Labeling Specialist

Description:

Remote As part of Global Labeling Strategy and Compliance (LSC), and under the supervision of the Therapeutic Area Lead, the Labeling Manager is responsible for supporting the facilitation and management of the end-to-end labeling processes for the pre & post marketed products over the product's life cycle. The Labeling Strategist, Manager will lead the development of the Core Labeling documents. and US Labeling deliverables in accordance with Amgen Labeling Processes for assigned therapeutic area(s). Principal responsibilities include, but are not restricted to: - Chairs/leads the Labeling Working Group (LWG), and presents to Executive Labeling Board the labeling documents review/governance - Represents labeling on product-specific global regulatory teams - Leads the development and maintenance of core labeling documents including Core Data Sheet(CDS), core patient information leaflet (CPIL), and core instructions for use (cIFU)and regional labeling such as the US Prescribing Information (USPI), US patient labeling such as the patient prescribing information (PPI) and Medication guide. Manages products with a medium to high degree of complexity from a labeling perspective. - Provides strategic guidance on labeling regulations, requirements, competitor labeling, and labeling trends impacting the LWG and across the regulatory organization. - Advises internal and/or external experts on the creation of high-quality documents supporting changes to the core labeling documents and manages the annotations within those documents - Provides strategic labeling advice for major regions and works with cross functional teams to ensure that the execution of global regulatory labeling plans are aligned with global regulatory strategies - Reviews and approves deviations from core labeling; ensures deviations from labeling procedures and policies are escalated appropriately. - Contributor to strategic creation of target product labeling - Assists in preparation of responses to labeling-related Health Authority queries including supporting Packaging Component Labeling - Manages the review and approval of core DHCP letters - Contributes to Annual Reports/ DSURs/ PBRERs/ Product Quality Complaint reviews. Preferred Qualifications: - Degree in pharmaceuticals, natural science or medicine - Experience in Pharmaceutical, Biotechnology and/or Medical Device industry and product labeling - Knowledge of labeling within a Therapeutic Area - Knowledge of FDA, or EMA, or other international regulations for labeling - Understanding the impact of emerging trends and their implications for Amgen - Project Management experience, experience managing individual and group projects of moderate complexity - Strong collaboration, presentation, communication, interpersonal, and leadership skills - Experience working in a Veeva/Documentum-based document management system Knowledge & Skills: - Knowledge of global labeling regulatory requirements, standards and processes - Understanding of product development is required, and a solid understanding of biology and pharmacology relevant to the therapeutic area - Analytical thinking - Ability to develop solutions that are thorough, practical, and consistent with functional objectives. - Strong collaboration, interpersonal and negotiation skills. - Demonstrable conflict resolution and negotiation skills - Meeting facilitation and presentation skills - Attention to detail, time management, organizational skills - Excellent verbal, and written communication skills. - Strong technical writing skills - Proficiency utilizing Microsoft Suite - Outlook, Word, Excel, PowerPoint Day to Day: - Chairs/leads the Labeling Working Group (LWG), and presents to Executive Labeling Board the labeling documents review/governance - Represents labeling on product-specific global regulatory teams - Leads the development and maintenance of core labeling documents including Core Data Sheet(CDS), core patient information leaflet (CPIL), and core instructions for use (cIFU)and regional labeling such as the US Prescribing Information (USPI), US patient labeling such as the patient prescribing information (PPI) and Medication guide. Manages products with a medium to high degree of complexity from a labeling perspective. - Provides strategic guidance on labeling regulations, requirements, competitor labeling, and labeling trends impacting the LWG and across the regulatory organization. - Advises internal and/or external experts on the creation of high-quality documents supporting changes to the core labeling documents and manages the annotations within those documents - Provides strategic labeling advice for major regions and works with cross functional teams to ensure that the execution of global regulatory labeling plans are aligned with global regulatory strategies - Reviews and approves deviations from core labeling; ensures deviations from labeling procedures and policies are escalated appropriately. - Contributor to strategic creation of target product labeling - Assists in preparation of responses to labeling-related Health Authority queries including supporting Packaging Component Labeling - Manages the review and approval of core DHCP letters - Contributes to Annual Reports/ DSURs/ PBRERs/ Product Quality Complaint reviews.

Skills:

labelling, regulatory affairs, regulatory, fda, gmp, pma, regulatory submission, veeva, pharmaceutical, pharmaceutical industry, document control, quality systems management, regulatory documents, regulatory compliance, medical device

Top Skills Details:

labelling,regulatory affairs,regulatory,fda,gmp,pma,regulatory submission,veeva,pharmaceutical,pharmaceutical industry,document control,quality systems management,regulatory documents,regulatory compliance,medical device

Additional Skills & Qualifications:

Basic Qualifications: Doctorate degree OR Master's degree and 2 years of related experience OR Bachelor's degree and 4 years of related experience OR Associate's degree and 10 years of related experience OR High school diploma / GED and 12 years of related experience Knowledge & Skills: - Knowledge of global labeling regulatory requirements, standards and processes - Understanding of product development is required, and a solid understanding of biology and pharmacology relevant to the therapeutic area - Analytical thinking - Ability to develop solutions that are thorough, practical, and consistent with functional objectives. - Strong collaboration, interpersonal and negotiation skills. - Demonstrable conflict resolution and negotiation skills - Meeting facilitation and presentation skills - Attention to detail, time management, organizational skills - Excellent verbal, and written communication skills. - Strong technical writing skills - Proficiency utilizing Microsoft Suite - Outlook, Word, Excel, PowerPoint

Experience Level:

Entry Level

About Aston Carter:

Aston Carter provides world-class corporate talent solutions to thousands of clients across the globe. Specialized in accounting, finance, human resources, talent acquisition, procurement, supply chain and select administrative professions, we extend the capabilities of industry-leading companies. We draw on our deep recruiting expertise and expansive network to meet the evolving needs of our clients and talent community with agility and excellence. With offices across the U.S., Canada, Asia Pacific and Europe, Aston Carter serves many of the Fortune 500. We are proud to be a ClearlyRated Best of Staffing® double diamond winner for both client and talent service.

Diversity, Equity & Inclusion

At Aston Carter, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

+ Hiring diverse talent

+ Maintaining an inclusive environment through persistent self-reflection

+ Building a culture of care, engagement, and recognition with clear outcomes

+ Ensuring growth opportunities for our people

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

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