Responsible for directing all aspects for Core Data Sheet development and maintenance for all global medical products and distribution of same to all affected LOC's ensuring CCDS's include all appropriate safety and efficacy information to present an accurate position for our medicines for optimal patient benefit and safety.
The incumbent will additionally provide operational oversight of all LOC level US labeling and will ensure awareness of evolving US regulatory initiatives that apply to labeling for all Takeda products marketed in the US. GL is responsible for aliging labeling content with regulatory requirements and interacting with global representatives to ensure consistency of CCDS development across all therapeutic areas
GL is further responsible for assessing the impact of statements in a regional or local label on the labels for the rest of the world where Takeda markets the product. ACCOUNTABILITIES:
Directs and manages Global Labeling and Labeling operations in the United States, including:
Qualifications EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
- Directs, establishes, implements, and maintains processes to generate, approve, and control Company Core Data Sheets for all Takeda Global Products. Work with LOC's on processes for implementation of labeling globally to assure compliance with government regulations and Takeda quality standards and to ensure commercial product integrity.
- Oversees the resource allocation for all products. Manages the work flow and production of the creation, approval, release, control, maintenance, and archival of all Labeling components as appropriate.
- Develops and implements new methods to improve the efficiency of the Labeling Department.
- Responsible for support of the teams in development and established products in the creation of the dCCDS (the development CCDS).
- Establishes and manages relationships with Takeda business partners and Affiliates to ensure label control, efficient label creation and continuous improvement of programs to meet business needs and regulatory requirements.
- Drafts and negotiates Labeling Service Agreements with business partners and Affiliates
- Identifies, evaluates and implements technology in support of label operations and improve efficiencies.
- Recommends courses of action on management and Human Resources matters in the department, including salary administration, promotions, transfers, hiring, terminations, training and development of managerial and professional staff, performance appraisals, position descriptions, and employee counseling.
- Guides and directs the Labeling staff in the achievement of their professional goals through training and regular mentoring.
- BS/BA degree or advanced scientific or related degree. Scientific degree preferred.
- 12+ years of experience in a regulated environment with a minimum of 6 years working in the pharmaceutical industry. Prior Labeling experience preferred.
- Previous management experience.
- Significant working knowledge of FDA regulations related to New Drug Applications, Good Manufacturing Practices, and Product Labeling.
- Understanding of scientific principles and regulatory/quality systems relevant to drug development.
- Demonstrated problem-solving ability with demonstrated generation of alternative solutions prior to elevation of issues to management.
- Excellent oral and written communication skills
- Demonstrated analytical and problem solving skills
- Demonstrated attention to detail
- Ability to both direct and work in a team environment
- Willingness to travel to various meetings, including overnight trips. Some international travel may be required.
- May require up to 20 % travel.
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