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Amgen is a leading independent biotechnology company focused on developing innovative human therapeutics to address serious illnesses. Founded in 1980, Amgen leverages advanced human genetics and biologics manufacturing expertise to improve health outcomes and enhance the quality of life for patients worldwide.

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🏢 Amgen
đź’° $28,500,000,000 Post-IPO Debt over 2 years agođź«‚ Last layoff over 1 year agoBiotechnology Research
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Jobs at this company:

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đź“Ť United States

đź’¸ 156353.0 - 184355.0 USD per year

🔍 Bio-pharmaceutical

  • Bachelor’s degree and 6 years of Marketing and/or business experience in a role aligned with a Marketing/Sales commercial organization
  • MBA in marketing, healthcare management, or related fields (preferred)
  • 5+ years of experience in a series of commercial roles of increasing scope, scale, and complexity within the bio-pharmaceutical industry (preferred)
  • Experience engaging hospital or IDN systems, opinion leaders, and organizations to achieve marketing goals (preferred)
  • Demonstrated success in working across teams in a highly matrixed, fast-paced environment. Effective communication, platform, and facilitation skills.
  • Experience in managing vendors, agencies, and marketing projects (preferred)
  • Strong understanding of legal and regulatory environment in pharmaceutical promotions, pharma industry guidelines, and other compliance-related issues (required)
  • Proven experience in developing and implementing clinical marketing programs tailored for primary care audiences (preferred)
  • Strong business acumen, analytics, and critical thinking skills (required)
  • Cardiology, primary care, or hospital / IDN sales or marketing experience strongly preferred.
  • Partner with Marketing, External Medical Engagement, Corporate Communications, Medical, Advocacy and more to impact national, institutional, and individual customers in increasing LDL-C testing and guideline directed cardiovascular care
  • Partner with field teams on key tactics, program development, and material creation
  • Engage with external opinion leaders and internal colleagues to execute and evolve above brand scientific exchanges that inspire changes across Integrated Delivery Networks. Serve as primary conduit for all LDL-C Action Forums.
  • Develop, deploy, and measure targeted insightful messaging and educational resources tailored to advance Amgen’s above brand priorities. Partner with external cardiac and primary care organizations to deliver targeted disease state education for patients and providers
  • Apply market research and insights to drive disease state strategy and execution for primary care customers
  • Work with third-party vendors to facilitate the internal legal, regulatory and medical review of marketing materials via the Materials Approval and Compliance (MAC)
  • Collaborate with cross-functional teams, including sales, global commercial capabilities and cDNA, to align marketing strategies with overall business goals
  • Manage projects through the legal, regulatory, and medical review process to ensure compliance and effectiveness

Project ManagementBusiness IntelligenceData AnalysisCross-functional Team LeadershipCommunication SkillsAnalytical SkillsPresentation skillsComplianceSales experienceMarket ResearchData visualizationMarketingTeam managementStakeholder managementStrategic thinkingDigital MarketingCRMFinancial analysisBudget management

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đź“Ť United States of America

đź’¸ 196773.0 - 249710.0 USD per year

🔍 Bio-pharmaceutical

  • Doctorate degree and 5 years of compliance, legal or a control function supporting a bio-pharmaceutical business experience
  • Or Master’s degree and 8 years of compliance, legal or a control function supporting a bio-pharmaceutical business experience
  • Or Bachelor’s degree and 10 years of compliance, legal or a control function supporting a bio-pharmaceutical business experience
  • five years of experience with buy-and-bill and/or patient support services model
  • Prior experience as the lead strategic compliance or legal advisor for a bio-pharmaceutical medicine
  • Deep understanding of the biotechnology industry and healthcare compliance environment (US required, plus additional major markets preferred)
  • Experience navigating drug approvals, data milestones and regulatory decisions
  • Demonstrated skills in delivering strategies and results in a complex organization
  • Ability to prioritize resources and effectively communicate with leadership
  • Strong written, spoken and interpersonal communication skills with attention to detail; polished, poised presenter
  • An exceptional team leadership and talent development track record
  • Strong critical thinking, problem-solving and planning skills
  • Collaboratively work with a diverse group of people and backgrounds
  • Drive solutions that empower our colleagues to elevate ethical decision-making and honorably secure patient access for our current and future patients
  • Proactively support and anticipate business needs by embedding in both the senior leadership team and their individual leadership teams
  • Develop multi-dimensional compliance strategies tailored to the unique circumstances and needs of each RDBU business that incorporate learnings from monitoring, investigations, business engagement and industry actions
  • Harness purposeful relationship building and develop trust to engender buy-in with leaders by developing rapport, participating, listening and learning
  • Possess unique understanding of the rare landscape and regulatory environment to thoughtfully and open-mindedly advise the Rare Disease Business Unit
  • Lead and develop a team of compliance officers to elevate the support of the business
  • Embrace ambiguity and adeptly navigate the evolving risk paradigm with agility, confidence and intentionality
  • Influence within WC&BE and across RDBU and cross-functional partners to facilitate collaborative decision-making that elevates and ethically meets patient needs
  • Confidently problem-solve, including knowing when to escalate potential challenges, and quickly learn how to work within a matrixed organization
  • Be prepared to travel to major conferences, internal trainings and meetings for WC&BE or RDBU, as well as to Amgen sites in the U.S. or globally

