Clinical Label Manager
The Clinical Label Manager will lead the process for clinical content development and maintenance for clinical labeling and labeling components. They will be responsible for the oversight and management of the global label creation activities in support clinical development programs. This position will oversee the creation, maintenance, storage, translations of the clinical label process through the management of the internal process and oversight of the vendors. The ideal candidate will be results-oriented with concerns for quality and collaboration. They will demonstrate a high-level understanding of labeling content requirements, regulations and guidance in support of labeling strategies. May be assigned additional responsibilities as deemed necessary.
This individual will be responsible for developing business processes to support the creation and maintenance of labeling activities for clinical development while maintaining compliance to all applicable regulations and requirements
- Responsible for a robust and compliant clinical label management system to ensure all labeling materials follow relevant laws and regulations, including:
- Text delivery
- Country designation
- Label design
- Translation service and certification
- Revision history
- Archiving and retrieval
- Proof approval
- Vendor management
- Analyzes and interprets new regulations and guidance as well as monitors and determines the impact of the regulatory environment and applicable regulatory decisions affecting clinical labeling in conjunction with regulatory.
- Plan and lead cross-functional labeling team meetings to discuss and develop label content for new molecular entities (NMEs), and developmental products.
- Moderate and liaise with subject matter experts based on functional area(s) to resolve labeling issues or meet regulatory/health authority timelines.
- Follows and formulates improvements to labeling policies, processes, quality, and system tools.
- Provide creative and innovative ideas to move the Global Supply Chain and Regulatory department to address current and future challenges.
- Strong knowledge of cGMP's, cGDP, cGCP, 21CFR and ICH
- 5-7 years of relevant experience in pharmaceutical regulatory/labeling environment.
- Demonstrated ability to work with people in a global, dynamic environment to deliver value-added results.
Knowledge, Skills And Other Experience
- Solid understanding of global labeling regulatory requirements and industry practice
- Broad knowledge of clinical, CMC preclinical and clinical pharmacology
- Excellent understanding of medical concepts and terminology
- Solid understanding of the structure and function of product labeling
- Fundamental understanding of the pharmaceutical industry drug development process
- Strong written and oral communication skills
- Good computer skills including experience with MS Office: Word, Excel, PowerPoint, and Outlook and Adobe products
- Action oriented, customer focused, ability to manage workloads, set priorities, and have demonstrated the ability to build effective teams.
- Must be able to deal with ambiguity.
- Ability to generate problem solving innovative solutions and motivate others to be innovative.
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.
Required Education & Experience
- BS in life sciences, scientific, or engineering field or equivalent experience
Position Type/Expected Hours of Work
This is a full-time position. Days and hours of work are Monday through Friday, 8:30 a.m. to 5 p.m. This position regularly requires long hours and may require weekend work.
This job operates in a professional office and/or remote-work environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines.