Medical Science Liaison/Sr. MSL - IL
Remote
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries.:
Medical Science Liaison
The Opportunity:
Our Medical Science Liaison is the medical / scientific voice of expertise for Abbott Diabetes Care (ADC) products and therapeutic areas. This field-based role focuses on medical & scientific engagement with ADC stakeholders. Provides medical / scientific expert advice / guidance to key customers for ADC products & relevant therapeutic areas, including scientific exchange & professional development with key thought leaders / external experts and provides medical / scientific affairs support to the US commercial team.
The Medical Science Liaison serves to support the scientific credibility of ADC with established and emerging national & regional thoughts leaders, by supporting scientific dialogue and collaboration in areas of research, scientific publications, and medical & scientific exchange, including unsolicited requests for medical information. They also interface regularly with appropriate US commercial team members. They maintain a high level of knowledge to ensure credible dissemination of scientific information and dialogue with thoughts leaders, healthcare providers and healthcare organizations.
What you will do:
Provide scientific and medical leadership to ensure professional and credible relationships with thought leaders and external experts of strategic importance to ADC.
Ensure a strong medical and scientific presence for ADC in key academic centers by facilitation of research and educational initiatives, while supporting requests for medical and scientific information on products or areas of therapeutic interest to ADC.
Work collaboratively and cross-functionally with other in-field members while retaining functional independence.
Serve as a point of contact within the medical and scientific affairs team for thought leaders and external experts within an assigned geographic area in order to satisfy their needs for scientific knowledge in a therapeutic area and, when requested, relevant ADC products, to support their safe, effective and appropriate use.
Deliver credible presentations on scientific matters to health care providers, individually or in groups (meetings, clinical sessions, etc.), where requested, with the focus on Tier 1 and 2 thought leaders.
Participate in the selection process to identify appropriately qualified thought leaders, ADC would wish to engage in collaborative efforts - such as educational and advisory roles (Advisory Boards, Congresses, Symposia, etc.) while ensuring a high level of scientific or educational integrity in these collaborative efforts.
Attend relevant scientific meetings and conferences. Collaborate with internal stakeholders to develop summaries of key data and other scientifically relevant information to inform ADC strategic priorities and initiatives. Staff the Medical Affairs area of the exhibit booth at national scientific meetings and congresses
Provide key thought leaders / external experts with scientific and technical support for publications of scientific or medical interest.
Ensure that all activities and interactions are conducted with due regard to all applicable local and national laws, regulations, guidelines, codes of conduct, company policies and accepted standards of best practice.
Qualification Requirements:
Bachelor's Degree in a health sciences field
Preferred Advanced degree (eg. PharmD, MD/DO, NP/DNP, PA, PhD) in a relevant scientific discipline is preferred but candidates with an undergraduate degree in a relevant discipline and demonstrated experience will be considered.
Licensure/Board Certification required. Clinical licensure and board certification (eg: Nurse Practitioner, Physician Associate or Pharmacist), in accordance with applicable. state and/or national regulations. Board certification must be current and relevant to the clinical scope of practice.
Minimum 3- 5 years in a health sciences field
**This job description is not to be considered an exhaustive statement of duties, responsibilities or requirements and does not limit the assignment of additional duties for this role.
The base pay for this position is
$111,300.00 - $222,700.00
In specific locations, the pay range may vary from the range posted.
JOB FAMILY:Medical & Scientific AffairsDIVISION:ADC Diabetes CareLOCATION:United States of America : RemoteADDITIONAL LOCATIONS:WORK SHIFT:StandardTRAVEL:Yes, 75 % of the TimeMEDICAL SURVEILLANCE:NoSIGNIFICANT WORK ACTIVITIES:Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day), Driving a personal auto or company car or truck, or a powered piece of material handling equipment, Keyboard use (greater or equal to 50% of the workday) Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.EEO is the Law link - English: ************************************************************ EEO is the Law link - Espanol: ************************************************************
Auto-ApplyClinical Site Lead - Los Angeles
Remote
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries.JOB DESCRIPTION:
Summary
The Clinical Site Lead drives study execution and operational excellence across Abbott Cardiovascular therapies (Vascular, Cardiac Rhythm Management, EP, Structural Heart, and Heart Failure). Recognized resource in protocol execution, increasing product and disease state knowledge, procedure support (as needed), procedure outcomes and early indication of trends, clinical trial enrollment, and ICH-GCP and clinical research application.
Adheres to specified site nomination, qualification, and startup processes. Leads ongoing training/retraining of all site stakeholders to ensure protocol adherence. Continuously reviews, manages, and influences all aspects of site's recruitment and data collection performance (enrollment, discrepancy resolution, compliance, etc.). Proactively utilizes appropriate operational metrics to minimize screen failure, attrition rate, etc. Monitors to ensure compliance with applicable regulatory requirements, Good Clinical Practice, and accuracy standards inclusive of site initiation, periodic, and close-out visits.
May be consulted in the following areas: study design, site payments, site audits, local document review, study documents preparation, and submission to site or competent authority/ethics committee.
Main Responsibilities
With limited direction from leadership:
1. Develop and maintain a productive clinical territory:
Identify, develop, and maintain sites capable of delivering start-up goals, study participation levels and required data quality.
Understand and assess investigators' interests and qualifications.
Identify appropriate investigators as defined by study-specific requirements and by the applicable regulatory code.
Maintain open communication and relationships with key site personnel including the Principle Investigator, Research Coordinator, as well as regulatory and legal personnel.
Provide ongoing technical support to customers and field staff.
Facilitate communication between clinical sites and other Abbott clinical staff (e.g., operations management, study team, Site Contracts Associate), as needed.
2. Manage all aspects of study lifecycle to include site regulatory and quality:
Start Up
Nominate, approach, and complete qualification processes including establishing site/sponsor expectations for study execution.
Facilitate all aspects of the start-up process and site initiation visits
Understand regulatory and legal requirements for study participation at a level that allows for appropriate collaboration with Abbott clinical staff, e.g. Site CRA, Site Contract Associate.
Train facility staff regarding protocol requirements and technology.
Enrollment
Develop site-specific strategies to promote appropriate patient enrollment.
Identify site successes and challenges and assist in implementing techniques that promote study goal achievement.
Continuously evaluate site study performance and provide timely feedback to site.
Attend study procedures and follow-ups when indicated (or ensure trained personnel attend).
Regulatory and Quality
Core level Abbott certification and/or equivalent level proficiency
Develop site-specific strategies to avoid deviations.
Educate site on tools to facilitate compliance.
Provide timely feedback to the sites on key compliance indicators.
Escalate non-compliant sites according to corporate policy.
Collect essential documents, identify and obtain missing data, data corrections, reviewing adverse events and protocol deviations.
Review data and source documentation from investigational sites for accuracy and completeness
Facilitate resolution of data queries and action items at clinical sites
Promptly reports the findings of monitoring visits according to Abbott processes.
Maintain accurate, detailed and complete records of monitoring visits.
3. Provide training and procedure coverage:
Apply clinical and technical expertise to train site and Abbott staff for clinical trials and applicable commercial launches.
As needed, provide clinical and technical expertise for clinical trial procedure support
Attend study procedures and follow-ups (or ensure trained personnel attend).
4. Collaborate with commercial partners:
When appropriate, collaborate in the education of local sales groups on new product launches.
When appropriate, contribute to the education of customers on new and existing Abbott products.
Meet with key customers where Abbott GCO presence can elevate the customer experience.
Act as an additional resource for technical questions and troubleshooting.
5. Identify and adapt to shifting priorities and competing demands.
6. Remain current on developments in the field of expertise including clinical and Abbott product knowledge, competitive positioning and published scientific and economic evidence.
Maintain at least one area of expertise and function as a local clinical and technical resource.
7. Possess independent problem-solving skills and ability to make decisions.
8. Exhibit excellent oral and written communication skills.
Require Qualifications:
Bachelors Degree (± 16 years) Related field OR an equivalent combination of education and work experience
Working technical knowledge and application of concepts, practices and procedures. General understanding of business unit/group function. Will perform this job in a quality system environment. Failure to adequately perform tasks can result in noncompliance with governmental regulations. Works on problems of moderate scope where analysis of situations or data requires a review of identifiable factors. Exercises judgment within defined procedures and practices to determine appropriate action. Has a broad knowledge of technical alternatives and an understanding of their impact on the systems environment.
Minimum 2 years Related work experience with a good understanding of specified functional area
Preferred Qualifications:
Bachelor's Degree Or Master's Degree in engineering, science, health science, nursing, or a related field, OR equivalent or related experience in cardiology or clinical research.
2 + years of progressively more responsible relevant clinical trial experience in the cardiovascular field.
Competency in catheterizaion lab and operating room protocol and procedures.
Ability to travel approximately 75%, including internationally.
The base pay for this position is
$60,000.00 - $120,000.00
In specific locations, the pay range may vary from the range posted.
JOB FAMILY:Clinical Affairs / StatisticsDIVISION:MD Medical DevicesLOCATION:United States > California : RemoteADDITIONAL LOCATIONS:WORK SHIFT:StandardTRAVEL:Yes, 50 % of the TimeMEDICAL SURVEILLANCE:NoSIGNIFICANT WORK ACTIVITIES:Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday) Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.EEO is the Law link - English: ************************************************************ EEO is the Law link - Espanol: ************************************************************
Auto-ApplyStrategic Account Executive -- Chicago
Chicago, IL jobs
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries.JOB DESCRIPTION:
About Abbott
Abbott is a global healthcare leader, creating breakthrough science to improve people's health. We're always looking towards the future, anticipating changes in medical science and technology.
Working at Abbott
At Abbott, you can do work that matters, grow, and learn, care for yourself and your family, be your true self, and live a full life. You'll also have access to:
Career development with an international company where you can grow the career you dream of.
Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
An excellent retirement savings plan with a high employer contribution
Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit - an affordable and convenient path to getting a bachelor's degree.
A company recognized as a great place to work in dozens of countries worldwide and named one of the most admired companies in the world by Fortune.
A company that is recognized as one of the best big companies to work for as well as the best place to work for diversity, working mothers, female executives, and scientists.