LeadershipCross-functional Team LeadershipCommunication SkillsMentoringNegotiationWritten communicationComplianceInterpersonal skillsRelationship buildingProblem-solving skillsTrainingRisk ManagementTeam managementStrategic thinkingData analytics

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đź“Ť United States

🧭 Full-Time

đź’¸ 139938.0 - 151888.0 USD per year

🔍 Pharmaceutical

  • Extensive regulatory affairs knowledge and familiarity with RA concepts, procedures, practices, and industry standards.
  • Knowledge of global labeling regulatory requirements, standards and processes.
  • Demonstrated understanding of product development is required, and a comprehensive understanding of biology and pharmacology relevant to the therapeutic area.
  • Analytical thinking and critical judgment.
  • Ability to work and manage multiple assignments and timeline driven priorities.
  • Substantial project management skill, with demonstrated ability in planning, implementing, and executing tasks to meet RA goals.
  • Ability to independently develop solutions that are thorough, practical, and consistent with functional objectives.
  • Demonstrated ability to lead teams.
  • Interpersonal, organizational and negotiation skills.
  • Strong technical writing skills.
  • Strong collaboration, presentation, verbal and written communication, interpersonal, and leadership skills.
  • Demonstrable conflict resolution and negotiation skills.
  • Excellent project management, and attention to detail.
  • Experience working in a Regulatory Information Management system.
  • Proficiency utilizing Microsoft Suite – Outlook, Word, Excel, PowerPoint.
  • Degree in life science or medicine
  • Experience in Pharmaceutical Industry Regulatory Affairs and /or product labeling
  • Expertise in product labeling within a Therapeutic Area
  • Knowledge of FDA, EMA, and other international regulations for labeling
  • Experience in managing individual and group projects of high to moderate complexity
  • Experience working in a Veeva/Documentum-based document management system
  • Chairs/leads Labeling Working Group and presentations to Cross-Functional Executive Labeling Board meetings.
  • 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.
  • Represents labeling on product-specific global regulatory teams and informs on GRT decision which impact any relevant portfolio assets,
  • Provides input and leads the strategic guidance to Target Product Labeling,
  • Manages compounds with a medium to high degree of complexity from a labeling perspective.
  • Provides strategic guidance on labeling regulations, requirements, competitor labeling, and labeling trends to other Labeling Strategist 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 provides feedback and approves deviations from core labeling.
  • Ensures deviations from labeling procedures and policies are escalated appropriately.
  • Assists in preparation of responses to labeling-related Health Authority queries.
  • Manages the review and approval of core DHCP letters.
  • Contributes to Annual Reports/ DSURs/ PBRERs/ Product Quality Complaint reviews.
  • Collaborates on provides tangible solutions to labeling issues.
  • Supervises direct reports and supports their career development, if applicable.
  • Represents labeling on product-specific global regulatory teams.

