Jobs at Novo Nordisk
34,827 open positions
Manager- Business Assurance
Company: Novo Nordisk
Location: Other US Location
Posted Mar 15, 2024
<p><b>About the Department <b> <br >The Finance and Operations dept brings insights and intelligence to inform decision making amp drives digitalization and business solutions to attain NNI goals Finance and Operations works closely across the organization to guide enterprisewide resource allocations investment choices drive core operations and develop insights to drive growth and operational excellence across the value chain while innovating for future capabilities Our focus on innovation ensures were constantly building future capabilities Were responsible for regulating accounting upholding workplace safety managing our supply chain and sampling supporting technological and data innovation insights and analytics delivering patient support solutions maintaining our facilities and assuring the integrity and completeness of all business transactions At Novo Nordisk you will have the opportunity to build a lifechanging career in a global business environment We encourage our employees to make the most of their talent and we reward hard work and dedication with opportunities for continuous learning and personal development Are you ready to maximize your potential with us <br ><b> The Position <b><br >This position is part of the business assurance function for Commercial Part D amp Managed Care contracts This role is responsible for ensuring the validation of formulary eligibility for invoicing of all Commercial and Part D rebates as well as effectuating all business assurance initiatives including but not limited to utilization management controls 340B compliance and contract compliance <br ><b> Relationships <b> <br >This individual contributor role reports to the Sr Manager of Business Assurance and works closely with various teams in PCOR amp Market Access as well as field and home office management External relationships include partnership with Novo Nordisk Global Service Center formulary validation team managed care customers field sales personnel and system vendors <br ><b>Essential Functions<b> <br ><p><ul><li> Accountable for formulary compliance research including review of preferred drug lists and plan policy documents <li> <li> Monitor formulary compliance to ensure contract profitability as well as contract compliance by the customer <li> <li> Provides analysis support around commercial rebate exclusions formulary compliance and utilization management controls and reports out to internal leadership and account teams <li> <li> Provide recommendations to Strategic Pricing team on formulary research findings to improve contract strategies <li> <li> Ensuring compliance between contractual exclusion language and contract set up in the thirdparty system <li> <li> Monitoring 340B compliance as well as calculation of thirdparty fees related to identification of 340B duplicate discounts <li> <li> Works with external vendors on enhancements to validation tool andor exclusion processes <li> <li> Works with Account Executives and customers to verify formulary discrepancies as well as resolve open disputes <li> <li> Demonstrates knowledge of internal business operations and applies this knowledge to analyses processes and deliverables <li> <li> Consistently follows company policies and procedures to ensure compliance with all guidelines Sarbanes Oxley compliance regulations and policies <li> <li> Identifies opportunities and makes recommendations for optimal performance processes and compliance improvement <li> <li> Trains and mentors new team members in the areas of systems processes analytic models and presentations <li> <li> Leads with excellent communication and interpersonal skills and demonstrates effectiveness at working with stakeholders <li> <ul><p><br ><b>Physical Requirements<b> <br >010 overnight travel required <br ><b>Qualifications<b> <br ><p><ul><li> Bachelors degree preferred relevant experience may be substituted for degree when appropriate <li> <li> Requires a minimum of 6 years of progressively responsible relevant experience at least 3 years in pharmacy or medical claims formulary analysis contract analysis rebate administration or utilization management controls required <li> <li> Indepth knowledge of US healthcare systems amp strong understanding of payer formulary concepts and processes required <li> <li> Ability to perform analysis identify trends and insights and translate into actionable insights required <li> <li> Ability to communicate at all levels of the organization <li> <li> Ability to develop and maintain strong internal and external relationships <li> <li> Demonstrated critical thinking and analytical skills required <li> <li> Attention to detail and readiness to delve into and resolve problems <li> <li> Selfmotivator who seeks to improve accuracy and efficiency of analytical work and business processes <li> <li> Strong proficiency in Excel and Powerpoint required <li> <li> Knowledge of pharmaceutical contracting andor manufacturer rebate processes a plus <li> <ul><p><br >We commit to an inclusive recruitment process and equality of opportunity for all our job applicants <br >At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives backgrounds and cultures We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees the patients we serve and communities we operate in Together were life changing <br >Novo Nordisk is an equal opportunity employer Qualified applicants will receive consideration for employment without regard to race ethnicity color religion sex gender identity sexual orientation national origin disability protected veteran status or any other characteristic protected by local state or federal laws rules or regulations <br >If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply please call us at 18554115290 This contact is for accommodation requests only and cannot be used to inquire about the status of applications<p>
VP of Credit Risk
Company: Novo
Location: New York City, NY
Posted Mar 13, 2024
<div> <p><span>We started Novo to challenge the status quowere on a mission to increase the GDP of the modern entrepreneur by creating the goto FinTech platform for small businesses SMBs Novo is flipping the script of the FinTech world and were excited to lead the small business FinTech revolution<br ><span><p> <p><span>We are looking for people of character Pragmatic and capable people who want to see their work drive better outcomes for small businesses the backbone of our economy You will join our<span><span> team<span><span> and work on the building blocks of everything Novo ships<span><p> <p><span> <span><span>Why Novo<span><p> <ul><li><span>Novo is a rapidly growing series B fintech startup with a missiondriven team thats passionate about helping every small business in America<span><li> <li><span>Positive inclusive supportive culture cheering you on your journey<span><li> <li><span>We work with very new technologies and architecture patterns <span><li> <li><span>We provide learning and development budgets to help you grow and bond with your team <span><li> <li>Able to work from the office 3+ days per week<li> <li><span>Offices in NYC Miami Delaware India and Colombia<span><li> <ul><div> <p><strong>Role Overview<strong><p> <p>We are seeking a dynamic and experienced Vice President Credit Risk to manage our new Credit product line In this role you will oversee the credit risk management function while leading a decision sciences team responsible for the underwriting processes Reporting directly to the CEO you will play a critical role in shaping the risk management strategy and ensuring the soundness of our credit operations The role requires a strong foundation in applied quantitative skills coupled with domain expertise in credit risk management<p> <p><strong>Key Responsibilities<strong><p> <ul><li>Credit amp Business Strategy <li> <ul><li>Develop and execute the overall credit risk management strategy in alignment with business objectives and regulatory requirements<li> <li>Collaborate with Product and Finance to ensure pricing and other elements of the PampL align with business goals<li> <li>Manage key vendor relationships including capital providers bank partners and regulatory bodies<li> <ul><li>Data Modeling <li> <ul><li>Lead the decision sciences team leveraging your expertise in data analytics and modeling to optimize credit decisionmaking processes<li> <li>Drive continuous improvement in risk assessment methodologies<li> <li>Drive