Abbott Diabetes Care: Poised for Growth
Since 2017, ADC has doubled in size due to the commercial successes of our Freestyle Libre glucose monitor. We are now generating over $2 billion in annual sales with even more growth ahead of us.
The Opportunity
This position is a remote opportunity in the Abbott Diabetes Care Division. We are helping people with Diabetes lead healthier, happier lives. As a global leader in diabetes care, Abbott is constantly working to deliver the highest quality products and unwavering support to our customers. Consistent and accurate glucose monitoring is the foundation of any diabetes management plan, so we're committed to continuous improvement in the way patients and professionals measure, track and analyze glucose levels.
As a Strategic Account Executive (SAE), you will be responsible for driving key partnership goals within assigned health system accounts. The SAE will use a consultative approach to partner with health systems and drive broader adoption of ADC's continuous glucose monitoring (CGM) portfolio within the health systems' diabetes patient population. The position requires exemplary customer and account management acumen and an aptitude to work with cross-functional teams. This is a critical role in Abbott Diabetes Care's (ADC) commercial strategy and will report to the Director of Strategic Accounts (DSA). This is a field based opportunity.
What You'll Do
Lead the development of key account plans based on gathering customer insights, identifying unmet needs in diabetes management, and having a deep understanding of Abbott's partnership solutions to ensure seamless execution of the resulting account strategies
Build and maintain deep relationships, and act as a thought partner with key decision-makers and influencers across a range of business functions (e.g., C-suite, VP and Director-level administration, Quality, Primary Care, Endocrinology, Population Health, Health Equity, IT/EMR/EHR, Pharmacy, and other relevant stakeholders) to strengthen the perception of ADC as a trusted resource in helping to improve patient outcomes and addressing diabetes management challenges within health systems
Identify needs and hypothesize solutions for key stakeholders at assigned health systems regarding unmet needs in diabetes management
Develop strategies and tactical plans to tailor and implement solutions that drive awareness of CGM, create HCP access for the field teams, and accelerate adoption of CGM for diabetic patients within the health system
Collaborate and orchestrate key activities with the cross-functional account team and relevant HQ-based functional stakeholders to drive development and pull-through of strategy, tactical plans, and solutions (e.g., workflow and technical solutions) in a compliant manner
Track and evaluate key customer metrics to proactively identify opportunities to adjust the account strategy to reflect changing dynamics
Maintain current knowledge of all ADC's products, indications and diabetes disease area to serve as an effective partner to assigned health system accounts
Experience You'll Bring
Required
Bachelor's degree
10 years+ years of experience in a customer facing field sales, sales management, or key account management role with 5+ years of experience in healthcare and / or life sciences industry
Demonstrated leadership skills, specifically in strategic influencing, effective communication, cross-functional collaboration, and conflict resolution
Demonstrated track record of business background including account planning, business planning, problem solving, and analytical skills
Possess executive presence and the ability to interact with senior account leadership
Demonstrated ability to develop customer-centric approaches, leveraging multi-disciplinary capabilities and resources to realize objectives
Ability to manage multiple, concurrent work streams across diverse functions
Demonstrated confidence, persuasiveness, ability to motivate others and ability to influence without formal authority
Willingness and ability to travel, including overnight 50% - 75%
Preferred
Advance degree preferred (Business or Science)
Experience in Key Account Manager position managing national or regional health system accounts
Diabetes disease area knowledge and experience promoting related products (e.g. glucose monitors, pumps)
Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: **********************
Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.
Connect with us at *************** on Facebook at *********************** and on Twitter @AbbottNews and @AbbottGlobal.
Divisional Information
Medical Devices
General Medical Devices:
Our medical devices help more than 10,000 people have healthier hearts, improve quality of life for thousands of people living with chronic pain and movement disorders, and liberate more than 500,000 people with diabetes from routine fingersticks.
CRM
As a global leader in Cardiac Rhythm Technologies, we focus on innovative technologies that can improve the way doctors treat people with heart arrhythmias, or irregular heartbeats.
Diabetes
We're focused on helping people with diabetes manage their health with life-changing products that provide accurate data to drive better-informed decisions. We're revolutionizing the way people monitor their glucose levels with our new sensing technology.
Vascular
Abbott Vascular provides innovative, minimally invasive, and cost-effective products for treatment of vascular disease.
Neuromodulation
Our Neuromodulation business includes implantable devices compatible with mobile technology to help people who suffer from chronic pain and movement disorders. These non-opioid therapies allow us to provide interventional pain therapy to patients throughout the pain continuum.
Structural Heart
Structural Heart Business Mission: why we exist
Our business purpose is to restore health and improve quality of life through the design and provision of device and management solutions for the treatment of structural heart disease.
EP
In Abbott's Electrophysiology (EP) business, we're advancing the treatment of heart disease through breakthrough medical technologies in atrial fibrillation, allowing people to restore their health and get on with their lives.
HF
In Abbott's Heart Failure (HF) business, we're developing solutions to diagnose, monitor and manage heart failure, allowing people to restore their health and get on with their lives.
Diagnostics
We're empowering smarter medical and economic decision making to help transform the way people manage their health at all stages of life. Every day, more than 10 million tests are run on Abbott's diagnostics instruments, providing lab results for millions of people.
Abbott Molecular is a leader in molecular diagnostics and the analysis of DNA, RNA, and proteins at the molecular level.
Our Point of Care diagnostic portfolio spans key heath and therapeutic areas, including infections disease, cardiometabolic, informatics and toxicology.
Our diagnostic solutions are used in hospitals, laboratories and clinics around the globe. The crucial information derived from our tests, instruments and informatics systems are often the first step in patient care decision making for hundreds of health conditions from heart attacks to blood disorders to infectious diseases and cancers.
Our rapid diagnostics solutions are helping address some of the world's greatest healthcare challenges.
Nutrition
Our nutrition business develops science-based nutrition products for people of all ages, from helping babies and children grow to keeping adult bodies strong and active. Millions of people around the world count on our leading brands - including Similac , PediaSure , Pedialyte , Ensure , and Glucerna - to help them get the nutrients they need to live their healthiest lives.
The base pay for this position is
$97,300.00 - $194,700.00
In specific locations, the pay range may vary from the range posted.
JOB FAMILY:Sales ForceDIVISION:ADC Diabetes CareLOCATION:United States of America : RemoteADDITIONAL LOCATIONS:WORK SHIFT:StandardTRAVEL:Yes, 25 % of the TimeMEDICAL SURVEILLANCE:NoSIGNIFICANT WORK ACTIVITIES:Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Driving a personal auto or company car or truck, or a powered piece of material handling equipment, Keyboard use (greater or equal to 50% of the workday) Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.EEO is the Law link - English: ************************************************************ EEO is the Law link - Espanol: ************************************************************
Auto-ApplyGlobal Safety Medical Director - Hematology/Oncology
Remote
Career CategorySafetyJob DescriptionJoin Amgen's Mission of Serving Patients
At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do.
Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.
Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.
Global Safety Medical Director - Hematology/Oncology
What you will do
Let's do this. Let's change the world. In this vital role you will be accountable for the staff management and resource allocations in Global Patient Safety and support GPS in the establishment of a highly effective global safety organization in full compliance to worldwide regulations. The GSO is accountable for the overall safety profile and all product-related decisions and results for assigned products supporting Hematology-Oncology portfolio. The GSO leads the Safety Analysis Team (SAT), Global Safety Team (GST) and is a core member of the Executive Safety Committee (ESC). The GSO also is a member of the Evidence Generation Team and other relevant cross functional teams. The GSO will be assigned as delegate for the TAH as needed.
Validate safety signals and lead safety signal assessments
Develop and maintain Core Safety Information (core data sheet, core risks in informed consent forms, etc.)
Prepare/review core and regional risk management plans including additional risk minimization measures
Prepare/review safety sections of periodic aggregate reports
Provide safety input to protocols, statistical analysis plans, and clinical study reports
Prepare/review safety sections of new drug applications and other regulatory filings
Serve as safety expert on Evidence Generation Team for assigned products
Inspection Readiness
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is a leader with these qualifications.
Basic Qualifications:
MD or DO degree from an accredited medical school
AND
Completion of an accredited medical or surgical residency
OR
Clinical experience in either an accredited academic setting or private practice (including hospital based) setting
Preferred Qualifications:
Product safety in the bio/pharmaceutical industry or regulatory agency
Previous management and/or mentoring experience
Experience in the study/research and/or treatment of Oncology disease states
What you can expect of us
As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way.
The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.
In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:
A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
Stock-based long-term incentives
Award-winning time-off plans
Flexible work models, including remote and hybrid work arrangements, where possible
Apply now and make a lasting impact with the Amgen team.careers.amgen.com
In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.
Application deadline
Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.
As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
.
Salary Range
243,245.00 USD - 319,267.00 USD
Auto-ApplyR&D Commercialization Project Management - Grad Intern
Remote
Career CategoryCollege JobJob DescriptionJoin Amgen's Mission of Serving Patients
At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do.
Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.
Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.
R&D Commercialization Project Management - Grad Intern
What You Will Do
Let's do this. Let's change the world. During this program, you will be assigned to 2-3 meaningful projects that supports the advancement of a product through the commercialization process, working with a cross-functional team of experts from R&D, Operations and/or Commercial, under the oversight of a Global Program Manager (GPM) Director.
You will gain an understanding of the drug development process and develop skills and capabilities in project management. Specifically, during your internship, you will be involved in the following activities:
Work with the GPM to support execute tactics, including effectively managing a project for a ‘Work Package Team (Evidence Generation Team, Product Delivery Team, or Integrated Brand Team) within our inflammation pipeline. The assigned product may be in early stage, late stage, or marketed.
Effectively operate as a Scrum Master for our Commercialization Tech & Reporting team. Responsibilities include facilitating agile ceremonies, running daily stand-up meetings, and helping manage JIRA boards and organizing work.
Develop a use-case for utilizing Artificial Intelligence (AI) to support Commercialization department, operationalize ways of working and streamline efficiencies for project management.
Ensure high quality deliverables, including developing timelines, are completed in a timely manner. Work in a cross-functional matrix environment, develop team management skills. Contribute to creating innovative solutions with other program managers.
Present in Commercialization Staff meeting.
