Our client in the biopharmaceutical industry is currently seeking a Manager of Global Labeling in King of Prussia PA. FULLY REMOTE WORK IS OPEN FOR CONSIDERATION
The Manager of global labeling Associate (GLA) focuses on end-to-end non-US/Central EU (Most of World) labeling development and implementation. This position provides innovation and technical expertise for the creation, maintenance and implementation of labeling to meet country-specific regulatory requirements and effectively manages labeling operations globally. Additionally, this role participates in a 'follow the sun' model for the review and escalation of differences in local labeling as they relate to the company's core position. Key partner to GRA Regions, GRA GPS TA's, Global Labeling Experts, GRA Regulatory CMC and End-to-End Supply groups. This position reports to Director, Global Labeling Operations.
Main Responsibilities and Accountabilities:
* Supports cross-functional, end-to-end non-US/Central EU global labeling processes across the company utilizing cross-functional stakeholder partnership.
* Assesses labeling changes for MOW for differences in meaning and emphasis and participates in the respective labeling exception approval process with the Global Labeling Committee (GLC) nor non-US/Central EU labeling.
* Helps resolve issues between the countries and Product Care, Quality and Supply Chain related to artwork creation, translation and implementation through use of established processes, systems and best practices.
* Ensures consistent communication to the regions and countries regarding updates to CCDSs that will impact labeling revisions and related implementation.
* Leads the assessment and, as necessary, Global Labeling Committee (GLC) review of proposed exceptions between the CCDS and the MOW labeling when meaning and/or emphasis are changed utilizing established departmental processes.
* Escalates differences and issues to the Director, Global Labeling Operations as necessary.
* Remains up to date with the global labeling requirements and expectations.
* Represents Global Labeling in internal and external meetings as needed.
* Builds effective, cross-functional networks with GRA (regional and global) as well as across functions within Product Care, Quality and the End-to-End Supply Chain.
* Strong knowledge of Regulatory Labeling - CCDS, USPI, EUSmPC and Rest of World
* Hands-on experience in the development of the USPI and its FDA guidance/regulations
* Global exposure working with different regions - Asian Pacific, Middle East, Western and Eastern Europe, Latin America
* Minimum of 5 years of biotech/pharmaceutical industry experience. This is inclusive of 2+ years of labeling/regulatory experience combined with other global responsibilities.
* Experience leading teams in a matrix organization are expected.
* Managing team members is an advantage.
* Knowledge and understanding of principles of regulatory requirements relevant to drug development, global labeling, and post-marketing requirements.
* Demonstrated problem-solving ability able to analyze risk and make appropriate recommendations/decisions.
* Must work well with others and within global teams, particularly cross-cultural exposure. Experience working in a complex and matrix environment is required.
* Organizational skills to interact seamlessly both internally and externally on regulatory compliance matters.
* Proficient regulatory knowledge including an understanding of scientific concepts within labeling and implications across the organization and globally.
* Effective communication skills, specifically related to the explanation of concepts, options, and impact.
* Attention to detail, coupled with the ability to think strategically.
* University degree (4-year degree) in Life Sciences or related Pharmaceutical field (e.g., Chemistry, Engineering); advanced degree (MSc, Ph.D. or Pharm D) helpful.
We are an equal opportunity employer and make hiring decisions based on merit. Recruitment, hiring, training, and job assignments are made without regard to race, color, national origin, age, ancestry, religion, sex, sexual orientation, gender identity, gender expression, marital status, disability, or any other protected classification. We consider all qualified applicants, including those with criminal histories, in a manner consistent with state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.