model decisioning on other components of the Credit program including recoveryservicing and others<li> <ul><li>Risk amp Compliance Partner with the Risk amp Compliance functions to operationalize robust credit risk policies procedures and controls to mitigate potential losses and maintain compliance with regulatory standards<li> <li>Portfolio Management Analyze the credit portfolios and performance trends to mitigate risk and diversify<li> <li>Product Development Collaborate with product engineering compliance and operations to drive a good customer experience<li> <li>Subject Matter Expert<li> <ul><li>Stay abreast of industry trends regulatory developments and best practices in credit risk management to ensure Novo is at the cutting edge<li> <li>Serve as a subject matter expert on credit riskrelated matters providing guidance and insights to senior leadership and key stakeholders<li> <ul><li>Team Leadership Build and lead a team of data scientists and operators<li> <ul><p><strong>Qualifications<strong><p> <ul><li>Bachelors degree in Finance Economics Statistics Mathematics or a related field advanced degree preferred<li> <li>Minimum of 10 years of experience in credit risk management within the financial services or fintech industry with a focus on small business lending or credit products<li> <li>Proven track record of leadership in datadriven decisionmaking and risk management with experience overseeing underwriting processes and credit risk policies<li> <ul><li>This includes knowledge of scoring models risk rating systems and stress testing techniques to assess the impact of different scenarios on credit portfolios<li> <ul><li>Deep understanding of statistical modeling data analytics and predictive modeling techniques with experience in a data scienceanalytics role<li> <ul><li>Statistical Modeling<li> <ul><li>The ability to build and interpret statistical models is essential for analyzing credit portfolios assessing risk and identifying trends This includes proficiency in regression analysis time series analysis and other advanced statistical techniques to predict creditworthiness and potential default risks<li> <ul><li>Data Analytics<li> <ul><li>This involves proficiency in data manipulation cleaning and visualization techniques using tools such as SQL Python R or Excel<li> <ul><li>Predictive Modeling<li> <ul><li>Building predictive models to forecast credit risk and assess the likelihood of default is a key aspect of the role This involves applying machine learning algorithms such as decision trees random forests logistic regression or neural networks to develop predictive models that help in making informed credit decisions<li> <ul><ul><li>Willing to act as a playercoach especially in early days<li> <li>Strong knowledge of regulatory requirements and compliance standards such as the DoddFrank act anti discrimination and fair lending laws Fair Debt Collections laws and more<li> <li>Excellent communication and interpersonal skills with the ability to effectively collaborate with crossfunctional teams and communicate complex concepts to nontechnical stakeholders<li> <li>Strategic thinker with a resultsoriented mindset and the ability to drive initiatives from conception to implementation<li> <li>Demonstrated leadership capabilities including the ability to mentor and develop highperforming teams<li> <ul><p><strong>What does success look like<strong><p> <p>Success means effectively leveraging datadriven insights to optimize credit decisionmaking processes mitigate risks and drive strategic initiatives to generate a profitable and durable credit program Accomplishing these things will allow our credit program to serve our customers by feeling embedded in their daily business operations <p> <div> <p><em><span>Novo values diversity as a core tenet of the work we do and the businesses we serve We are an equal opportunity employer indiscriminate of race religion ethnicity national origin citizenship gender gender identity sexual orientation age veteran status disability genetic information or any other protected characteristic <span><em><p> <div>
Associate Director - Medical Information - Operations Excellence
Company: Novo Nordisk
Location: Other US Location
Posted Mar 13, 2024
<p><b>About the Department <b> <br >The Clinical Medical and Regulatory CMR department at Novo Nordisk is one of the most diverse and collaborative groups within the organization From healthcareprovider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and new product development CMR is involved The one thing that keeps us all marching to the same beat is our patientcentered focus At Novo Nordisk you will help patients around the world As their needs evolve so does our challenge to find better and more innovative ways to improve their quality of life Were changing lives for a living Are you ready to make a difference <br ><b>The Position<b> <br >Direct the business process improvement activities of Medical Information by optimizing and modernizing systems procedures and processes Support both current and future medical information activities to drive productivity and efficiency Act as an internal consultant to understand the needs of the Medical Information team build relationships and a collaborative environment and developimplement innovative solutions that address the needs of the business Maintain an understanding of trends in the Medical InformationMedical Affairs pharmaceutical industry landscape and demonstrate a strong working knowledge of digital communication and technology trends <br ><b>Relationships<b> <br >Reports to a Director level position in Medical Information and has a strong interface with MI leadership <br >Key internal stakeholder relationships include the NNI Medical Information team NNI IT Patient Customer Care Center Patient Safety Medical Affairs <br >External relationships include existing Medical Information vendors digital solution vendors external scientific communications agencies related professional societiesorganizations including industry consortia <br ><b>Essential Functions<b> <br ><p><ul><li> Serves as system owner of current and future state operations platforms and technologies Responsible for the Medical Information Customer Relationship Management CRM system Content Management CM system Global Medical Information platform telephony tools and other systems utilized by the Medical Information team <li> <li> Develops bestinclass capabilities for the execution of Medical Information customer centric medical communication by establishing system requirements processes and procedures identifying platforms and preferred suppliers and developing a future capabilities roadmap <li> <li> Establishes and enforces governance procedures to ensure CRM and CM operational excellence and accountability internally and with the CRM and CM key suppliers <li> <li> Oversees all operational aspects including key suppliervendor relationships database management digital operations reporting management of technology infrastructure and capability solutions developing a roadmap for identifying and integrating solutions to leverage emerging channels compliance and information integrity governance streamlining and standardizing operating processes <li> <li> Demonstrates strength and expertise on Medical Information CRM CM and operations to ensure we optimize our vendor partners capitalize on existing database functionality and ensure that our infrastructure can support our currentfuture needs <li> <li> Identifies opportunities to enhance projects and initiatives resulting in recommendations to improve processes and optimizing future endeavors <li> <li> Responsible for overseeing financial management of all activities within the responsibilities of the role Participates in and drives financial planning opportunities as part of budget review <li> <li> Responsible for managing inhouse digital specialist contingent staff andor offshored team members <li> <li> Identifies key metrics and evaluates ROIimpact of digital and automation initiatives <li> <li> Supports MI Content synchronization <li> <li> Partners with NNI IT to ensure Novo Nordisk develops the technical requirements that support execution of current and future digital initiatives including identification and integration of emerging channels and solutions <li> <li> Stays abreast of technical knowledge medical communication digital tools and Medical Information industry trends <li> <ul><p><br ><b>Physical Requirements<b> <br >010 overnight travel required <br ><b>Development of People<b> <br >Ensure that reporting personnel have individual development plans IDP with annual goals and measurements that are consistent with the priorities of the business and that interim reviews are held so that their work is focused on those priorities and they understand their level of accountability for results and the measurement process <br >Ensure that the IDP forms include completed learning and aspiration plans and are in place for all reporting personnel to enable the achievement of goals and capability to assume increased levels of responsibility <br >Manage the application and communication of all Novo Nordisk policies procedures and Novo Nordisk Way <br ><b>Qualifications<b> <br ><p><ul><li> A Bachelors degree required with a minimum of 10 years of relevant experience ideally a technical degreeie ITISSoftware EngineeringComputer Science Healthcare degree preferred with 6 years of relevant experience <li> <li> A minimum of 1 year of pharmaceutical industry experience required 3 years of medical affairs or medical information experience preferred <li> <li> A minimum of 1 year of experience developing and executing digital initiatives required <li> <li> Excellent collaboration skills required to coordinate activities with internal and external stakeholders <li> <li> Experience in designing and executing communication plans for successful launches of digitaltechnology initiatives required <li> <li> Ability to develop strategic plans and operationalize into executable tactics <li> <li> Demonstrates project management skills and leadership for new and existing system enhancements <li> <li> Experience in medical information systems preferred such as Medical Information Customer Relationship Management CRM system Content Management CM system telephony systems etc <li> <li> Must be able to execute short term results while developing capabilities for future requirements <li> <li> Strong technical background with working knowledge of database design digital and cloud systems and emerging opportunities like mobile and social media <li> <li> Strong analytical problemsolving skills with highly customeroriented application support required <li> <li> Strong communication skills required <li> <li> People management experience preferred <li> <ul><p><br >We commit to an inclusive recruitment process and equality of opportunity for all our job applicants <br >At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives backgrounds and cultures We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees the patients we serve and communities we operate in Together were life changing <br >Novo Nordisk is an equal opportunity employer Qualified applicants will receive consideration for employment without regard to race ethnicity color religion sex gender identity sexual orientation national origin disability protected veteran status or any other characteristic protected by local state or federal laws rules or regulations <br >If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply please call us at 18554115290 This contact is for accommodation requests only and cannot be used to inquire about the status of applications<p>
Senior Manager - Strategic Pricing and Contracting Advisory
Company: Novo Nordisk
Location: Other US Location
Posted Mar 10, 2024
<p><b>About the Department <b> <br >At Novo Nordisk our Finance and Operations team is the engine that elevates holistic commercialization of our products The Finance and Operations team works closely with the business across the organization to guide enterprise wide resource allocations investment choices drive core operations and develop insights to drive growth and operational excellence across the value chain while innovating for future capabilities We regulate accounting uphold workplace safety manage our supply chain and sampling support technology provide commercial operations insights amp analytics maintain our facilities and assure the integrity and completeness of all business transactions At Novo Nordisk you will have the opportunity to build a lifechanging career in a global business environment We encourage our employees to make the most of their talent And we reward hard work and dedication with the opportunity for continuous learning and personal development Are you ready to realize your potential <br ><b>The Position<b> <br >The Strategic Pricing and Contracting SPC Advisory is a Center of Excellence for Scenario Planning and Modeling The Advisory is led by a Director and structured to act as a hub bringing together crossfunctional teams such as Strategy and Innovation Mature Business Unit Market Access Account Directors and SPC Account Leads The increased consolidation and complexity of GPOPBMs have created a need for additional resources to ensure our strategy is on course for national formularies and their downstream clients This individual will be responsible for supporting and optimizing approved strategies across Commercial and Medicare channels and customers with the designated SPC Account Lead as well as identifying current market trends or signals that may call for reevaluation of our strategic direction <br ><b>Relationships<b> <br >The position reports to the Director Strategic Pricing and Contracting Advisory The individual will partner and work closely with a number of internal and external functions within Novo Nordisk Inc NNI including Brand Teams VP PCOR Director Pricing and Market Access Insights Sr Director Strategic Pricing and Contracting Government Pricing Team Market Access VP Directors and Account Executives Pricing Committee and to a lesser degree Forecasting Health Economics FPampA Legal Commercial Insights and Analytics <br ><b>Essential Functions<b> <br ><p><ul><li> Advisory Acts as a Center of Excellence for Scenario Planning and Modeling provides continuous feedback loop to Strategy and Innovation National Account Teams and others Pricing Committee Brand Marketing etc <li> <li> Ensures approved pricing and contracting strategies are executed and optimized across customers in the channel and for national formularies and downstream clients <li> <li> Supports collaboration meetings with Strategy team where SPC and SampI align on requests for information scenario modelling and other ad hoc analysis <li> <li> Collaborates closely with SPC Leadership Team to provide additional insights and guidance from the Advisory Scenario Planning acts as backup to Director Strategic Pricing and Contracting Advisory <li> <li> Enables SPC reporting of contracted price concessions <li> <li> Supports maintaining and updating NAO Pricing and Contracting SOPs <li> <li> Builds trusting collaborative relationships and alliances with others inside and outside of the organization <li> <li> Demonstrates knowledge of internal business operations and applies this knowledge to analyses processes and deliverables <li> <li> Manages the development and implementation deal evaluation process to quantify the profitability of newexisting contracts for inline products <li> <li> Structures all offers with respect to the development of financial analytics and profitability metrics <li> <li> Supports preparation of all Pricing Committee business cases and financial analyses related to Scenario Planning <li> <li> Facilitates the deal evaluation process to support implementation of Market Access Strategy and Innovation <li> <li> Participates in prePricing Committee meetings and leads the review of financial impact scenarios as necessary <li> <li> Analyzes the impact on pricing decisions on ARPprofitability <li> <li> Ensures all Terms amp Conditions align with anticipated deal structure to support strategy and identified scenarios <li> <li> Partners and works closely with the Director Strategic Pricing and Contracting Strategy Directors and Account DirectorsExecutives to finalize all proposals for key stakeholders <li> <li> Provides regular updates for Brand Teams and Senior Management on contract performance issues including over and underperforming contracts <li> <li> Responsible for staying current on pricing regulatory guidelines market trends and competitive activity and provides information to internal customers including Brand Teams Market Access Strategy and Innovation and Senior Management <li> <li> Understands competitive dynamics to identify key opportunities and threats and incorporates into strategies and plans <li> <li> Works closely with Strategy Directors to ensure all offers align with all aspects of approved strategies <li> <li> Autonomously authors complex contract documents based