What We Expect of You
We are all different, yet we all use our unique contributions to serve patients. The Project Management individual we seek is dynamic, goal-oriented and results driven with these qualifications:
Basic Qualifications:
Amgen requires that all individuals applying for a grad internship at Amgen must meet the following criteria:
18 years or older
Graduated with a bachelor's degree from an accredited college or university
Currently enrolled in an MBA program for an MBA internship OR a Master's program for a Master's internship OR a PharmD program for a PharmD internship OR Ph.D. for a PhD internship from an accredited college or university and completion of the first year of MBA OR Master's OR Pharm D OR Ph.D. program before the internship starts
Enrolled in an accredited college or university following the potential internship
Must not be employed at the time the internship starts
Student must be located in the United States for the duration of the internship
Preferred Qualifications:
Graduate Degree in Biotechnology, Pharmaceutical, or other Healthcare related field (acceptable degrees include: MSc, MSPH, MSRS, PharmD, PhD)
Certification in CAPM or PMP and/or general knowledge of Project Management principles, tools and practices, including Agile methodologies.
What You Can Expect of Us
As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way.
TThe base pay range for this opportunity in the U.S. is $30-$40 per hour
Build a network of colleagues that will endure and grow throughout your time with us and beyond.
Bring your authentic self to the table and become the professional you're inspired to be through accepting a culture that values the diversity of thought and experience and will flex to your strengths and possibilities.
Participate in executive and social networking events, as well as community volunteer projects.
Apply now and make a lasting impact with the Amgen team. careers.amgen.com - Please search for Keyword R-231687
In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.
Application deadline
Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.
Sponsorship
Candidates must be authorized to work in the U.S. for the duration of this program. Sponsorship for future FTE roles is not guaranteed.
As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
.
Salary Range
-
Auto-ApplyProfessional Education Relations Associate
Remote
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries.JOB DESCRIPTION:
Working at Abbott
At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You'll also have access to:
Career development with an international company where you can grow the career you dream of .
Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
An excellent retirement savings plan with high employer contribution
Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor's degree.
A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.
A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.
The Opportunity
The Professional Education Relations Associate is a Remote position within the Cardiac Rhythm Management Division.
The primary purpose of this role is to provide clinical and professional expertise for professional education programs. This role will contribute to the strategy and of education programs.
Using agility and creativity, the incumbent will be responsible for identifying and uncovering new training needs and gaps from sales and marketing leaders and Key Opinion Leaders physicians and allied health professionals
This role will work closely with HCPs, Professional Education program managers, and sales and marketing leaders to align initiatives that are developed, executed and measured for HCP engagement and impact.
What You'll Work On
Identify subject matter experts (physicians and allied professionals) for speaking and providing peer to peer training. Manage KOL relationships for professional education engagements. Manage faculty database and facilitate speaker's bureau.
Develop relationships with Clinicians at all levels; Fellows, EP, Cardiologists, Electrophysiology, AHP/APP, Hospital Administration.
Collaborate with key internal and external stakeholders (Marketing, Sales, physicians and allied professional, etc.) to gather inputs and feedback during analysis.
Provide clinical and professional Subject Matter Expertise, contributing to the design and development of professional education strategies and programs.
Establish and maintain strong cross functional relationships with the US commercial organization at the Area and Regional leadership level.
Support Professional Education Manager and Professional Education team during programs or as needed with full knowledge of all Professional Education programs and faculty.
Ensure positive customer/trainee/trainer experience and message consistency at programs and become an expert within the designated therapy.
Understand and articulate all Office of Ethics and Compliance policy and procedures, and report or enforce policies when required to maintain full division compliance.
Partner with Fellows program for seamless handoffs.
Identify standardized methods to evaluate impact of education programs and to continuously improve.
Drive a culture of best industry practices, technologies, and tools and as appropriate apply those best practices, technologies, and tools.
Comply with global regulatory relations and requirements, company policy, operating procedures, processes, and task assignment.
Keep current on developments in the field, specifically on product/therapy knowledge, market, and industry trends.
Maintain budget awareness of spending to meet department goals.
Performs related duties, on occasion, as assigned or required.
Required Qualifications
Bachelors Degree Science, preferably Medical Technology or Molecular Biology OR An equivalent combination of education and work experience
Minimum 7 years CRM or MedTech related experience
Ability to effectively communicate with external customers, Field Support, R&D, Quality, and Regulatory personnel to achieve needed results.
Preferred Qualifications:
Minimum 3 years of experience interacting with KOL physicians
CRM Clinical Field Experience
Deep understanding and knowledge of CRM device therapy and Abbott's CRM product portfolio
Affinity for educating others and a demonstrated ability to simplify and articulate complex topics effectively
Experience working with (presenting to, partnering/negotiating with) customers (payers, hospitals, and physicians), patients, professional and medical organizations
Insight and understanding of key KOLs within cardiovascular space
Functional understanding of Field and Marketing functions.
Demonstrated ability to collaborate with cross functional teams
Demonstrated experience successfully working across field-organizations to implement sophisticated messages and programs
Experience in identifying and driving operational change and excellence
Ability to work in highly matrixed organization and geographically diverse business environments
Ability to work within a team and as an individual contributor in a fast-paced, changing environment
Excellent verbal and written communication skills - proven track record to communicate and collaborate effectively
Excellent computer and software skills to develop presentation/training materials
Strong communication and project management skills
Ability to resolve issues and meet project deadlines
Job Requirements:
75% travel required (domestically and globally).
Apply Now
Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: **********************
Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.
Connect with us at *************** on Facebook at ************************** on Twitter @AbbottNews and @AbbottGlobal.
The base pay for this position is
$85,300.00 - $170,700.00
In specific locations, the pay range may vary from the range posted.
JOB FAMILY:Support ServicesDIVISION:CRM Cardiac Rhythm ManagementLOCATION:United States of America : RemoteADDITIONAL LOCATIONS:WORK SHIFT:StandardTRAVEL:Yes, 75 % of the TimeMEDICAL SURVEILLANCE:Not ApplicableSIGNIFICANT WORK ACTIVITIES:Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday) Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.EEO is the Law link - English: ************************************************************ EEO is the Law link - Espanol: ************************************************************
Auto-ApplyAssociate Director, Field Medical Operations and Capabilities
Remote
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.
Associate Director, Field Medical Operations and Capabilities
Organization Overview:
Global Field Medical Strategy & Operations serves to maximize the impact of the Field Medical community through standardized tools, innovation, and processes, with a goal of improving patient outcomes around the globe. As a function within Global Medical Affairs Capabilities and Innovation, operationalizing the Medical Affairs strategy to the personal channel is our purpose. MSL customers include Scientific and Clinical Experts. These are HCPs (Health Care Professional) with noted expertise and needs for in-depth and cutting-edge information. The Medical Science Liaison (MSL) program is designed to meet these needs through field-based medical professionals.
The Associate Director - Field Medical Operations and Capabilities role will partner across teams to lead operational & capability implementation. The Associate Director will play a central role in executing and operationalizing Medical Affairs initiatives to optimize global MSL impact through technology enablement.
At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing, and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.
The Field Medical Operations and Capabilities role is within the Field Medical Strategy & Operations (FMSO) team, a centralized Global Medical Affairs capability building team aiming to maximize the impact of Lilly's Field Medical (FM) community through standardized tools, innovation, and processes at scale.
This position reports to the Senior Director - Global Field Medical Operations and Capabilities.
Responsibilities:
Field Medical Operations and Capabilities
Drive the advancement of Field Medical capabilities, platforms, and processes. Examples include virtual capabilities, imbedding AI within capabilities, Engagement Planning, CRM management, global data enablement, content management, and reporting.
Lead FMSO India team to deliver world-class operations.
Monitor current technologies, data, processes, and industry insights to identify opportunities that optimize field operations strategy.
Partner with field medical teams to operationalize therapeutic area focus and lead territory sizing/structural needs aligned with priorities across BUs and/or global affiliates.
Maintain service levels in timeliness, performance and quality to support ongoing business needs.
Partner across Field Operations and lead through the execution of projects.
Answerable to the performance and results of FMSO capabilities.
Ensure compliance with company policies and local laws and regulations for Field Medical.
Technical Subject Matter Expert (SME)
Responsible for delivering and enabling innovative technologies and capabilities of current and future field operations capabilities, with a focus on imbedding AI across work streams.
Responsible for prioritization and agile delivery of aligned platform roadmaps, articulating requirements, and performing business user testing of releases of assigned platforms.
Perform duties as System Owner and business subject matter expert on Field Medical platforms enabling and accelerating reach and scale by the Global Medical Affairs function.
Provide knowledge and training support for all users of designated platforms.
Represent business in system governance and prioritization meetings.
Involve users and their feedback in development and implementation of tools and services.
Assure assigned platforms are operationally stable, and continuously improved based on data in partnership with Tech@Lilly.
Basic Requirements:
Bachelor's degree
3+ years of direct experience supporting field operations (i.e., field structure operations, engagement planning, reporting, etc.)
Previous experience working with Field Medical platforms, processes, and data products (i.e., CRM, Field Insights, H1, AI integration, etc.)
Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization and/or visas for this role.
Additional Skills/Preferences:
Demonstrated success in influencing without authority and achieving results through others
Demonstrated ability to develop and apply innovative solutions
MBA
Strong learning agility
Previous successful field operations experience
Previous experience providing operations and alignment support to field teams
Strong analytical mindset
Business enabling approach to work
Proven ability to communicate effectively & work with a variety of stakeholders
High level of motivation and a strong desire to find creative solutions to challenging situations
Proven ability to experiment, iterate, and innovate
Demonstrated broad and deep technology learning agility
Strong process and operational mindset
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (******************************************************** for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.
Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups.
Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$127,500 - $204,600
Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
#WeAreLilly
Auto-ApplyExport Customer Service Analyst
Shepherdsville, KY jobs
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at *******************
Job Function:
Customer Management
Job Sub Function:
Customer Service Operations
Job Category:
Professional
All Job Posting Locations:
Shepherdsville, Kentucky, United States of America, Somerset, New Jersey, United States of America, Titusville, New Jersey, United States of America
Job Description:
About Innovative Medicine
Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.
Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at *******************/innovative-medicine.
