- Effectively implements procedures or makes decisions to deal with change.
- B.S./B.Sc in Pharmacy or Life Sciences preferred
- Advanced academic qualification/degree is highly desirable but not required; equivalent relevant professional experience will be considered
- Documentum based eDocument management systems (eg GDMS) experience
- Familiarity with pharmaceutical labeling activities
- Knowledge of XML based labeling systems and required submissions formats (eg SPL, PLR)
- Sound project management skills and time management
- Great attention to detail and ability to juggle many projects at once
- Clear written and verbal communication skills with sound interpersonal interactions
- Ability to negotiate and influence extremely helpful
- Previous experience related to labeling processes required
- Must be able to articulate transferable skills and demonstrate basic understanding of labeling operations processes
- Experience working in global/multi-national pharmaceutical environment and working in drug development
- Proven ability to work with minimal supervision
- Considers customers, including regulatory agencies, clinical, and safety in developing strategies and priorities for future business direction
- 4-7 years of Regulatory Documentation expertise
- Demonstrated knowledge of Labeling Processes, Regulatory codes/guidances, and technologies across ICH regions
- Communications skills
- Ability to communicate complex information and analyses to a variety of audiences in both verbal and written format
- Project Management skills
- Mastery of processes, tools, and techniques for planning and monitoring multiple complex projects to established deadlines
- Demonstrated ability to work with or lead a team in a Matrix structure
SKILLS
GDMS, Regulatory Documentation
Synectics offers competitive salaries and a full suite of benefits. EOE.