on approved products and pricing market baskets and product positioning requirements Independently works with customers and internal functional areas to reach agreement on business and legal aspects of a contract Provides such documents to the account executive andor customer within the required time frame <li> <li> Obtains all appropriate and required internal reviews and approvals for contract terms and provisions Ensures accuracy of pricing market baskets and terms within appropriate documents and timely submission of contracts to customers following offer approvals <li> <li> Consistently follows company policies and procedures to ensure compliance with all guidelines Sarbanes Oxley compliance regulations and policies <li> <li> Advises leadership and stakeholder functional areas of contractual rights obligations and risk analysis as necessary <li> <li> Supports business and analytical expertise in the development of tools and methods that will result in more accurate customer profitability assessment and decisionmaking <li> <li> Identifies opportunities and makes recommendations for optimal performance processes and compliance improvement across entire contract management continuum <li> <li> Leads with excellent communication and interpersonal skills and demonstrates effectiveness at working effectively with stakeholders <li> <ul><p><br ><b>Physical Requirements<b> <br >010 overnight travel required <br ><b>Qualifications<b> <br ><p><ul><li> A Bachelors Degree required degree in Business preferred Advanced degree preferred preferably an MBA Legal experience a plus <li> <li> A minimum of eight 8 years experience with a minimum of four 4 years of progressively responsible experience in the areas of pricing contracting forecasting andor portfolio analysis required pharmaceutical experience preferred Advanced degree may be substituted for experience when appropriate <li> <li> A strong level of analytical quantitative and qualitative analysis skills <li> <li> Advanced proficiency in Microsoft Excel Access PowerPoint Word and other key platforms <li> <li> Ability to deliver message and presentations in a clear confident manner <li> <li> Ability to interact and manage multiple internal relationships at all levels of the business <li> <li> Demonstrated leadership skills <li> <li> Demonstrates an ability to manage and influence to ensure business objectives are met <li> <li> Excellent communication and negotiation skills <li> <ul><p><br >We commit to an inclusive recruitment process and equality of opportunity for all our job applicants <br >At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives backgrounds and cultures We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees the patients we serve and communities we operate in Together were life changing <br >Novo Nordisk is an equal opportunity employer Qualified applicants will receive consideration for employment without regard to race ethnicity color religion sex gender identity sexual orientation national origin disability protected veteran status or any other characteristic protected by local state or federal laws rules or regulations <br >If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply please call us at 18554115290 This contact is for accommodation requests only and cannot be used to inquire about the status of applications<p>
Maintenance Scheduler I
Company: Novo Nordisk
Location: Other US Location
Posted Mar 12, 2024
<p><b>About the Department <b> <br >Site New Hampshire located in West Lebanon is where Novo Nordisks lifesaving treatments are brought to life Our manufacturing facility produces a global supply of our hemophilia and growth hormone product lines as well as our next generation of cuttingedge medications <br >What we offer you <br ><p><ul><li> Leading pay and annual performance bonus for all positions <li> <li> 34 Paid days off including vacation sick days amp company holidays <li> <li> Health Insurance Dental Insurance Vision Insurance <li> <li> Guaranteed 8 401K contribution plus individual company match option <li> <li> 12 weeks Paid Parental Leave <li> <li> Free access to Novo Nordiskmarketed pharmaceutical products <li> <ul><p><br >At Novo Nordisk you will find opportunities resources and mentorship to grow and build your career Are you ready to realize your potential <br ><b>The Position<b> <br >The primary focus of this role is to interface between maintenance manufacturing and production scheduling to schedule planned maintenance tasks and ensure completion of work and follow on activities The role also provides support to the administration of the Computerized Maintenance Management System CMMS and other Facilities related administrative systems as directed <br ><b>Relationships<b> <br >Reports to According to the organizational chart <br ><b>Essential Functions<b> <br ><p><ul><li> Responsible for scheduling and coordination of maintenance activities <li> <li> Develop and maintain key performance indicators to track adherence to schedule Report on these metrics routinely <li> <li> Create and manage the weekly and monthly schedule of work to be performed by Facilities on Manufacturing equipment <li> <li> Work with Manufacturing Scheduling to ensure impactful maintenance tasks are identified on production schedule <li> <li> Develops system administrator skills for the CMMS <li> <li> Primary daily interface with the Facilities and Manufacturing teams to schedule confirm completion of maintenance work and verify follow up activities are completed <li> <li> Generate or facilitate as needed document revisions related to maintenance Facilities or Quality systems <li> <li> Facilitate planning scheduling and issue resolution forums as directed by the supervisor <li> <li> Coordinate and support training of site staff related to CMMS and maintenance scheduling as directed <li> <li> Support resolution of quality system items exceptions deviations and CAPA as requested <li> <li> Must be selfdriven and able to prioritize problemsolve and trouble shoot in a fast paced complex environment <li> <li> Communicate effectively with all internal and external customers Must have a collaborative teamcustomer focus <li> <li> Other duties as required by supervisor These may include but are not limited to training coordinator metrology program support and turn over package administration <li> <li> Performs all job duties and responsibilities in a compliant and ethical manner and in accordance with all applicable healthcare laws regulations and industry codes <li> <li> Incorporates the Novo Nordisk Way and 10 Essentials in all activities and interactions with others <li> <ul><p><br ><b>Physical Requirements<b> <br >010 overnight travel required The ability to climb reach stand and walk The ability to push pull lift finger feel and grasp The ability to speak listen and understand verbal and written communication Repetition including substantial movement of wrists hands and or fingers Lifting up to 10 of force occasionally Sedentary work walking and standing are required only occasionally Visual acuity to perform close activities such as reading writing and analyzing and to determine the accuracy neatness and thoroughness of work assigned or to make general observations <br ><b>Qualifications<b> <br ><p><ul><li> Education and Certifications <ul><li> AAASAAS or Bachelors degree in related field or equivalent industrial military or vocational training <li> <ul><li> <li> Work Experience <ul><li> Minimum of three 3 years of maintenance experience pharmaceutical industry preferred or minimum of one 1 year of maintenance scheduling or production scheduling <li> <li> Experience working with a CMMS Regulatory Asset Manager preferred Procore Bluebeam or similar systems <li> <ul><li> <ul><ul><li> Knowledge Skills and Abilities <ul><li> Adept at understanding anticipating and addressing prerequisite and interdependent tasks to complete all activities as scheduled <li> <li> Strong interpersonal and team skills including conflict resolution <li> <li> Strong computer skills to Microsoft applications Excel PowerPoint Word and the ability to quickly learn other systems and applications <li> <ul><li> <ul><p><br >We commit to an inclusive recruitment process and equality of opportunity for all our job applicants <br >At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives backgrounds and cultures We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees the patients we serve and communities we operate in Together were life changing <br >Novo Nordisk is an equal opportunity employer Qualified applicants will receive consideration for employment without regard to race ethnicity color religion sex gender identity sexual orientation national origin disability protected veteran status or any other characteristic protected by local state or federal laws rules or regulations <br >If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply please call us at 18554115290 This contact is for accommodation requests only and cannot be used to inquire about the status of applications<p>