Apply today for this exciting opportunity to be part of our growing team!
Remote work options may be considered on a case-by-case basis and if approved by the Company.
The Export Analyst will be primarily responsible for ensuring that all international affiliate orders are processed accurately, compliantly and efficiently in accordance with all J&J SOPs, specific country shipping requirements and all Government Laws and Regulations. In addition, the Export Analyst will be responsible for integrating and/or streamlining the Export processes to best leverage J&J resources.
Key Responsibilities:
* Understand and optimize Export processes to improve lead times and efficiencies. Implement automation and digital improvements where possible.
* Advise management of changing needs of customer base and recommend process changes to accommodate customer requirements.
* Responsible for providing processes, troubleshooting, and solutions to Sr. Coordinators on Export team as it relates to system capabilities, processes, and affiliate management.
* Ensure adherence to all policies, procedures, regulations, and quality compliance (FDA, DEA, J&J QA standards) to be ready for internal and external audits
* Export Analyst will lead projects to support system upgrades, new product launches, new country launches, recalls, acquisition, and divesture activities as appropriate.
* Lead and support implementation of projects, ensuring clear and timely communication on status to business partners.
* Partner with Supply Chain, E2E Global Production Planning, Transportation, Operations, Controlled Substance Compliance, RD&S, etc. to resolve issues, complaints and/or adhoc inquiries.
* Investigate and research to resolve issues, present the data and effectively communicate action plan and resolution to affiliates and leadership, as the need arises.
* Develop deep knowledge of Export processes, country policies, metrics, and regulatory standards.
* Drive digital analytics to create and customize Export lead time metrics dashboard.
* Write and maintain SOPs in Tru-Vault to ensure all Export processes are clearly documented, standardized, and trained.
* Export Analyst will act as lead trainer for new resources and others as appropriate
Qualifications
Education:
* Minimum of a Bachelor's/University or equivalent degree is required
Experience and Skills:
Required:
* A minimum 3 years of working experience
* The ability to handle ambiguity within the J&J NA Deliver and Supply Chain enterprise
* Advanced order management systems knowledge
* Prior project work experience
* Analytical and/or Lean Thinking background
* Ability to work with individuals from different cultures and backgrounds
* Demonstrates an understanding of the supported franchises and business processes needed to achieve results.
* Understands relevant products and applies this knowledge to day-to-day responsibilities
* Customer-centric background
* Ability to build professional relationships across functions and sites, both internally and externally, to achieve shared goals
* Experience analyzing problems, issues, and situations.
* Ability to communicate expertly and effectively through multiple channels (i.e., phone, email, and other business correspondence)
* Ability to effectively present information and respond to questions from peers and supervisors / managers
Preferred:
* Knowledge and experience in import/export
Other:
* Ability to work non-standard hours due to Global affiliate business needs
* Ability to travel up to 10% of the time; international and domestic
For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit *********************
Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s):
* United States - Requisition Number: R-045234
* Canada - Requisition Number: R-047403
Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.
Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via *******************/contact-us/careers, internal employees contact AskGS to be directed to your accommodation resource.
Required Skills:
Preferred Skills:
Analytical Reasoning, Business Behavior, Customer Centricity, Customer Intelligence, Customer Service Philosophy, Customer Support Operations, Customer Support Platforms, Customer Support Policies and Procedures, Customer Support Trends, Data Analysis, Execution Focus, Issue Escalation, Mentorship, Order Processing, Service Excellence, Service Request Management
Auto-ApplySenior Global Quality Auditor
Remote
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.
Position Brand Description:The Sr. Principal Associate - Quality Auditor is part of the Global Quality Auditing and Compliance (GQAAC) division and provides quality assurance through the execution of internal and external audits in support of pharmaceutical development, non-clinical and clinical research, product commercialization, pharmacovigilance and consumer information quality (CIQ) for Lilly. Through auditing, the Sr. Principal Associate - Quality Auditor assures that GXP operations conducted and sponsored by Lilly are performed in accordance with company standards, policies, procedures and practices and are compliant with current regulatory requirements and expectations and applicable guidelines and industry standards.GQAAC has adopted a proactive approach to ensure the effective implementation of a continuous quality assurance program. This program has the objectives of guaranteeing compliance with regulations in all geographies where Lilly operates and of further enhancing the quality of operations of Lilly and their contracted parties. The Sr. Principal Associate - Quality Auditor is an expert quality professional, acting as a key contributor to the development and execution of the GQAAC audit program within the GXP area(s) of responsibility.Key Objectives/Deliverables:The following activities will be performed according to current GQAAC procedures, guidelines and tools. These responsibilities are not intended to be all-inclusive:Auditing
Scheduling, preparing, conducting and reporting Global Quality audits and assessments of research and commercial operations, both internally and externally (contracted) to assess the level of compliance with company standards, policies, practices and procedures and current regulations and guidelines. This includes leadership of audit teams -including GXP- and ability to successfully execute a portfolio of complex audits as lead or solo auditor, as appropriate (e.g.: for cause, process and system audits, affiliates, large TPOs and pre-inspection audits). Performance of this work requires limited supervision.
Participate in mock-inspections, as appropriate.
Participate or lead the risk assessment of research and commercial operations. Integrate the information obtained through auditing and risk assessment and influence actions within and across GQAAC and the business areas involved/impacted.
Drive the escalation of any compliance issues or significant risks identified during audits or when conducting risk assessment.
Meet the requirements outlined in quality standards, quality manuals, policies, procedures, and tools.
This implies establishment and maintenance of a comprehensive knowledge of all applicable regulations, technical knowledge, and training to meet these responsibilities.Global Quality - Business Related Responsibilities:
Identify the need and drive the revision of GQAAC quality system documents when appropriate. Participate or lead the preparation and/or review of standards, policies, procedures and guidelines that are used to establish quality requirements, when needed.
Participate or lead the preparation of organizational metrics and trending of audit findings, when required.
Provide advice to research and manufacturing operations on the interpretation of corporate and regulatory GXP requirements, when required.
Establish and maintain relationships with relevant regulatory authorities, including supporting or facilitation of regulatory inspections, when required.
Provide technical expertise in identifying, formulating, assembling and delivering quality and compliance education to customers, as required.
Influence internal and external customers and partners when improvement needs are identified.
Continuous Improvement Related to Role
Participate in the continuous improvement agenda related to the role to ensure compliance within a continually changing company, regulatory and industry landscape.
Represent assigned process within broader change and transformation initiatives.
Partner with GPhV risk assessor to drive innovation, simplify and standardize audit processes, including implementation of risk-based paper-based audit programs, where appropriate.
Enable successful implementation of GQAAC Management/Lead team technical strategies and improvements.
Personal Development
Maintain good interpersonal and communication skills with auditees and business areas with particular emphasis on verbal and technical writing skills.
Complete required training identified in the Individual Learning Plan
Be continually aware of current industry trends and regulatory agency interpretation of GXP requirements.
Seek self-development in GxP areas (e.g. grand rounds, attend training courses, conferences or association meetings) and share such information and knowledge with other members of the group or company to increase internal intelligence.
Mentor others in the implementation of GXP requirements.
Participate or lead divisional improvement efforts, including Six Sigma projects and departmental teams.
Act as a proactive coach for others within the organization: focused on systematic execution under highest standards of quality. The Sr. Principal Associate - Quality Auditor is considered a person of reference within the function / team for technical and general auditing advice.
Minimum Requirements:
Bachelors Degree - Preferred degree in physical or biological sciences, or other technical area.
Minimum of five (5) years' experience related to Pharmacovigilance (PV) or pharmaceutical industry.
Additional Preferences:
Experienced in working with Third Party Organizations.
Ability to analyze detailed technical scientific information, while understanding the bigger picture. The senior auditor should be able to clearly identify and assess risk and impact associated with specific and overall findings and situation for an auditable unit, event or case, and to articulate such risk and impact when communicating to the business (including senior management) and the quality organizations.
Ability to interpret and apply regulations, regulatory guidance, codes and public expectations, and identify and recommend compliance changes as appropriate.
Excellent interpersonal skills, ability to remain constructive and civil in difficult situations.
Ability to deliver timely and professional communications (oral and written) with precision and clarity to all levels of the organization.
Experienced in working on a global team and sharing knowledge.
Experience with computers, entering and managing data in databases.
Good analytical/problem-solving skills.
Ability to handle several complex projects in parallel.
Systematic approach to ensure self-safety and that of the audit team.
Work under pressure on multiple tasks concurrently and meet deadlines in a fast-paced work environment with frequent interruptions and changing priorities.
Proven ability to think and analyze from a process perspective. Project management skills.
Process information to identify linkages and trends and apply findings to compliance strategies as well as to individual assignments.
Work independently as well as collaboratively within a global team environment.
Deliver constructive feedback to customers while providing a high level of customer service.
Ability to influence and manage change/conflict.
Ability to think on your feet and be pragmatic in decision making.
Other Information: Domestic and international travel is required to fulfill these job responsibilities. Must be able to travel up to 40% (duration 1-2 weeks), sometimes on short notice.
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (******************************************************** for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.
Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups.
Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$65,250 - $187,000
Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
#WeAreLilly
Auto-ApplyField Service Engineer (Transfusion Service Ambassador) (Las Vegas, NV)
Las Vegas, NV jobs
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries.JOB DESCRIPTION:
Field Service Engineer (Transfusion Service Ambassador)
Working at Abbott
At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You'll also have access to:
Career development with an international company where you can grow the career you dream of.
Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year
An excellent retirement savings plan with high employer contribution
Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor's degree.
A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.
A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.
The Opportunity
This position is a remote position
Qualified candidates must currently live in the Las Vegas, NV. area
Travel up towards 50%
What You'll Work On
Responsible for providing on-site support to Abbott Diagnostic Division (ADD) customers
Support field personal
Support District business objective and goals
Provide direction and develop mentoring skills to mentor other FSRs
Troubleshooting and resolving complaints reported by customers on complex medical instruments.
Understand and follow Quality System. This includes Accurate and timely documentation of complaint resolution, Understand and practice regulatory and compliance procedures, maintain a safe work environment following laboratory safety guidelines.
Schedule and complete routine preventive maintenance installations and other updates provided by Abbott.