LeadershipProject ManagementProject CoordinationCommunication SkillsAnalytical SkillsCollaborationWritten communicationComplianceInterpersonal skillsExcellent communication skillsNegotiation skillsStrong communication skillsCross-functional collaborationRisk ManagementStrategic thinkingData analytics

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đź“Ť United States of America

đź’¸ 126027.0 - 155005.0 USD per year

🔍 Marketing

  • Strong marketing fundamentals with a solid grasp of marketing strategy, market research, brand positioning, and tactical plan development.
  • Experience marketing directly to consumers, with a preference for experience within pharmaceutical or regulated consumer goods or services.
  • Experience developing multicultural marketing strategies
  • Experience developing and performing a wide range of successful online and offline tactics, including digital, print, video, and CRM.
  • Translating market research into effective consumer campaigns or programs. Previous experience with clinical data a plus.
  • Exhibiting passion and empathy to build important experiences with consumers by understanding their needs and desires.
  • Experience working with advertising agencies to develop and produce engaging creative.
  • Strong bias for action and ability to prioritize in a fast-paced environment.
  • Ability to exercise excellent judgment and live up to the highest ethical standards.
  • Excellent communication skills and self-awareness of leadership style.
  • Ability to build positive relationships and collaborate effectively in a matrixed organization.
  • Lead execution of branded campaign tactics across DTC ecosystem (website, social media, search, digital, point-of-care, email and others) for General Market and Multicultural audiences.
  • Own website performance, including refreshing measurement framework and dashboards, aligning metrics with brand and media KPIs.
  • Execute paid and organic social media strategy - including role of channels, innovative opportunities, creative strategy, content calendar, and new channel expansions.
  • Drive digital channel innovation through partnership with internal SMEs, optimizing engagement dynamically across channels
  • Build insightful DTC communications – in close collaboration with market research and agency partners to uncover deep insights and translate them to compelling creative and messaging that is well coordinated across channels
  • Consult on media strategy – own tactical optimizations for select channels and partner with Senior Manager to implement the overall media strategy, including support of planning, placement, optimizations, and measurements/insights across key channels
  • Collaborate with key partners including HCP Promo marketing, Patient Access, Corporate Communications, Advocacy, Scientific Communications, Global Commercial Capabilities, and Commercial Data and Analytics to ensure synergy with programming for healthcare professionals, customers, and consumers.
  • Lead the internal legal, regulatory, and medical review and approval of new materials to enable responsible and compliant consumer communications.
  • Support budget stewardship within the team, closely monitoring performance and ensuring cost-effective delivery of projects
  • Play a part in building a winning, inclusive and encouraging team culture.

Project ManagementData AnalysisContent creationStrategic ManagementCommunication SkillsAnalytical SkillsCollaborationSEOPresentation skillsBudgetingCross-functional collaborationMarket ResearchMarketingStakeholder managementDigital MarketingCRMData analyticsCustomer Success

Posted 2 days ago
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đź“Ť United States

🧭 Full-Time

đź’¸ 156353.0 - 184355.0 USD per year

🔍 Marketing

  • Ability to effectively communicate and engage with external customers as well as internal cross-functional partners
  • Sales experience and/or experience effectively partnering with sales teams
  • Excellent verbal and written communication skills, including listening and presentation skills
  • Demonstrated ability to effectively produce business results, strong project management skills and ensure flawless execution
  • Ability to drive influence across cross-functional team members to set direction and align work efforts
  • Marketing competence with a solid grasp of marketing strategy, market research, segmentation, brand positioning, and tactical plan development
  • Exhibiting passion and empathy to build meaningful experiences with HCPs by understanding their needs and desires
  • Experience developing and implementing HCP facing marketing tactics
  • Demonstrated strength in analytics to translate data into insights and indicated actions
  • Creative and innovative, while also possessing analytical problem-solving skills
  • Experience working with creative agencies
  • Ability to exercise strong judgment and live up to the highest ethical standards
  • Ability to build productive partnerships and collaborate effectively in a matrix organization
  • Proactive, results-oriented self-starter motivated by a challenging task
  • Strong organizational skills - to set targets, track to achievements and complete projects
  • Evolve a customer engagement plan to drive brand growth in key accounts, segments and geographies
  • Identify and track key insights in key accounts, segments and geographies to inform brand performance, growth potential and customer needs
  • Create and lead execution of innovative custom tactics for prioritized accounts and geographies to deliver against key customer insights.
  • Develop and implement external engagement and peer-to-peer initiatives (live and digital)
  • Evolve opinion leader strategy by partnering closely with cross-functional partners
  • Develop, continually refine and implement the Blincyto speaker program strategy and tactics
  • Develop, continually refine and implement the Blincyto congress strategy
  • Lead the planning, development, and execution of generating HCP insights
  • Partner closely with Legal and Regulatory teams
  • Identify and track robust Key Performance Indicators and lead/lag indicators
  • Establish relationships with all agency partners and internal downstream operational partners