Associate Director - Biostatistics
Company: Novo Nordisk
Location: Boston, MA
Posted Mar 13, 2024
<p><b>About the Department <b> <br >At Novo Nordisk Research Center Seattle Inc NNRCSI our scientists apply cuttingedge technologies to early RampD projects with the goal of bringing real change to people with Diabetes and Obesity Our scientists apply stateoftheart technologies within the diabetes and obesity areas with the goal of bringing molecules to market Your skills dedication and ambition will help change lives for the better and you will work with extraordinary talent continuously learn and develop and drive changes to defeat serious chronic conditions We recognize the importance of an enjoyable workplace which stimulates a strong culture of ingenuity and innovation and our support of a healthy worklife balance adds to a bestinclass employee experience The team is comprised of collaborative diverse and passionate people who have a true sense of pride in their work and are committed to helping others grow and develop in their careers Youll also have a platform to engage with key stakeholders on a global scale throughout the entire pipeline process And while changing the future of obesity treatment is no easy task we also recognize the importance of an enjoyable workplace which is why weve cultivated a culture of fun ingenuity and innovation We are changing lives are you ready to make a difference <br ><b>The Position<b> <br >Key responsibilities for Associate Director of Biostatistics are Driving the statistical strategy of the designated projects taking into consideration the impact across Development Responsible for shaping and driving the statistical content and quality of deliverables for submissions and authority interactions Responsible for ensuring consistency and relevant standardization within the designated projects on statistical activities based on a thorough analysis and interpretation of internal and external factors Being a role model as statistical expert serving as mentor and inspiration for the team <br ><b>Relationships<b> <br >This position will report to the Executive Director of Biostatistics and Programming <br ><b>Essential Functions<b> <br ><p><ul><li> Driving the statistical strategy of the designated projects taking into consideration the impact across Development <ul><li> Instrumental in planning the development of a drug designing clinical trials and interpreting the results of the clinical trials carried out in the project <li> <li> Provide key input to post approval marketing communication <li> <li> Lead project teams to achieve milestones and objectives <li> <li> Prioritize plan manage and execute clinical trials and submissions within project area <li> <li> Proactively looks for opportunities where new methodology and processes could save costs and time and increase quality <li> <li> Acts independently as consultant on statistical aspects in complex and highprofile problems <li> <li> Drives knowledge sharing also across project areas <li> <ul><li> <li> Responsible for shaping and driving the statistical content and quality of deliverables for submissions and authority interactions <ul><li> Presentation and negotiation of clinical development program at meetings with regulatory authorities first submission incl FDA AdCom meetings <li> <li> Ensure the right quality level of statistical deliverables for regulatory documents and interactions eg summary documents QampA AdComm etc considering risk willingness <li> <li> Represents Novo Nordisk regarding statistics in meetings and inspections with regulatory authorities <li> <ul><li> <ul><ul><li> Responsible for ensuring consistency and relevant standardisation within the designated projects on statistical activities based on a thorough analysis and interpretation of internal and external factors <ul><li> Ensure development of standards on the project eg Project ADRG and statistical methodologies <li> <li> Develops and makes available the best statistical methods and techniques <li> <li> Challenge status quo and seek out new innovative tools or ways of working to simplify processes and enhance Biostatistics impact <li> <li> Further expand competences and knowhow within statistics <li> <ul><li> <li> Being a role model as statistical expert serving as mentor and inspiration for the team <ul><li> Inspire and motivate team and ensure excellent deliverables by self and team <li> <li> Act as a resource for colleagues with less experience eg by training and mentoring staff within the project <li> <li> Perceived as an expert within key Biostatistics processes and must ensure to keep specialist knowledge up to date <li> <ul><li> <ul><p><br ><b>Physical Requirements<b> <br >UP to 10 overnight travel required <br ><b>Qualifications<b> <br ><p><ul><li> Masters degree in Statistics or Biostatistics with 7+ years of experience or PhD with 5+ years of experience <ul><li> Experience as a statistician within the pharmaceutical industry or equivalent required <li> <ul><li> <li> Expert knowledge of biostatistical methods <li> <li> Extensive and broad experience with practical applications of biostatistical methodology <li> <li> Knowledge specialist of drug development <li> <li> Broad experience with statistical software and IT and indepth experience with at least one statistical software package <li> <li> Indepth knowledge of GCP and statistical guidelines within drug development <li> <li> Extensive experience with communication and presentation of statistical issues <li> <li> Elevated business insight to proactively deliver required results of key value to stakeholders with a focus on how stakeholders depend on the deliverables <li> <li> Regular participation in medical and statistical conferences workshops <li> <li> Experience with supervision and mentoring of staff <li> <li> Experience with the process of drug applications with the FDA PMDA and EMA <li> <li> Extensive experience with collaboration across professional and regional borders <li> <li> Consultancy experience within a broad area of clinical andor nonclinical RampD <li> <li> Record of presentations publications <li> <li> Interaction with external contacts in the pharmaceutical industry and in academia <li> <ul><p><br >We commit to an inclusive recruitment process and equality of opportunity for all our job applicants <br >At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives backgrounds and cultures We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees the patients we serve and communities we operate in Together were life changing <br >Novo Nordisk is an equal opportunity employer Qualified applicants will receive consideration for employment without regard to race ethnicity color religion sex gender identity sexual orientation national origin disability protected veteran status or any other characteristic protected by local state or federal laws rules or regulations <br >If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply please call us at 18554115290 This contact is for accommodation requests only and cannot be used to inquire about the status of applications<p>
Automation Engineer II - Site Capacity (Multiple Openings)
Company: Novo Nordisk
Location: Raleigh-Durham, NC
Posted Mar 09, 2024
Novo Nordisk, a global leader in diabetes care for over a century, offers life-changing careers with competitive pay, comprehensive benefits, and opportunities for career growth. The company operates three pharmaceutical manufacturing facilities in North Carolina, including the Injectable Finished Products (IFP) facility in Clayton, responsible for producing innovative diabetes and obesity treatments. The role involves ensuring new processes and equipment are compliant with global standards, improving process control systems, and supporting various initiatives and projects. Required qualifications include a BA/BS in engineering or related field and at least five years of engineering experience in process-based manufacturing. Desired qualifications include knowledge in PLC, SCADA, MES, Oracle, and MS SQL.