Work effectively within a diverse and dynamic team environment.
Support on call rotation time, territory and inventory management.
Standby and after-hours responsibilities.
Flexible working hours.
Unpredictable Travel.
Travel for support of other territories and training.
Providing on-site critical account support inside and outside of district boundaries.
Responsible for IRL ownership to achieve organizational goals and customer satisfaction.
Responsible to work cross functionally to achieve customer satisfaction through direct communication within the local performance partnership teams (P2T).
Responsible to maintain ownership of customer issue until successful escalation or hand off takes place.
Required Qualifications
Bachelor's degree or equivalent relevant experience required.
Preferred Qualifications
Bachelors/Engineering Degree in Biomedical/Electrical/Mechanical Engineering or Medical Technology.
Practical experience of interfacing with customers.
Troubleshooting/problem solving; ability to succeed in team situations and excel independently, computer skills (Word; Excel, Power Point, Internet, Remote Computing i.e VPN, remote troubleshooting etc.), effective communication skills and strongly demonstrated interpersonal skills.
Apply Now
Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: **********************
Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.
Connect with us at *************** on Facebook at *********************** and on Twitter @AbbottNews.
The base pay for this position is
$31.60 - $63.20/hour
In specific locations, the pay range may vary from the range posted.
JOB FAMILY:Support ServicesDIVISION:TM Transfusion MedicineLOCATION:United States of America : RemoteADDITIONAL LOCATIONS:WORK SHIFT:StandardTRAVEL:Yes, 50 % of the TimeMEDICAL SURVEILLANCE:Not ApplicableSIGNIFICANT WORK ACTIVITIES:Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day), Continuous walking for prolonged periods (more than 2 hours at a time in an 8 hour day), Driving a personal auto or company car or truck, or a powered piece of material handling equipment, Keyboard use (greater or equal to 50% of the workday), Lift, carry, push or pull weights of more than 20 pounds/9 kilos on a regular/daily basis Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.EEO is the Law link - English: ************************************************************ EEO is the Law link - Espanol: ************************************************************
Auto-ApplyDesign + Human Factors Engineering Senior Director
Remote
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.
Position Title: Design + Human Factors Engineering Senior Director -DDCS
Department Name: Delivery, Device and Connected Solutions
Purpose:
In 1992, Eli Lilly and Company established the Delivery Device business to create, develop, launch and continuously improve proprietary delivery device systems. This business is unique to the broader Lilly Research Labs organization due to its focus on patient-centered delivery system solutions, its innovative approach to delivery platforms utilizing both internal and external technologies, and its level of integration with the commercial groups and Business Units. The Delivery, Device and Connected Solutions (DDCS) organization leverages many alliances in design and manufacturing to rapidly convert proprietary product concepts into products that meet the users' needs and intended uses. This business enables over $30 billion in pharmaceutical sales and is projected to drive company growth in the coming years.
In response to this growing portfolio and increasing global regulatory expectations, the DDCS organization requires a Design and Human Factors Engineering Senior Director to provide leadership to support product innovation and product development for delivery and device systems at Eli Lilly and Company. This position is responsible for providing strategic direction, execution and reporting of design and human factors activities across all medical device, combination product and packaging programs, according to current regulations and appropriate guidelines within the medical device and biopharmaceutical industries.
Position responsibilities:
Design and Human Factors:
Lead and grow a top-tier engineering and science organization, which includes expertise in design and human factors engineering that is applied across the portfolio.
Ensures that:
Human capabilities and limitations are adequately reflected in the system requirements
Human performance characteristics and their associated cost, benefits, and risks assist in deciding among alternatives (especially since lifecycle operation and support costs are often largely dependent upon personnel-related costs)
Human performance and safety risks are appropriately addressed in planning.
The staff is highly trained in Human Factors processes, relevant standards (IEC 62366, ANSI/AAMI HE75) and FDA guidance.
Human Factors Standards are appropriately documented in the Design Control Quality System.
Project milestones are met by identifying and managing risks and escalating as appropriate.
Functional budgets and project forecasts are maintained in compliance with P&L
People:
Responsible for developing and managing the Design + Human Factors Engineering team.
Provides leadership, feedback, coaching, performance and career development support to direct reports.
Ensures career development discussions, talent assessment, and succession planning are in place for employees.
Builds and executes a comprehensive long-range recruiting strategy and technical succession plan to maintain a highly competitive cross-functional technical organization.
Strategy / Corporate Integration:
Given the anticipated growth in the delivery business both in terms of the existing base of business and future ventures, the Design & Human Factors Engineering Senior Director will be accountable for the execution of a Delivery and Device Strategy with other members of the management team.
The delivery strategy and project workload are closely linked to that of the Business Units, Sales Affiliates, Medical, Manufacturing and Marketing. The position would work closely with the above groups to consistently align the strategies and projects.
Partner with Regulatory to serve as an opinion leader in the drug delivery device and pharma industry on human factors and help draft policy positions across Lilly and the industry
Relationship Management:
Ensure compliance with external collaborations
Create and maintain effective relationships and alignment with Lilly partners external to DDCS (e.g. Quality, Manufacturing, Regulatory, Digital Health, Business Units)
Build strong relationships with external vendors and lead external collaboration efforts to support development strategies as they may evolve
Minimum requirements:
MS in Engineering with 10+ years or PhD in Engineering with 5+ years of delivery device design and development experience.
Experience with regulatory agencies interactions and/or regulatory submissions of delivery devices and combination products.
Experience working within a Sponsor organization
Working knowledge of HF regulatory requirements, protocols, IRBs, Usability studies and reporting.
Human subjects research bioethics and study design
Prior supervisory experience of team organization
Ability to work effectively across boundaries
Demonstrated quality mindset, ability to influence and leadership capabilities
Additional Skills and Preferences:
Understanding of and experience with device/drug regulations, standards and guidances as they pertain to specific functional responsibilities (e.g. CFR 820.30, ISO 13485, ISO 14971, IEC 62366, ANSI/AAMI HE75)
Business skills (capital and expense differentiation and impact on COGS and variance).
Communication and interpersonal skills necessary for broad interactions at all levels of the corporation.
Broad integrated technical knowledge of system and design engineering, product development, and commercialization (device, container closure, packaging, etc.).
Experience working in a diverse networked technical organization with proven skills in managing suppliers and alliance partners.
Leadership skills with previous experience managing technical personnel and alliance partnerships
Demonstrated ability to lead cross-functional teams
Additional Information
Position Location: Indianapolis, IN
Ability to travel ~10-20% of the time, both domestic and international
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (******************************************************** for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.
Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups.
Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$163,500 - $264,000
Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
#WeAreLilly
Auto-ApplyPharmaceutical Sales - Associate Territory Manager - Cardiometabolic Health
Remote
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.
Territory Manager - BEL AIR MD CMH2_170972
The Territory Manager will be accountable for account-based selling to health care providers (HCPs) who prescribe and influence the treatment for the disease states represented in the Lilly portfolio. This includes customers in multiple HCP specialties, as well as representatives in key hospital accounts. They will be viewed as a credible expert and resource supporting all medicines and appropriate brand patients.
The Territory Manager will be accountable for driving results by embracing Lilly's suite of models: Lilly Selling Model, Lilly Competency Model and Account Management Model to meet the needs of customers through strong execution. Territory Managers will drive consistent ways of working within the Regional Healthcare Market. They will build relationships with key customers to drive utilization and adoption of our medicines for the right patients. Specific responsibilities include the following:
BUSINESS OWNERSHIP
• Promotes the full portfolio of priority products with multiple HCP specialties.
• Understands the marketplace within the territory; evaluates and tailors the territory strategy to grow and own business outcomes.
• Navigates the ever-changing healthcare environment and payer landscape to increase understanding of accounts and be able to impact key stakeholders to become trusted partners.
• Utilizes appropriate business insight tools, data, and analytics to identify trends, priorities, opportunities, and potential obstacles.
• Implements and adopts new technologies, including the integration of AI company-approved tools and other analytical capabilities to streamline customer interactions.
• Identifies and advocates for new opportunities to enhance the customer experience.
• Models a growth mindset to create positive experiences.
SELLING SKILLS / CUSTOMER EXPERIENCE
• Embraces and uses the company's selling, competency and account management models to elevate performance and drive results.
• Demonstrates high learning agility to understand disease state, marketplace, clinical trials, and product label.
• Promotes the BU portfolio by planning for and engaging in patient-centered dialogues with customers.
EXECUTION / RESULTS
• Promotes across BU-portfolio and across HCP specialties, driving consistent ways of working within the Regional Health Care Market to meet customers' needs. Appropriately, fully utilizes the Virtual Medical Hub.
• Achieves targeted sales and execution metrics while adhering to company policies and procedures.
• Owns the customer relationship for product promotion, on-label medical questions, and general market access.
• Holds self-accountability for results and performance across all accounts, from individual HCPs to large health systems.
• Builds and maintains relationships with both internal and external partners to foster trust and create collaborative success.
BASIC QUALIFICATIONS
• Bachelor's degree.
• Professional certification or license required to perform this position if required by a specific state.
• Valid US driver's license and acceptable driving record is required.
• Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization and/or visas for this role.
ADDITIONAL SKILLS / PREFERENCES
• Demonstrated business ownership skills, selling/customer experience skills, and execution/results.
• Account based selling experience. Ability to identify and engage staff members in accounts.
• Strong learning agility, self-motivation, team focused, and emotionally intelligent.
• Bilingual skills as aligned with territory and customer needs.
• Residence within 30 miles of the territory boundary.
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (******************************************************** for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.
Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups.
Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$63,000 - $151,800
Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
#WeAreLilly
Auto-ApplyR&D Clinical Pharmacology Modeling & Simulation - Grad Intern
Remote
Career CategoryCollege JobJob DescriptionJoin Amgen's Mission of Serving Patients
At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do.
Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.
Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.