LeadershipProject ManagementData AnalysisCross-functional Team LeadershipCommunication SkillsAnalytical SkillsPresentation skillsWritten communicationComplianceNetworkingExcellent communication skillsAccount ManagementVerbal communicationBudgetingCross-functional collaborationSales experienceMarket ResearchMarketingTeam managementStakeholder managementStrategic thinkingDigital MarketingCRMBudget management

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đź“Ť United States

đź’¸ 121739.0 - 143337.0 USD per year

🔍 Pharmaceutical or Biotech

  • Doctorate Degree OR Master's Degree and 2 years of clinical experience OR Bachelor's Degree and 4 years of clinical experience OR Associate's degree and 8 years of clinical experience OR High school diploma/GED and 10 years of clinical experience
  • Degree in life science, computer science, business administration or related field (Preferred)
  • Clinical Data, Project and Planning Management experience in the Pharmaceutical or Biotech industry (Preferred)
  • Experience in oversight of outside vendors (CRO’s, central labs, imaging vendors, etc.) (Preferred)
  • Project level coordination of and day to day oversight of DM tasks including: Review all DM documents within a project area to ensure a consistent approach and review of project timelines and metrics to ensure databases are delivered to set timelines, and approve database locks and unlocks.
  • Ensure that quality control checks are occurring such that quality databases are delivered.
  • Develop and co-ordinate project level training for data management staff.
  • Review and approve study specific training and lead vendor results and relationship at the project level.
  • Communication of project level issues including processes, timelines, resourcing, performance, etc.
  • Review of all study level non-DM documents for awareness and project level consistency.
  • Lead electronic submission activities and assist with response to questions and findings from Clinical Quality Assurance (Quality Assurance) and other audits at the study / vendor level.
  • Lead or participate in the development, review and implementation of processes, policies, SOPs and associated documents affecting DM.

LeadershipProject ManagementProject CoordinationCross-functional Team LeadershipCommunication SkillsQuality AssuranceData management

Posted 3 days ago
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đź“Ť United States

đź’¸ 165889.0 - 200119.0 USD per year

🔍 Biopharmaceutical

  • Early and late stage drug development experience, including deep experience in one or more core drug development and commercialization functions
  • Experience leading teams through business case development, lifecycle management planning, and complex governance processes
  • Program and project management skills with experience in a healthcare-related environment, operationalizing critical initiatives, including cross-functional strategic planning, development of integrated plans, and driving execution to plan
  • Strong communication, including influencing without authority and navigating within a matrixed environment
  • Experience using Project Management tools, methodologies, practices, and infrastructure, as related to the Biopharmaceutical Industry
  • Partners with functional leads to develop high quality, integrated, cross-functional plans for cross-functional sub-teams that are aligned with the overall program strategy
  • Facilitates the strategic development of Clinical Development Plans for new patient impact expansion opportunities
  • Ensures cross-functional alignment and accountability
  • Drives the development and timely completion of annual WPT goals and input to the Global Product Strategy
  • Facilitates resource planning, financial, and capacity assessments, as needed
  • Documents issues, decisions, and action items of functional work package teams and ad hoc project team meetings
  • Conducts the risk management and scenario planning and develops contingency and/or risk mitigation plans
  • Coordinates activities with external business partners and alliances, where applicable; contributes to a successful partnership outcome

Project ManagementAgileData AnalysisCross-functional Team LeadershipFinancial ManagementResource PlanningCommunication SkillsCollaborationMicrosoft ExcelProblem SolvingMentoringNegotiationWritten communicationInterpersonal skillsMS OfficeBudgetingStrong communication skillsRisk ManagementTeam managementStakeholder managementChange Management

Posted 3 days ago
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đź“Ť United States

đź’¸ 82984.0 - 103629.0 USD per year

  • Experience in Leadership and/or management role.
  • An understanding of the pharmaceutical commercialization process and knowledge of the legal and regulatory guidelines affecting promotion of prescription products
  • Project management experience in the Pharmaceutical, Biotechnology, Healthcare-related field, or other regulated industries
  • Experience with Microsoft Office 365 (e.g. Word, Excel, Outlook, and PowerPoint), Adobe products (e.g. Adobe Photoshop, Illustrator, and Acrobat Pro), and Veeva PromoMats
  • Experience in leading the creation of marketing materials from concept to commercialization.
  • Experience managing the approval process of marketing materials that are produced at high volumes.
  • Copy-Editing experience including excellent typing and spelling skills.
  • Able to proofread materials using Adobe Acrobat Professional
  • Lead 1 MAC Team: Provide process guidance/ system pathways and issue resolution when issues arise to the MAC Team and Cross Functional Partners
  • Manage MAC, Office Hours, and Prioritization
  • Partner with Commercial Director and Brand teams
  • Manage elevation process
  • Ensure compliance along all phases of the MAC process
  • Serve as a neutral partner to ensure business needs are met
  • MCM Back-Up Coverage
  • Leads Global Initiative/Other Project
  • Plans and executes with minimal direction