Senior Scientist - Global Drug Discovery
Company: Novo Nordisk
Location: Boston, MA
Posted Mar 10, 2024
<p><b>About the Department<b> <br >Our Boston Research amp Development hub anchored in the greater Boston area brings together the best minds in life science innovation The teams located in facilities in Lexington Watertown and Cambridge reflect the full RampD continuum from early research through latestage clinical development Here we are building for the future creating a distinct RampD community based on collaboration partnerships and cuttingedge research across multiple modalities and therapeutic areas We recognize that improving human health starts here and that patients rely on us Our greater Boston RampD hub merges biotech speed and agility with large pharmaceutical company quality resources and stability uniting the best of both worlds to develop new medicines for patients<br >The team is comprised of collaborative diverse and passionate people who have a true sense of pride in their work and are committed to helping others grow and develop their careers Youll also have a platform to engage with key stakeholders on a global scale throughout the entire pipeline process And while changing the future of diabetes and obesity treatment is no easy task we also recognize the importance of an enjoyable workplace which is why weve cultivated a culture of fun ingenuity and innovation And our competitive compensation package and support of a healthy worklife balance all add to a bestinclass employee experience We are changing lives for a living Are you ready to make a difference<br ><b>The Position<b> <br >The Target Discovery Engine TDE is a global multidisciplinary team that focuses on accelerating the path of target discovery and validation at Novo Nordisk Scientists in the TDE take a humancentric approach to drug discovery utilizing cuttingedge approaches to model human disease combined with advanced techniques in functional genomics and machine learning to identify and characterize novel targets By doing so the TDE team aims to redefine how the industry approaches target discovery with the ambition of accelerating the drug discovery process through unlocking a deeper understanding of disease and treatment outcomes<br >The Senior Scientist Discovery Biology TDE Boston will be responsible for developing and implementing innovative research strategies and technologies to model human cardiometabolic disease in vitro and leverage these systems for novel target<br ><b>Relationships<b><br >Reports to the Director Discovery Biology TDE US The person in this role will interact closely with TDE scientists in Boston Oxford and Beijing and collaborate with global Therapy Area and Biology Innovation teams to ensure efficient delivery of target discovery and validation efforts Additional internal relationships include working with research employees project managers as well as with global colleagues in other areas across Novo Nordisk Inc This position may mentor or indirectly supervise junior scientists and research associates External relationships include those with contract research organizations key opinion leaders innovative academic and biotech partners<br ><b>Essential Functions<b> <br ><p><ul><li>Development and application of iPSC derived models of human cardiometabolic disease to support TDE strategy in obesity target discovery and validation and accelerate advancement of new drug targets into the NN pipeline<li> <li>Drive innovative research strategies to deliver scalable human and diseaserelevant cells and assays and generate highquality translatable in vitro data for obesity drug discovery<li> <li>Function as subject matter expert for pluripotent stem cell biology cell line development and engineering and lead crossfunctional global projects and teams to support TDE goals<li> <li>Develop and communicate a vision and engage people in that vision<li> <li>Establish and manage project goals timelines and deliverables for efficient gonogo decisions<li> <li>Mentor and coach team members to help achieve the project goals<li> <li>Communicate strategies progress and challenges across the organization and to leadership<li> <li>Promote relevant crossorganizational collaborations and ensure efficient transfer and knowledge sharing with key stakeholders and customers across global sites including China UK and Europe<li> <li>Build and maintain strong relationships and collaborations with external researchers<li> <li>Establish relevant external collaborations with academia to facilitate constant development of core technologies<li> <li>Develop and manage CRO relationships in support of research goals<li> <ul><p><br ><b>Qualifications<b><br ><p><ul><li>PhD in Biological Sciences andor Stem cell biology or related degree with a minimum of 6 years relevant work experience industry preferred MS with 12 years or BABS with 18 years work experience may be considered<li> <li>6 or more years drug discovery experience in a biotechnology or biopharmaceutical setting strongly preferred<li> <li>Extensive experience with inducedpluripotent stem cell iPSC technology for cell model development characterization and quality control across multiple differentiated cell types<li> <li>Expertise in molecular biology advanced cell engineering techniques and functional genomics assay platforms<li> <li>Experience with fluorescence microscopy highcontent imaging and cellular functional assay technologies<li> <li>Familiarity with application of in vitro cell models and assays for highthroughput in vitro screens<li> <li>Knowledge of metabolic biology relevant to obesity diabetes and other cardiometabolicrelated disorders<li> <li>Demonstrated track record of scientific leadership and delivery on early discovery projects<li> <li>Experience building and maintaining productive internal relationships across complex research organizations and the ability to effectively represent Novo Nordisk in external settings<li> <li>Experience in development and ownership of shared resources<li> <li>Excellent written and oral communication skills<li> <ul><p><br >We commit to an inclusive recruitment process and equality of opportunity for all our job applicants <br >At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives backgrounds and cultures We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees the patients we serve and communities we operate in Together were life changing <br >Novo Nordisk is an equal opportunity employer Qualified applicants will receive consideration for employment without regard to race ethnicity color religion sex gender identity sexual orientation national origin disability protected veteran status or any other characteristic protected by local state or federal laws rules or regulations <br >If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply please call us at 18554115290 This contact is for accommodation requests only and cannot be used to inquire about the status of applications<p>
Supervisor, Metrology - FFEx (Nights)
Company: Novo Nordisk
Location: Raleigh-Durham, NC
Posted Mar 10, 2024
<p><b>About the Department <b> <br >At Novo Nordisk we want to make a difference For more than 100 years we have led the way in diabetes care Being part of Novo Nordisk allows our employees to embark on lifechanging careers and the opportunity to help improve the quality of life for millions of people around the world <br >In NC we operate three pharmaceutical manufacturing facilities that are responsible for fulfilling different steps in our injectable and oral treatment supply chains Our legacy Injectable Finished Products IFP facility in Clayton NC is a 457000 square foot aseptic fill and finish site that is responsible for producing innovative injectable diabetes and obesity treatments At IFP youll join a global network of manufacturing professionals who are passionate about what they do <br >What we offer you <br ><p><ul><li> Leading pay and annual performance bonus for all positions <li> <li> All employees enjoy generous paid time off including <b>14 paid holidays<b> <li> <li> Health Insurance Dental Insurance Vision Insurance effective day one <li> <li> Guaranteed 8 401K contribution plus individual company match option <li> <li> Family Focused Benefits including 12 weeks paid parental amp 6 weeks paid family medical leave <li> <li> Free access to Novo Nordiskmarketed pharmaceutical products <li> <li> Tuition Assistance <li> <li> Life amp Disability Insurance <li> <li> Employee Referral Awards <li> <ul><p><br >At Novo Nordisk you will find opportunities resources and mentorship to help grow and build your career Are you ready to realize your potential Join Team Novo Nordisk and help us make what matters <br ><b>The Position<b> <br >Oversee the performance of all metrology calibration activities metrology work requests and related projects to ensure compliance with applicable procedures policies and cGMPs Assist with preparation of yearly Metrology budget