R&D Clinical Pharmacology Modeling & Simulation - Grad Intern
What You Will Do
Let's do this. Let's change the world. During this program, you will explore the applicability and impact of different types of mathematical/pharmacological models for modeling safety and efficacy of various disease treatments. This opportunity provides the intern with projects that involve
Crafting baseline models to benchmark performance in estimation and prediction in disease models
Building appropriate modules/software scripts and associated visualizations to assess validity and performance of models
Extending/Improving the model capabilities to increase performance in estimation and prediction
What We Expect of You
We are all different, yet we all use our unique contributions to serve patients. . The motivated individual we seek is a team player with these qualifications:
Basic Qualifications:
Amgen requires that all individuals applying for a grad internship at Amgen must meet the following criteria:
18 years or older
Graduated with a bachelor's degree from an accredited college or university
Currently enrolled in an MBA program for an MBA internship OR a Master's program for a Master's internship OR a PharmD program for a PharmD internship OR Ph.D. for a PhD internship from an accredited college or university and completion of the first year of MBA OR Master's OR Pharm D OR Ph.D. program before the internship starts
Enrolled in an accredited college or university following the potential internship
Must not be employed at the time the internship starts
Student must be located in the United States for the duration of the internship
Preferred Qualifications:
Pursuing a PhD or PharmD in the pharmaceutical sciences, statistics, engineering or bio-mathematics discipline
Has inquisitive mind and interest and passion for modeling biological data
Has exposure to pharmacological models/clinical trial data
Has sound knowledge of ordinary differential equations systems and modeling
Has proficiency in R/Python/NONMEM.
Exposure to the biology of cancers/rare diseases a plus
What You Can Expect of Us
As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way.
The base pay range for this opportunity in the U.S. is $30-$40 per hour
Build a network of colleagues that will endure and grow throughout your time with us and beyond.
Bring your authentic self to the table and become the professional you're inspired to be through accepting a culture that values the diversity of thought and experience and will flex to your strengths and possibilities.
Participate in executive and social networking events, as well as community volunteer projects.
Apply now and make a lasting impact with the Amgen team. careers.amgen.com - Please search for Keyword R-231137
In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.
Sponsorship
Candidates must be authorized to work in the U.S. for the duration of this program. Sponsorship for future FTE roles is not guaranteed.
As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
.
Salary Range
-
Auto-ApplyRegulatory Policy and Intelligence - US Director
Remote
Career CategoryRegulatoryJob Description
HOW MIGHT YOU DEFY IMAGINATION?
If you feel like you're part of something bigger, it's because you are. At Amgen, our shared mission-to serve patients-drives all that we do. It is key to our becoming one of the world's leading biotechnology companies. We are global collaborators who achieve together-researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It's time for a career you can be proud of.
Regulatory Policy and Intelligence - US Director
Live
What you will do
Let's do this. Let's change the world. Global Regulatory Policy team engages regulators, industry and professional associations, and patient advocates externally and subject matter experts across Amgen to advance important policy issues within the U.S. aligned with Amgen's goals and priorities. In this vital role you will lead the development and articulation of Amgen's positions on regulatory policies that impact Amgen's business and will serve as a U.S. Policy Lead for Global Regulatory Policy and Intelligence.
Key Responsibilities include:
Masters a range of regulatory policy topics and provides strategic U.S> regulatory policy advice and guidance related to Amgen's product portfolio, including a focus on artificial intelligence and emerging regulatory technologies (e.g., cloud-based submissions)
Engages US regulatory authorities, industry, and professional associations at the policy level
Leverages key relationships with FDA staff and industry and trade association colleagues to advance Amgen's position related to regulatory policy
Coordinates the implementation of new U.S. regulatory policy and guidance across Amgen functions
Engages cross-functional teams to develop strategic/long-term plans for the development and implementation of policies
Masters a range of regulatory policy topics as assigned, including topics such as Chemistry, Manufacturing, and Controls (CMC), Precision Medicine, and Combination Products. Leads the development and execution of strategic plans for each assigned policy area.
Ensures that Amgen's regulatory policy positions are successfully represented to inform policy development and implementation
Fosters a reputation with regulators as being science-based, reliable and trustworthy by advocating sound for policies
Provides internal stakeholders (e.g., Global Government Affairs, R&D, Commercial, Legal) with a strategic regulatory policy perspective
Assists and advises senior leadership in selecting issues, establishing priorities and developing and implementing regulatory policy advocacy plans
Assists in creating the necessary infrastructure/processes for developing the regulatory policy and intelligence function
Win
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The regulatory policy and intelligence professional we seek has a deep knowledge and understanding of the U.S. regulatory environment and can provide insights to internal stakeholders, as well as shape the external regulatory environment to support Amgen priorities and has these qualifications
Basic Qualifications:
Doctorate degree and 4 years of related experience
Or
Master's degree and 7 years of related experience
Or
Bachelor's degree and 9 years of related experience
Thrive
What you can expect of us
As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way.
The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.
In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:
A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
Stock-based long-term incentives
Award-winning time-off plans
Flexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies.
Apply now and make a lasting impact with the Amgen team.
careers.amgen.com
In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.
Application deadline
Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.
Sponsorship
Sponsorship for this role is not guaranteed.
As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
.
Salary Range
188,796.00 USD - 222,457.00 USD
Auto-ApplyPrincipal Regulatory Affairs Specialist- Shockwave Medical
Santa Clara, CA jobs
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at *******************
**Job Function:**
Regulatory Affairs Group
**Job Sub** **Function:**
Regulatory Affairs
**Job Category:**
Professional
**All Job Posting Locations:**
Santa Clara, California, United States of America
**Job Description:**
Johnson & Johnson is hiring for a **Principal Regulatory Affairs Specialist- Shockwave Medical** to join our team. The position is **FULLY REMOTE** and can sit anywhere in the US.
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at *******************/.
Fueled by innovation at the intersection of biology and technology, we're developing the next generation of smarter, less invasive, more personalized treatments. Ready to join a team that's pioneering the development and commercialization of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease. Our Shockwave Medical portfolio aims to establish a new standard of care for medical device treatment of atherosclerotic cardiovascular disease through its differentiated and proprietary local delivery of sonic pressure waves for the treatment of calcified plaque.
**The Principal Specialist, Product Stewardship:**
+ Serves as the primary liaison between the J&J Product Stewardship team and Shockwave stakeholders (including R&D, Supply Chain, Quality, Regulatory Affairs, Finance, Packaging, Marketing, and others as required) with regards to product stewardship programs, helping to manage business risk and institutionalize product stewardship programs.
+ Supports global Product Stewardship activities associated with the following, and others as required:
+ Global REACH (Registration, Evaluation, Authorization, and Restriction of Chemicals) requirements
+ Global Restriction of Hazardous Substances (RoHS) requirements
+ Global Battery Regulations
+ Global Packaging and Packaging Waste Regulations
+ Other applicable environmental regulations under the purview of Product Stewardship
+ Develops systems for intake, assessment, and tracking of worldwide environmental product and packaging compliance requirements.
+ Liaises with new product development teams to ensure product stewardship and environmental sustainability requirements are considered during new product design and launch.
+ Works with appropriate internal and external stakeholders to ensure worldwide reporting obligations related to environmental and packaging requirements are met.
+ Creates and/or updates procedures to reflect changing environmental requirements, ensuring processes support the mining of data necessary to demonstrate compliance.
+ Advises management on trends in the global regulatory environment that may impact current or future Shockwave business.
+ Manages and provides updates on critical tasks for ongoing projects.
+ Develops skill set to enable value-added individual contributions working under moderate supervision.
+ Implements methods for planning, directing, coordinating, and controlling Product Stewardship regulatory affairs activities related to new and modified products worldwide in compliance with corporate policies and strategies.
+ Interprets new and changing government regulations and stewardship guidance to ensure compliance with regulatory/government standards and expectations.
**Requirements**
+ University/Bachelor's degree or equivalent, master's degree preferred, with emphasis on chemistry, engineering, or related sciences
+ At least 8 years experience in Regulatory Affairs, including 3+ years working with environmental sustainability and packaging regulations
+ Familiarity and knowledge of global product stewardship regulations (e.g., REACH, RoHS, Batteries, PPWR, CA Prop 65, WEEE, etc.)
+ Clear and effective verbal and written communication skills with diverse audiences and personnel
+ Ability to think analytically with excellent problem-solving skills
+ Demonstrated ability to strategize, create, implement and execute a program across multiple departments
+ Strong organization and time management skills, including the ability to prioritize multiple challenging project timelines in a fast-paced environment while ensuring collaboration, accuracy, and all deadlines are met
+ Applies Johnson & Johnson's Credo and Leadership Imperatives in day-to-day interactions with internal and external colleagues
_Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act._
_Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center (_ _********************************_ _) or contact AskGS to be directed to your accommodation resource._
**The anticipated base pay range for this position is :**
US : $105,000 - $169,050 / Bay Area : $121,000 - $194,350
Additional Description for Pay Transparency:
Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. Subject to the terms of their respective plans, employees are eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)). This position is eligible to participate in the Company's long-term incentive program. Subject to the terms of their respective policies and date of hire, Employees are eligible for the following time off benefits: Vacation -120 hours per calendar year Sick time - 40 hours per calendar year; for employees who reside in the State of Washington -56 hours per calendar year Holiday pay, including Floating Holidays -13 days per calendar year Work, Personal and Family Time - up to 40 hours per calendar year Parental Leave - 480 hours within one year of the birth/adoption/foster care of a child Condolence Leave - 30 days for an immediate family member: 5 days for an extended family member Caregiver Leave - 10 days Volunteer Leave - 4 days Military Spouse Time-Off - 80 hours Additional information can be found through the link below. *********************************************
Field Clinical Specialist - Shockwave - Remote - Colorado
Denver, CO jobs
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at *******************
Job Function:
MedTech Sales
Job Sub Function:
Clinical Sales - Hospital/Hospital Systems (Commission)
Job Category:
Professional
All Job Posting Locations:
Denver, Colorado, United States, Santa Clara, California, United States of America
Job Description:
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for humanity. Learn more at *******************/.
Fueled by innovation at the intersection of biology and technology, we're developing the next generation of smarter, less invasive, more personalized treatments. Ready to join a team that's pioneering the development and commercialization of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease. Our Shockwave Medical portfolio aims to establish a new standard of care for medical device treatment of atherosclerotic cardiovascular disease through its differentiated and proprietary local delivery of sonic pressure waves for the treatment of calcified plaque.