Project ManagementCross-functional Team LeadershipComplianceExcellent communication skillsClient relationship managementSales experienceMarketingStakeholder management

Posted 3 days ago
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đź“Ť United States of America

đź’¸ 148812.0 - 189167.0 USD per year

🔍 Rare Disease

  • Prior experience in contracts and pricing, direct payer experience or value marketing
  • Excellent conceptual problem-solving skills
  • Authoritative command of complexity and ambiguity; ability to see the big picture; ability to collect, digest and assemble information to enable relevant business analyses
  • Ability to work independently and achieve results with multiple competing priorities
  • Strong leadership skills with a demonstrated ability to influence different styles
  • Previous experience building financial models and/or working with large amounts of data
  • Experience navigating the evolving U.S. healthcare system with specific interest on the interactions between Government and Healthcare.
  • Exceptional written/oral communication skills and executive presence across functions and across different levels of leadership
  • Develop and take ownership of access strategies for key rare disease products
  • Support Latest Estimate Discount Rate (LEDR) process, pricing and contracting scenarios, contract decisions, and LRS management
  • Partner with cross-functional partners to align on account level payer strategy and negotiations
  • Engage in competitive scenario planning and analysis across upcoming launches
  • Track Market Access payer coverage goals and annual access KPIs and activate teams to establish, improve, and protect medical coverage policies
  • Create access marketing materials and route through the MAC-approval process. Coordinate with Training to rollout materials to customer facing teams for execution.
  • Routinely interact with senior leadership and other high-level, cross functional committees or teams
  • Ensure alignment in strategy and execution of the plan with cross-functional teams including Brand, Medical, Patient Access, Value Marketing, HEOR, CfOR, Trade & Distribution, Legal, Government Affairs & Policy, Advocacy and more
  • Build and maintain positive relationships with collaborators; proactively seeks buy-in and provides ongoing support to address business needs
  • Constructively challenge teams by providing both confirming and disconfirming information and encouraging innovative problem solving

LeadershipData AnalysisCross-functional Team LeadershipStrategyCommunication SkillsNegotiation skillsBudgetingStakeholder managementStrategic thinkingFinancial analysisData modeling

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đź“Ť United States

đź’¸ 113254.0 - 143293.0 USD per year

🔍 Pharmaceutical, Biotechnology or other Healthcare-related field

  • 10+ years of experience in the Pharmaceutical, Biotechnology or other Healthcare-related field
  • Direct CMC experience
  • Experience in an environment requiring one to foster collaboration and work effectively on cross-functional teams
  • Strong interpersonal and communication experience with the ability to effectively interface across all levels of the organization
  • Experience applying critical thinking and problem-solving skills to achieve results
  • Experience applying standard Project Management tools, and practices
  • Experience with MS Project, Excel and SharePoint
  • Work with technical and/or Product Delivery Teams by creating project timeline that align with PD prioritization
  • Support projects that apply internal and external personnel, contract firms, and partners
  • Assist PD in driving decision making using DAI principles (D- Decision maker, A- Advice Giver, I- Informed) by producing risk analyses and scenario planning
  • Ensure participation in functional and cross-functional management reviews
  • Establish and manage collaboration and team SharePoint sites
  • Provide meeting management support including meeting planning, scheduling, facilitation, documentation (development of meeting agenda and minutes), and outcomes communication
  • Ensure product project reporting to Product Lifecycle Management (PLM)
  • Manage and prioritize support of multiple project teams at one time
  • Facilitate and incorporate lessons learned, standard methodologies, etc.
  • Support business process improvements

Project ManagementAgileData AnalysisSharePointProject CoordinationCross-functional Team LeadershipBusiness OperationsCommunication SkillsAnalytical SkillsCollaborationTime ManagementProblem-solving skillsTeamworkRisk ManagementStakeholder managementStrategic thinkingProcess improvementData managementChange Management

Posted 4 days ago
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