audit and approval of contract Metrology services performance reviews and emergency scheduling <br ><b>Relationships<b> <br >Reports to the Manager Metrology <br ><b>Essential Functions<b> <br ><p><ul><li> Provide direction coaching mentoring assistance to direct reports in order to meet andor exceed customer requirements ensuring a high performing collaborative team environment while providing continuous feedback structure and accountability to improve team performance <li> <li> Perform testing and calibration of production equipment and measurement standards across multiple measurement disciplines in accordance with Standard Operating Procedures <li> <li> Maintain documentation and RAM SAP database pertaining to calibration activities <li> <li> Lead SPS activities concerning instrumentation with process equipment and utilities <li> <li> Drive metrology performance to meet business customer and quality needs through worldclass metrology practices <li> <li> Ensure metrology practices are standardized throughout department <li> <li> Ensure that unscheduled events are completed in accordance with current SOPs policies and guidelines to support site business objectives and goals <li> <li> Ensure training requirements are uptodate and training is maintained for all members of the metrology team <li> <li> Provide input to regulatory officials andor provide documentation needed during inspections <li> <li> Maintain metrology documentation compliance with current regulatory guidelines <li> <li> Support and participate in site shutdown activities and planning to include daily board meetings direct communications with the shutdown manager and coordination with metrology technicians <li> <li> Identify continuous improvement opportunities and implement them in order to maintain and improve metrology program <li> <li> Create develop define and implement dynamic key performance indicators KPIs for areas of responsibility <li> <li> Follow all safety amp environmental requirements in the performance of duties <li> <li> Other accountabilities as assigned <li> <ul><p><br ><b>Physical Requirements<b> <br >Ability to work in an open office environment with the possibility of frequent distraction Ability to travel up to 10 of the time <br ><b>Development of People<b> <br >Ensure that reporting personnel have individual development plans IDP with annual goals and measurements that are consistent with the priorities of the business and that interim reviews are held so that their work is focused on those priorities and they understand their level of accountability for results and the measurement process <br >Ensure that the IDP forms include completed learning and aspiration plans and are in place for all reporting personnel to enable the achievement of goals and capability to assume increased levels of responsibility <br >Manage the application and communication of all Novo Nordisk policies procedures and Novo Nordisk Way <br ><b>Qualifications<b> <br ><p><ul><li> Bachelors degree in relevant field from an accredited university required or equivalent combination of education and experience <li> <li> May consider an Associates degree or equivalent with a minimum of seven 7 years of experience with calibration troubleshooting and electronics repair experience within a processbased manufacturing environment required preferably within a pharmaceutical manufacturing environment <li> <li> May consider a High School Diploma or equivalent with a minimum of seven 9 years of experience with calibration troubleshooting and electronics repair experience within a processbased manufacturing environment required preferably within a pharmaceutical manufacturing environment <li> <li> Minimum of five 5 years of experience with calibration troubleshooting and electronics repair experience within a processbased manufacturing environment required preferably within a pharmaceutical manufacturing environment <li> <li> Minimum of two 2 years of direct supervisory experience preferred <li> <li> Experience working within a cGMP environment preferred <li> <li> Strong working technical and operational knowledge of calibration of measuring equipment preferred <li> <li> Computer literate required <li> <li> Proven Team player preferred <li> <li> Previous experience in clean room and cGMP applications required <li> <li> Strong communication skills required <li> <li> Coaching and mentoring of direct reports preferred <li> <ul><p><br >We commit to an inclusive recruitment process and equality of opportunity for all our job applicants <br >At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives backgrounds and cultures We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees the patients we serve and communities we operate in Together were life changing <br >Novo Nordisk is an equal opportunity employer Qualified applicants will receive consideration for employment without regard to race ethnicity color religion sex gender identity sexual orientation national origin disability protected veteran status or any other characteristic protected by local state or federal laws rules or regulations <br >If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply please call us at 18554115290 This contact is for accommodation requests only and cannot be used to inquire about the status of applications<p>
Quality Assurance Area Specialist II - OFP 2nd Shift ( Release Focus)
Company: Novo Nordisk
Location: Raleigh-Durham, NC
Posted Mar 10, 2024
<p><b>About the Department<b> <br >For more than 100 years Novo Nordisk has been tackling the unmet medical needs of people living with serious chronic diseases such as diabetes amp obesity Being part of Novo Nordisk allows our employees to embark on lifechanging careers and the opportunity to help improve the quality of life for millions of people around the world <br >In NC we operate three pharmaceutical manufacturing facilities that are responsible for fulfilling different steps in our injectable and oral treatment supply chains Our Emerging Technologies Oral Finished Products facility in Durham NC is a 194000 square foot tableting and packaging facility that supports the production of our innovative oral treatments for patients with type 2 diabetes OFP maintains a curious and pioneering spirit harmonious with our growing pipeline of new products and emerging technologies <br >What we offer you <br ><p><ul><li> Leading pay and annual performance bonus for all positions <li> <li> All employees enjoy generous paid time off including <b>14 paid holidays<b> <li> <li> Health Insurance Dental Insurance Vision Insurance effective day one <li> <li> Guaranteed 8 401K contribution plus individual company match option <li> <li> Family Focused Benefits including 12 weeks paid parental amp 6 weeks paid family medical leave <li> <li> Free access to Novo Nordiskmarketed pharmaceutical products <li> <li> Tuition Assistance <li> <li> Life amp Disability Insurance <li> <li> Employee Referral Awards <li> <ul><p><br >At Novo Nordisk you will find opportunities resources and mentorship to help grow and build your career Are you ready to realize your potential Join Team Novo Nordisk and help us make what matters <br ><b>The Position<b> <br >Performs quality review amp approval of Batch Production Records BPRs Change Requests CRs Deviations amp other documentation in conjunction with LoB amp QA presence amp process confirmation on shop floor Handles release of raw materials amp provides quality oversight review amp approval of validation activities associated with minor changes to existing systems Performs archiving duties amp QA presence amp process confirmation on shop floor <br ><b>Relationships<b> <br >Manager Quality Assurance <br ><b>Essential Functions<b> <br ><p><ul><li> Ensures site compliance with Regulations ISO standards corporate amp local SOPs <li> <li> Reviews amp approves documentation for Quality approval componentsraw material batch records change control requests deviations amp validation documents <li> <li> Performs QA presence amp process confirmation on shop floor <li> <li> Participates in project teams as a quality resource <li> <li> Supports reviews amp approves investigations amp rootcause analysis <li> <li> Participates in process confirmations amp Go Look Sees <li> <li> Evaluates trend amp report data for QMRs amp APR reports <li> <li> Other accountabilities as assigned <li> <ul><p><br ><b>Physical Requirements<b> <br >Occasionally moves equipment ampor supplies weighing up to 33 pounds Ability to work in an open office environment with the possibility of frequent distraction Ability to work the hours necessary to support a 247 continuous manufacturing operation Ability to adjust schedule to work with colleagues in other international time zones Some roles require ability to work 12hour shifts or longer day or night Ability to travel domestically ampor internationally as necessary <br ><b>Qualifications<b> <br ><p><ul><li> Bachelors degree in