Position Overview
The Field Clinical Specialist is a visible position that will provide case support to physicians within certain territories. Case support will be done on peripheral and coronary interventional procedures in the pre-market and post-market phases of product development with the Shockwave Medical Intravascular Lithotripsy (IVL) technology. The Field Clinical Specialist will also play a critical role in clinical studies including device training, case support and ensuring timely data collection for clinical programs. Case support may be required to support other territories at certain times.
Essential Job Functions
* Physician and hospital staff training, and procedural case coverage to ensure the safe and effective use of medical devices.
* Effectively meet the needs of internal and external customers with a sense of urgency and drive.
* Present clinical study training materials based on investigational plans to support the safe and effective use of medical devices, inclining study protocol, instructions for use, core lab manuals and case report forms.
* Manage key study investigators; foster and maintain strong relationships through direct interactions with medical advisors and clinical leaders.
* Partner with other clinical research colleagues to meet business needs in the field including site re-training, data collection for timely database locks and resolution of critical issues.
* Administrative activities including training to procedures, manage territory travel and budgets.
* Other duties as assigned.
Requirements
* Minimum Bachelor's Degree in business, science, nursing or related fields, or equivalent experience.
* Minimum 2 years' experience directly supporting interventional or surgical procedures within a hospital setting OR, 1 year of industry, hospital-based life sciences, sales support experience. Cardiovascular industry experience preferred but not required.
* Working knowledge of clinical research, Good Clinical Practice (GCP) and regulatory compliance guidelines for clinical trials.
* A history of effective collaboration with regulatory agencies through clinical studies and market releases.
* Product knowledge including product vigilance and medical device reporting.
* High attention to detail and accuracy.
* Computer skills (MS Office products, word processing, spreadsheets, etc.).
* Finance and budgeting knowledge.
* Good prioritization and organizational skills.
* Excellent critical thinking skills.
* Excellent influencing and negotiation skills.
* High energy and results-oriented individual who is mature and successful in a business environment and is skilled in motivating and inspiring people.
* Entrepreneurial "hands-on" experience. Pro-active and "can do" attitude.
* Ability to consider and accept feedback and suggestions for continuous improvement.
* Works effectively on cross-functional teams. Demonstrated willingness to make decisions and to take responsibility for such.
* Effective written, verbal and presentation skills with all levels of customers and management.
* Ability to work in a fast-paced environment while managing multiple priorities
* Operate as a team and/or independently while demonstrating flexibility to changing requirements.
* There may be continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
* Significant travel >50% of time requiring the employee to be effective in a remote manner.
* Employee may be required to lift objects up to 40lbs or more. Employees will be required to work in an air conditioned office space and possibly perform some tasks in our non-temperature controlled warehouse space.
Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, please contact us via *******************/contact-us/careers or contact AskGS to be directed to your accommodation resource.
Required Skills:
Preferred Skills:
Business Behavior, Communication, Consulting, Cross-Selling, Customer Centricity, Customer Effort Score, Customer Retentions, Execution Focus, Goal Attainment, Hospital Operations, Innovation, Market Research, Medicines and Device Development and Regulation, Sales, Solutions Selling, Sustainable Procurement, Vendor Selection
The anticipated base pay range for this position is :
100,000.
Additional Description for Pay Transparency:
Potential Variable Comp 35K
Auto-ApplySecOps Engineer - Identity Operations Tech Lead
Remote
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.
Are you eager to make a significant impact in the cybersecurity field? We are seeking a Technical Lead role to infuse our team with innovative ideas and daring solutions. In this position, you will play a crucial role in delivering how our organization ensures secure, appropriate, and timely access to enterprise resources, while also supporting the capabilities that help us achieve and sustain our Identity and Access Management strategy.
What You'll Be Doing
The SecOps Engineer- Identity Operations Tech Lead role of Identity and Access Management (IAM) is a technical leadership role responsible for the delivery and support for the company's 24/7 identity platforms and services.
This role plays a critical part in ensuring the secure and efficient support of identity and access services within our organization. The responsibilities will encompass day-to-day operations, incident management, change management, and problem resolution related to IAM focusing on Authentication services. This role will also collaborate with cross-functional teams to maintain compliance, address risks, and enhance our IAM program. This includes working closely with the Operation Manager, the Service Leads and other Technical leads to ensure alignment of priorities, allocating resources effectively, and driving operational excellence.
What You'll Bring:
Team and Technical Leadership:
Recruit, hire and develop a high-performing identity operation engineers.
Provide coaching, career development, performance management and professional growth opportunities.
Foster a culture focused on innovation, continuous learning, and operational discipline.
Cultivate a diverse and inclusive team fostering different perspectives and backgrounds.
Keep abreast of the latest developments in IAM technologies, security threats, and regulatory changes.
Drive the adoption of innovative and creative solutions to address complex, global IAM problems.
Serve as technical lead and an escalation point for team members.
Operational Excellence:
Provide technical leadership in the execution and processes for escalations, incident management, change management, problem resolution and continuous improvement that enable the support of 24/7 services.
Continuously monitor IAM systems performance and health to ensure optimal operation. Perform regular maintenance tasks to prevent issues.
Respond promptly to system alerts and incidents, troubleshoot issues, and implement solutions to restore services as quickly as possible.
Manage and maintain all components of IAM systems. Ensure that all systems are up-to-date with the latest patches and security updates.
Analyze system performance metrics and make recommendations for improvements. Implement changes to enhance system efficiency and reduce downtime.
Maintain detailed documentation of system configurations, procedures, and incident reports. Provide regular status updates and reports to management.
Work closely with other IT teams, developers, and stakeholders to ensure seamless operation of services. Communicate effectively to resolve issues and implement changes.
Assess current system capacity and plan for future growth. Ensure that resources are allocated efficiently to meet demand.
Provide technical support to users as it pertains to issues and requests on Identity services.
Support response to audit and compliance requests pertaining to Identity services.
Develop and implement solutions to resolve identified problems. Ensure that solutions are tested and validated before deployment.
Perform detailed root cause analysis and document findings. Develop and implement corrective actions to prevent recurrence.
Proactively identify opportunities for process improvements and implement best practices to enhance problem management processes.
Your Basic Qualifications:
Bachelor's degree in Computer Science, Engineering or related technical field.
5+ years of proven experience in supporting, delivering and securing Identity and Access Management services.
5+ years technical experience with Entra ID and/or Active Directory.
5+ years of experience with authentication and authorization technologies and federated identity standards and protocols (multifactor authentication, certificate-based authentication, LDAP Kerberos, OAuth, SAML, OpenID Connect).
Additional Preferences:
Experience in privileged access management including CyberArk.
Experience with encryption, secrets management. internal certificate authority, public certificate provisioning, enabling certificate management, and/or digital signatures.
Experience with Microsoft Identity Manager.
Experience with IT service management (ITIL).
Effective collaboration with other technical counterparts, Leaders and Stakeholders, to deliver and support IAM solutions.
Ability to work with a distributed and virtual team.
Critical thinking, analytical skills, and thought leadership.
Excellent communication and presentation skills, and ability to adapt messaging for diverse audiences.
An understanding of common services used in cloud-based architecture, with experience in AWS and/or Azure, and awareness of cloud platform security and controls.
Relevant certifications such as CISSP, CISM, or similar.
Additional Information:
Remote or Hybrid Onsite if in Indianapolis, IN
Expected Shift Hours: 9:00 am - 6:00 pm US Eastern Standard Time (EST)
Participate in weekend on-call once per month
Travel 10-15 %
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (******************************************************** for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.
Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups.
Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$63,750 - $198,000
Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
#WeAreLilly
Auto-ApplyPrincipal Clinical Research Scientist - Abiomed
Cherry Hill, NJ jobs
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at *******************
Job Function:
Discovery & Pre-Clinical/Clinical Development
Job Sub Function:
Clinical Development & Research - Non-MD
Job Category:
Scientific/Technology
All Job Posting Locations:
Danvers, Massachusetts, United States of America
Job Description:
Abiomed, part of Johnson & Johnson's MedTech, is recruiting for a Principal Clinical Research Scientist.
Remote work options may be considered on a case-by-case basis and if approved by the Company
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at *******************/.
We are looking for a strong leader to support the development and design of Abiomed's global clinical studies with the focus on sound clinical evidence generation to drive better patient outcomes with the use of Abiomed products. The Principal Clinical Research Scientist will oversee clinical studies within the Clinical and Regulatory Affairs department. The ideal candidate will be able to directly influence a strong evidence generation engine for Abiomed products.
Primary Duties and Responsibilities:
Execute on Abiomed's scientific objectives within Abiomed-sponsored clinical studies
Serve as scientific lead on Abiomed-sponsored clinical studies, and be the point person for scientific questions during execution of these studies
Own protocol development, revisions, submission, and approval, including consensus building with study steering committee and principal investigators and communication with FDA
Work closely with biostatistics team to evaluate study design options and analyze study data to support study decisions related to protocol development and study execution
Support the production of trial-related interim analyses, hypothesis testing, publications, and presentations
Own steering committee meetings and serve as scientific lead on investigator/research coordinator meetings
Provide scientific support for development of electronic data capture (EDC) for Abiomed-sponsored clinical studies
Responsible for scientific content for all trial-related documents
Own annual and final report content development, and coordination of content from various stakeholders
Develop, maintain, and review periodic study reports - review for outliers, ranges, and potentially problematic data; identify and communicate root causes and suggest possible solutions, document data observations, and follow pre-established processes and procedures
Develop and execute publication/presentation charters for clinical studies
Ensure data analysis integrity for clinical studies within scope of role
Drive strong publication/presentation cadence for Abiomed sponsored clinical studies
Execute on the regulatory pathway required for new investigational devices and for indication expansion globally
Conduct literature review and clinical data review to support regulatory submissions and CERs
Cross-collaboration with other Medical Office departments
Job Qualifications:
Advanced degree in science or engineering; PhD or MD required
At least 5 years relevant post-graduate research experience
At least 3 years clinical science/research experience in cardiology/cardiovascular space or medical devices required
Medical device and/or industry clinical research experience strongly preferred
Experience with scientific contribution to large multicenter clinical trials required
Excellent communication and collaboration skills, comfortable presenting to company leadership and external key opinion leaders
Strong understanding of biostatistics
Strong publication history in peer-reviewed journals
Knowledge of healthcare ethics, compliance regulations
Strong work ethic, self-motivated, team player with strong interpersonal skills
Ability to travel up to 15% (domestic and international) to attend site visits, investigator meetings, and scientific conferences
Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, please contact us via *******************/contact-us/careers or contact AskGS to be directed to your accommodation resource.
