Job Closed

This listing is no longer active.

Amgen logo
Amgen

#WeareBiotech

Labeling Strategist, Manager

ManagerManagerOtherRemoteSeniorTeam 10,001+Since 1980H1B SponsorCompany SiteLinkedIn

Location

United States

Posted

114 days ago

Salary

$113.4K - $155.5K / year

Seniority

Senior

Bachelor Degree4 yrs expExperience acceptedEnglish

Job Description

Labeling Strategist, Manager

Amgen

• Authors (user friendly, international language, consistent across products) and maintains core labeling documents including cCDS, cPIL, and cIFU in addition to dCDS, dIFU, USPI, and medguide • Chairs/leads the Labeling Working Group, and presents to Executive Labeling Board • Provides strategic guidance on labeling regulations, requirements, competitor labeling, and labeling trends • Advises internal and/or external specialists on the creation of high quality documents supporting changes to the core labeling documents and runs 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. • Works with customer experience, packaging engineering, branding, HF, and artwork center to create layout templates for use in HF studies • Represents labeling on product-specific global regulatory teams

Job Requirements

  • 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
  • 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
  • Collaboration, presentation, communication, interpersonal, and leadership skills
  • Experience working in a Documentum-based document management system.

Benefits

  • A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions
  • group medical, dental and vision coverage
  • life and disability insurance
  • flexible spending accounts
  • A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
  • Stock-based long-term incentives
  • Award-winning time-off plans
  • Flexible work models where possible.

Related Categories

Related Job Pages

More Manager Jobs

International SOS logo

Bilingual Service Delivery Manager

International SOS

International SOS is the world's leading health and security risk services company. Worldwide Reach, Human Touch.

Manager114 days ago
OtherRemoteTeam 10,001+Since 1985H1B Sponsor

This description is a summary of our understanding of the job description. Click on 'Apply' button to find out more. Role Description This is a newly created permanent position. The Bilingual Service Delivery Manager is responsible for leading and managing the day-to-day operations of the Service Delivery team across travel and lifestyle services in both English and French. This role ensures the delivery of exceptional client experiences, meets business and quality goals, and fosters employee engagement. The manager will coach and develop high-performing teams, drive operational excellence, and support strategic initiatives to exceed client expectations and contractual commitments. Qualifications - Minimum 5 years in travel, lifestyle, or hospitality services. - Minimum 5 years managing teams of 15+ in a call center environment. - Must possess relevant Supervisor Travel Industry Certification in accordance with local requirements. - Experience with travel programs (air/hotel) and B2B models preferred. - Bachelor’s degree or equivalent experience required. - Highly proficient communication in English (verbal and written) required. - Proficient communication in French (verbal and written) required. Requirements - Strong professional presence and communication skills. - Travel GDS and CRM knowledge. - Comprehensive understanding of relevant Travel Industry specific standards and regulations. - Ability to thrive in fast-paced, evolving environments. - Strategic leadership, delegation, and coaching capabilities. - Business acumen and client trust-building. - Proficiency in MS Office (Word, Excel, PowerPoint, Outlook, Visio). Benefits - This position is a non-travel position. - Flexible schedule, including evenings, based on business needs. Work Environment & Physical Requirements - Must have a dedicated, quiet, and private workspace free from distractions. - Ability to sit and remain at a desk for extended periods (up to 8 hours per day) while operating a computer and telephone headset. - Reliable high-speed uninterrupted internet connection meeting minimum company standards. - Ability to use hands and fingers to operate a computer keyboard, mouse, and other office equipment. - Clear, polished and professional verbal & written communication and active listening skills to effectively interact with clients and team members. - May occasionally require walking, standing, or light lifting (up to 10 pounds) of equipment such as a laptop or office supplies. Aspire Lifestyles is dedicated to providing accessible services to all individuals, including those with disabilities. Accommodations are available upon request throughout the selection process.

United States
Job Closed
OtherRemoteTeam 10,001+Since 1982H1B No Sponsor

• Lead, coach, and develop a team of business analysts, providing technical guidance and thought leadership to deliver high‑quality, scalable analytic solutions • Act as the HCC and Stop Loss subject matter expert for cross‑functional partners, informing strategy, decision‑making, analytic direction and adoption paths for Stop Loss data assets and insights • Development of foundational stop loss analytic assets and insights • Stop loss and HCC analytics, including product performance and ad hoc analyses across high‑cost drivers, emerging trends, pooling behavior, financial impacts, attachment point dynamics, broker insights, and risk signals; evolve existing analytics and develop new capabilities • Translate complex business questions into clear analytic and data requirements, delivering actionable insights that drive business outcomes • Ensure strong data quality, governance, and controls, reconciling analytic assets to financial sources of truth and driving continuous improvement in data integrity and accessibility • Drive automation and modernization of analytic processes through SQL optimization, data engineering best practices, and close collaboration with Technology and Data Science partners • Communicate insights, implications, and recommendations to senior leaders through clear, concise, and compelling storytelling

Connecticut
$130.9K - $218.1K / year
Job Closed
Neighbors, Inc. logo

Mortgage Servicing Manager

Neighbors, Inc.

Providing opportunities for our neighbors to thrive by connecting volunteers to people in need.

Manager114 days ago
OtherRemoteTeam 11-50Since 1972H1B No Sponsor

• Overseeing interim and sub-servicing operations to ensure alignment with internal processes, investor guidelines, and regulatory standards • Managing relationships with external servicing partners and future GSE relationships, ensuring contractual obligations and service levels are met • Monitoring servicing workflows, KPIs, reporting, and trend data to identify risks, gaps, or recurring issues • Escalating findings when expectations are not met and driving root cause analysis through to resolution • Leading servicing-related initiatives, projects, and system enhancements from planning through execution • Collaborating cross-functionally with Secondary, Compliance, Production, Finance, and Operations teams • Developing, documenting, and refining servicing policies and procedures to support long-term scalability • Creating reporting visibility that enables leadership to make informed decisions

Alabama + 12 moreAll locations: Alabama | Arizona | Florida | Idaho | Iowa | Kansas | Montana | Oklahoma | Mississippi | Missouri | Texas | Utah | Virginia
$70K - $90K / year
Job Closed
OtherRemoteTeam 51-200H1B No Sponsor

• Responsible for demand forecasts across all channels (DTC, DME, retail, and distributor) and customer care support, in all regions and global markets • Develop and maintain an 18-month rolling forecast at the SKU, channel, region level to inform global supply chain purchasing decisions • Identify demand risks and opportunities early and proactively recommend mitigation actions • Own and manage the global demand planning calendar, ensuring forecasts are timely, complete, and aligned with commercial and operational objectives • Lead the demand pillar of S&OP/IBP, ensuring alignment across Commercial, Supply Chain, Finance, and regional stakeholders • Partner closely with the regional sales teams to incorporate pipeline, promotional plans, launches, and market intelligence into the forecast • Collaborate with Product & Marketing teams on NPI, campaigns, and demand-shaping activities • Work with Supply Planning and Finance to align demand plans with capacity, inventory targets, and financial forecasts • Analyze historical sales, promotions, product lifecycle, and market trends to improve forecast accuracy • Develop, track, and report on key demand KPI’s including MAPE and forecast bias, at the market, SKU level • Identify trends, variance, and root causes of forecast error, and implement corrective actions • Drive data integrity and reporting accuracy to support decision-making • Conduct scenario planning for new products, market expansion, and promotions • Drive continuous improvement in forecast systems, tools, and processes, to improve visibility, agility, and decision-making

United States