life sciences or related field of study from an accredited university required <li> <li> With PampO reviewagreement equivalent combination of education amp internal NN businessoperational experience may be substituted for degree as appropriate <li> <li> Minimum of three 3 years of QA ampor quality related experience required preferably in the pharmaceutical or medical device industry <li> <li> Understanding of cGMP manufacturing amp production processes amp how to apply required <li> <li> Understanding of the Batch Review Processes required <li> <li> Understanding of validation preferred <li> <li> Understanding of quality management systems required <li> <li> Understanding of quality oversight amp on floor production support required <li> <li> Knowledge in Quality Management Systems <li> <li> Demonstrated knowledge of critical controls amp inputoutput requirements for NNPILP processes preferred <li> <li> Excellent written amp verbal communication skills required <li> <li> Basic computer skills in MS Office MS Project PowerPoint etc required <li> <li> Auditing experience with certification a plus <li> <li> Experience in the use of Six Sigma amp LEAN tools a plus <li> <li> Personal Time Management Sets goals amp prioritizes tasks for own work on shortterm basis <li> <li> Meets deadlines amp makes regular progress reports on performance <li> <li> Keeps track amp informs management about fluctuation in workload <li> <li> Performs well with multitasking Adjust priorities in accordance with changing circumstances <li> <li> Keeps all relevant people informed of current amp future plans <li> <ul><p><br >We commit to an inclusive recruitment process and equality of opportunity for all our job applicants <br >At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives backgrounds and cultures We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees the patients we serve and communities we operate in Together were life changing <br >Novo Nordisk is an equal opportunity employer Qualified applicants will receive consideration for employment without regard to race ethnicity color religion sex gender identity sexual orientation national origin disability protected veteran status or any other characteristic protected by local state or federal laws rules or regulations <br >If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply please call us at 18554115290 This contact is for accommodation requests only and cannot be used to inquire about the status of applications<p>
Manager, MES Engineering, PAS - X
Company: Novo Nordisk
Location: Raleigh-Durham, NC
Posted Mar 10, 2024
Novo Nordisk, a global leader in diabetes care for over a century, offers life-changing careers with competitive pay, comprehensive benefits, and opportunities for career growth. The Manufacturing Execution Systems (MES) department, divided into system support and system management, provides leadership and coaching to MES staff. Responsibilities include developing strategic goals, driving improvement projects, and ensuring MES systems meet production and business requirements. The role requires a Bachelor's degree in Engineering or a relevant field, 7+ years of MES experience, and people leadership skills. Novo Nordisk is committed to diversity and inclusion, fostering an environment that celebrates the diversity of its employees, patients, and communities.
Manager - Regulatory Affairs - Therapeutic Area
Company: Novo Nordisk
Location: Other US Location
Posted Mar 10, 2024
<p><b>About the Department <b> <br >The Clinical Medical and Regulatory CMR department at Novo Nordisk is one of the most diverse and collaborative groups within the organization From healthcareprovider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and new product development CMR is involved The one thing that keeps us all marching to the same beat is our patientcentered focus At Novo Nordisk you will help patients around the world As their needs evolve so does our challenge to find better and more innovative ways to improve their quality of life Were changing lives for a living Are you ready to make a difference <br ><b>The Position<b> <br >Manage and oversee all assigned projectsproductsprocesses Assist the DirectorAssociate Director in assuring Novo Nordisk compliance with internal SOPs and Federal and State regulations including compilation and submission of any required documents to regulatory agencies Supervise designated personnel <br ><b>Relationships<b> <br >Report to the DirectorAssociate DirectorLead Regulatory ScientistSr Manager Regulatory Affairs Develop and maintain positive rapport and working relationships with other personnel in Regulatory Affairs CMR and other local and headquarter departments to accomplish company goals External relationships may include interaction with FDA personnel regarding assigned projects and roles <br ><b>Essential Functions<b> <br ><p><ul><li> Compile and submit responses to FDA communications MANAGER THERAPEUTIC AREA Compile submit and maintain applications IND NDA Biologics Devices to government agencies in support of research and marketed products <li> <li> Create and maintain productproject database to record history of questions asked responses received during FDA meetings <li> <li> Liaison between Novo Nordisk Inc NNI and NNAS departments for preparation of documentation necessary for submission of applications <li> <li> Maintain meeting documentation templates and ensure they are current with FDA guidances and Novo Nordisk standards <li> <li> Maintain uptodate knowledge of laws regulations and policies enforced by the Federal and State governments as they relate to pharmaceuticals and devices <li> <li> Maintain uptodate knowledge of the data information and formats required for inclusion in these applications <li> <li> Manages simple development projects or portions of projects <li> <li> May act as FDA liaison for routine contacts and handles finalization of routine correspondence <li> <li> May act as GRT member <li> <li> Oversight of annual reports <li> <li> Participate in project team meetings as assigned <li> <li> Review data from contributing departments including NNAS and provide comments to assure accurate and complete documents for inclusion in these applications <li> <li> Review of regulatory strategy documents eg provides supervisor with input on regulatory strategy documents <li> <li> Supervise review and approval of labeling for marketed products <li> <li> Track applications through FDA reviewing divisions <li> <li> Work with project associate on compilation of information and supportive documentation for FDA briefing packages <li> <li> Work with project leader and team to draft FDA meeting requests and supporting briefing packages for FDA meetings preIND EOP 2 preNDA preBLA for review by Project Leaders <li> <li> Write Regulatory documents translating team strategy into regulatory overview documents such as cover letters premeeting package and other US specific regulatory positioning documents to assist Project Leaders in support of business needs <li> <ul><p><br ><b>Physical Requirements<b> <br >010 overnight travel required <br ><b>Qualifications<b> <br ><p><ul><li> A Bachelors degree required Life Science and advanced degree preferred <li> <li> A minimum of 4 years of progressively responsible related experience including hands on related pharmaceutical or medical devicepharmaceutical combination product experience and actual regulatory experience <li> <li> Advanced knowledge of pertinent FDA regulations <li> <li> Detail amp deadline oriented well organized <li> <li> Excellent verbal amp written communication skills <li> <li> Experience leading projects in specific regulatory area preferred <li> <li> Good interpersonal skills ability to interact with staff on all levels <li> <li> Knowledge of diabetes and diabetes management beneficial <li> <li> Previous supervisorymanagement experience advantageous <li> <li> Works independently with minimal supervision <li> <li> Previous hands on experience with compilation and filing of INDsNDAsAmendmentsSupplements <li> <ul><p><br >We commit to an inclusive recruitment process and equality of opportunity for all our job applicants <br >At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives backgrounds and cultures We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees the patients we serve and communities we operate in Together were life changing <br >Novo Nordisk is an equal opportunity employer Qualified applicants will receive consideration for employment without regard to race ethnicity color religion sex gender identity sexual orientation national origin disability protected veteran status or any other characteristic protected by local state or federal laws rules or regulations <br >If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply please call us at 18554115290 This contact is for accommodation requests only and cannot be used to inquire about the status of applications<p>