Required Skills:
Preferred Skills:
Clinical Evaluations, Corrective and Preventive Action (CAPA), Drug Discovery Development, Entrepreneurship, Good Clinical Practice (GCP), Leadership, Medicines and Device Development and Regulation, Presentation Design, Regulatory Affairs Management, Relationship Building, Research Documents, Safety-Oriented, Scientific Research, Strategic Change, Study Management, Tactical Planning, Technical Credibility
The anticipated base pay range for this position is :
$174,250 - $235,750
Additional Description for Pay Transparency:
Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. Subject to the terms of their respective plans, employees are eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)). This position is eligible to participate in the Company's long-term incentive program. Subject to the terms of their respective policies and date of hire, Employees are eligible for the following time off benefits: Vacation -120 hours per calendar year Sick time - 40 hours per calendar year; for employees who reside in the State of Washington -56 hours per calendar year Holiday pay, including Floating Holidays -13 days per calendar year Work, Personal and Family Time - up to 40 hours per calendar year Parental Leave - 480 hours within one year of the birth/adoption/foster care of a child Condolence Leave - 30 days for an immediate family member: 5 days for an extended family member Caregiver Leave - 10 days Volunteer Leave - 4 days Military Spouse Time-Off - 80 hours Additional information can be found through the link below. *********************************************
Auto-ApplyAssociate Compensation & Benefits Tax Counsel
New Brunswick, NJ jobs
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at *******************
Job Function:
Finance
Job Sub Function:
Tax
Job Category:
Professional
All Job Posting Locations:
New Brunswick, New Jersey, United States of America
Job Description:
Johnson & Johnson is seeking an experienced Associate Compensation & Benefits Tax Counsel. This role is located in New Brunswick, New Jersey.
This position reports to the VP Compensation & Benefits Tax Counsel. The candidate will provide high level technical tax and legal advice to management in the administration of the company's worldwide employee compensation and benefit plans.
Incumbent is responsible for ensuring compliance with laws and regulations applicable to employee compensation and benefits. Specifically, incumbent will advise management regarding tax and legal requirements in areas including qualified retirement plans, stock based compensation, employee welfare benefit plans, employee fringe benefits, mergers, acquisitions & divestitures, plan asset investments, and executive compensation matters. The Associate Compensation & Benefits Tax Counsel will also advise on payroll withholding and reporting matters and other global employee compensation and benefits matters.
Remote work options may be considered on a case-by-case basis and if approved by the Company.
Position Requirements:
* A Juris doctor degree from an accredited law school is required.
* A minimum of one active state (or District of Columbia) bar admission is required.
* A minimum of 10 years of experience at a law firm, accounting firm and/or major corporation advising clients or management on a wide variety of employee compensation & benefits tax and legal matters is required.
* Working knowledge of the provisions of the Internal Revenue Code applicable to the taxation of employee compensation and benefits and of the Employee Retirement and Security Act of 1974 (ERISA) is required.
* Experience advising on compensation and benefits matters in mergers, acquisition, and divestiture transactions is required.
* Experience advising on plan asset investment matters is required.
* Incumbent will also require excellent business partnering and communication skills - specifically the ability to communicate highly technical matters to management whose knowledge may be more general.
Preferred Requirements/Competencies:
* Exposure to and general knowledge of the laws of some major non-U.S. jurisdictions with respect to employee compensation and benefit matters, reporting and withholding, and employee location compliance are preferred.
The expected base pay range for this position is $173,000 to $300,000.
- The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation's performance over a calendar/performance year. Bonuses are awarded at the Company's discretion on an individual basis.
Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short and long-term disability, business accident insurance, and group legal insurance.
Subject to the terms of their respective plans, employees are eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)).
This position is eligible to participate in the Company's long-term incentive program. 6
Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:
- Vacation - 120 hours per calendar year
- Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado -48 hours per calendar year; for employees who reside in the State of Washington -56 hours per calendar year
-Holiday pay, including Floating Holidays -13 days per calendar year
- Work, Personal and Family Time - up to 40 hours per calendar year
-Parental Leave - 480 hours within one year of the birth/adoption/foster care of a child
- Bereavement Leave - 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
- Caregiver Leave - 80 hours in a 52-week rolling period 10 days
- Volunteer Leave - 32 hours per calendar year
- Military Spouse Time-Off - 80 hours per calendar year
Additional information can be found through the link below.
For additional general information on Company benefits, please go to: - *********************************************
Required Skills:
Preferred Skills:
Agility Jumps, Audit Management, Consulting, Critical Thinking, Fiduciary Liability, Financial Analysis, Financial Reports, Financial Risk Management (FRM), Financial Trends, Leadership, Organizing, Process Optimization, Program Management, Tax Advising, Tax Compliance, Tax Management, Transparency Reporting
The anticipated base pay range for this position is :
173000-300000
Additional Description for Pay Transparency:
Auto-ApplySr. Field Clinical Engineer - Shockwave Medical
Santa Clara, CA jobs
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at *******************
Job Function:
R&D Operations
Job Sub Function:
Clinical/Medical Operations
Job Category:
Professional
All Job Posting Locations:
Santa Clara, California, United States of America
Job Description:
Johnson & Johnson is hiring for a Senior Field Clinical Engineer - Shockwave Medical to join our team. This role is fully remote.
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at *******************/.
Fueled by innovation at the intersection of biology and technology, we're developing the next generation of smarter, less invasive, more personalized treatments. Ready to join a team that's pioneering the development and commercialization of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease. Our Shockwave Medical portfolio aims to establish a new standard of care for medical device treatment of atherosclerotic cardiovascular disease through its differentiated and proprietary local delivery of sonic pressure waves for the treatment of calcified plaque.
The Sr. Field Clinical Engineer is responsible for the development and execution of site-specific recruitment strategies that result in meeting enrollment targets for Shockwave Medical clinical trials. In addition, the Sr. Field Clinical Engineer will provide case support on Shockwave Medical products including Reducer and intravascular lithotripsy (IVL). The Sr. Field Clinical Engineer will play a critical role in clinical studies including device training, case support, and ensuring timely data collection for clinical programs. This work is accomplished with oversight, requires contact with internal stakeholders, frequent travel to clinical trial sites, works closely with physician advisors, and is critical to business success.
Essential Job Functions
* Physician and hospital staff training, and procedural case coverage to ensure the safe and effective use of medical devices.
* Present clinical study training materials based on investigational plans to support the safe and effective use of medical devices, including study protocol, instructions for use, core lab manuals and case report forms.
* Provide clinical and technical support for key study investigators and clinical leaders at assigned sites.
* Partner with other clinical research colleagues to meet business needs in the field including study start-up, site training, data collection for timely database locks and resolution of critical issues.
* Administrative activities including training to procedures at site level.
* Collaborate effectively with internal stakeholders (Clinical Affairs, Medical Affairs, Marketing and Medical Education) and external parties (vendors and physician advisors) to ensure Shockwave Medical clinical trials meet established enrollment goals.
* Collaborate with internal and external stakeholders to develop a repository of recruitment/study awareness materials and tools.
* Collaborate with internal and external stakeholders to ensure site-specific recruitment plans are implemented and progress tracked.
* Develop and maintain strong relationships with site investigators and research staff to understand site recruitment and enrollment processes and resolve obstacles to enrollment to meet study goals.
* Partner with assigned physician advisors to create and deliver recruitment strategies.
* Partner with vendors that support recruitment activities.
* Other duties as assigned.
Requirements
* Bachelor's Degree in a scientific field of study or equivalent work experience.
* Minimum of 5 years of relevant experience with at least 3 years of experience directly supporting interventional or surgical procedures within a hospital.
* Knowledge and experience in supporting device pre- and/or post-market clinical studies is required including experience running investigational device exemption (IDE) trials.
* Thorough knowledge of Good Clinical Practice (GCP) is required.
* Ability to attain and maintain hospital credentials.
* Ability to work in a fast-paced environment while managing multiple priorities.
* Operate as a team and/or independently while demonstrating flexibility to changing requirements.
* Experience with electronic data capture (EDC) systems.
* Must have excellent verbal and written communication skills.
* High attention to detail and accuracy.
* Able to manage multiple project teams with guidance
* Proficient computer skills (Microsoft Word, Excel, PowerPoint, etc.)
* Must be able to travel approximately 80% mostly in the US and Canada, and potentially outside North America.
* May be required to lift up to 25 pounds.
Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, please contact us via *******************/contact-us/careers or contact AskGS to be directed to your accommodation resource.
Required Skills:
Preferred Skills:
Analytical Reasoning, Business Behavior, Clinical Operations, Clinical Research and Regulations, Clinical Trial Designs, Coaching, Communication, Ethical and Participant Safety Considerations, Innovation, Laboratory Operations, Office Administration, Preclinical Research, Problem Solving, Project Management, Project Scheduling, Research and Development, Study Management
The anticipated base pay range for this position is :
US $106,250 - $143,750 / Bay Area - $122,400 - $ 165,600
Additional Description for Pay Transparency:
Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. Subject to the terms of their respective plans, employees are eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)). This position is eligible to participate in the Company's long-term incentive program. Subject to the terms of their respective policies and date of hire, Employees are eligible for the following time off benefits: Vacation -120 hours per calendar year Sick time - 40 hours per calendar year; for employees who reside in the State of Washington -56 hours per calendar year Holiday pay, including Floating Holidays -13 days per calendar year Work, Personal and Family Time - up to 40 hours per calendar year Parental Leave - 480 hours within one year of the birth/adoption/foster care of a child Condolence Leave - 30 days for an immediate family member: 5 days for an extended family member Caregiver Leave - 10 days Volunteer Leave - 4 days Military Spouse Time-Off - 80 hours Additional information can be found through the link below. *********************************************
Auto-Apply