Global Safety Medical Director - Hematology/Oncology
Amgen 4.8
Remote Amgen job
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
$129k-182k yearly est. Auto-Apply 60d+ ago
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Grad Intern - Operations - Engineering/Sustainability - Remote (Summer 2026)
Amgen 4.8
Amgen job in Thousand Oaks, CA or 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.
Grad Intern - Operations - Engineering - Remote (Summer 2026)
What You Will Do
Let's do this. Let's change the world. This 13 week remote Graduate internship works with Amgen's Environmental Sustainability Team to access, reduce, and communicate the climate risk associated with a robust global manufacturing and supply chain. This role will involve the use of data science and programming skills to leverage existing models that evaluate the physical and financial risk Amgen may face from climate change across multiple global locations. Key responsibilities include:
Working with expert Engineers to craft, develop, and support engineering projects
Supporting Engineering assessments, technical feasibility, and lifecycle impact
Contributing to innovative programming of environmental risk assessments
What We Expect of You
We are all different, yet we all use our unique contributions to serve patients. The Engineering graduate intern we seek is a collaborative team-player with these qualifications:
Basic Qualifications:
Amgen requires that all individuals applying for a grad internship or a co-op assignment 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 or co-op assignment
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:
Experience with general office software applications (MS Word, Excel, PowerPoint, etc.)
Working understanding building and utilizing data models in Python (preferable) or R programming languages
Experience investigating supply chains and large-scale manufacturing assets
Experience giving presentations
Understanding of current and emerging sustainability reporting schemes such as CDP, CSRD, CSDDD
Experience analyzing climate risk with known frameworks such as Jupiter
Experience presenting environmental data and business impacts to diverse audiences
Experience working cross functionally with technical experts in different fields
Ability to lead and deliver results in an interactive matrixed environment
Strong written and oral communication skills, relationship building, and leadership skills
Able to manage time efficiently and work with minimum supervision
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 $30.00 - $40.00.
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-234912
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
-
$100k-131k yearly est. Auto-Apply 5d ago
Associate Director, Marketing
Gilead Sciences, Inc. 4.5
Remote or Santa Monica, CA job
We're here for one reason and one reason only - to cure cancer. Every moment is dedicated to developing treatments and every action moves us one step closer to our goal. We've made incredible scientific breakthroughs and our pioneering personalized CAR‑T cell therapies have changed the paradigm, but we're not finished yet.
Join Kite and help shape where our business and medical science goes next. You'll play a key role in the development of new cancer therapies and in creating an environment where every employee feels included, developed and empowered to fulfil their aspirations.
Job Description
We are seeking a highly motivated individual to join us as the Associate Director of Marketing focused on the LBCL indication. The Associate Director will play an important role in developing HCP promotion, cultivating an integrated LBCL strategy, and implementing a cross‑functional tactical plan to support and grow Yescarta's LBCL indication. This person will report to the head of LBCL within Kite's US Commercial Department.
Key Responsibilities of the Associate Director of Marketing - Yescarta include:
Develop and optimize brand strategies and marketing tactics using market research and analytics, ensuring accurate փmeasurement of promotional tactics.
Oversee the development and execution of annual brand plans, including long‑term strategic imperatives and short‑term tactical priorities. Champion cross‑functional alignment and ensure seamless execution across key stakeholders.
Develop and deliver differentiated brand and marketing concepts and materials, aligning with the brand's purpose, target customer needs, and industry trends.
Collaborate with the Promotional Review Committee (PRC) to create compliant and effective promotional tactics and ensure their effective implementation.
Formulate, develop, and implement strategic plans while escalating market challenges and barriers to leadership, proposing appropriate solutions.
Exhibit a “roll up your sleeves” attitude, demonstrating the ability to follow through on projects within tight timelines.
Adapt and thrive in an ambiguous, transformational environment.
Demonstrate leadership excellence in project management, effectively managing multiple projects and priorities, including agency collaboration and budget management.
Travel domestically up to 50%.
Basic Qualifications
Advanced degree (PharmD, PhD, or equivalent) with 5+ years of relevant experience in strategy consulting, pharmaceutical marketing, or biotechnology marketing OR
Master's Degree知 2+ years of relevant experience in strategy consulting, pharmaceutical marketing, or biotechnology marketing OR
Bachelor's degree with 10+ years of relevant experience in strategy consulting, pharmaceutical marketing, or biotechnology marketing OR
Associate Degree and 12+ years of relevant experience in strategy consulting, pharmaceutical marketing, or biotechnology marketing OR
High Schoolandaş Diploma/GED and 14+ years of relevant experience in strategy consulting, pharmaceutical marketing, or biotechnology marketing.
Preferred Qualifications
MBA or other advanced business degree.
8+ years of pharmaceutical or biotechnology experience.
Experience in marketing research and / or pharmaceutical sales.
Prior hematology / oncology or cell therapy experience, with in‑depth knowledge and experience in franchise‑specific market preferred.
Ability to leverage data to conduct analyses and use complex analytical tools to drive decisions.
Demonstrated excellence in project management and effectively managing multiple projects / priorities.
Ability to successfully work with external agencies, including advertising, public relations and medical education vendors to develop programs and materials.
Familiarity with marketing fundamentals, strategy, sales and commercial policies and practices.
Compensation & Benefits
The salary range for this position is: $177,905.00 心 $230,230.00. Kite considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligibleеспублик for a discretionary annual bonus, discretionary stock‑based long‑term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company‑sponsored medical, dental, vision, and life insurance plans*.
For additional benefits information, visit: ******************************************************************
* Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.
Equal Employment Opportunity
Kite Pharma is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, age, sexual yenye orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non‑job related characteristics or other prohibited grounds specified in applicable federal, state and local laws.
In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the влияет-era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact ApplicantAccommodations@gilead.com for assistance.
Location & Remote Work
Job Level: Associate Director
Remote Type: Onsite Required
Job Type: Full‑time
Location: Santa Monica, CA
#J-18808-Ljbffr
$177.9k-230.2k yearly 2d ago
2026 Summer Intern - Roche Group SHE
Genentech 4.5
Remote job
At Roche, SHE stands for Safety, Security, Health, and Environmental Protection, encompassing comprehensive efforts to protect our assets, employees, the public, and the environment from business-associated hazards. These principles are deeply entrenched in our corporate ethos, demonstrating our commitment to safeguarding people, the environment, and our resources. Our SHE strategic approach aligns with international standards, fostering innovation, continuous improvement, and responsible operations. This includes securing our employees, physical assets, critical information, and the integrity of our brands and products. By prioritizing prevention, systematic risk management, and transparent communication, we strive to create a sustainable future while enhancing global health and quality of life.
This position is based in Little Falls, NY / Fully remote.
The Opportunity
As an Intern within our Group SHE organization, you will support a range of analytical, operational, and administrative tasks that help protect our people, assets, and operations. This role is ideal for someone interested in security, risk management, investigations, compliance, or data analysis.
Data Analysis and Reporting: Assist in collecting, organizing, and analyzing data related to security activities, incidents, and key risk indicators. Create reports, visualizations, and dashboards that summarize trends, patterns, and insights for leadership and operational teams.
Case Management Support: Maintain accurate and up-to-date records of active cases in the case management system. Prepare case summaries and compile supporting documentation for ongoing security matters.
Research and Intelligence Gathering: Conduct online and database research to identify emerging risks, industry trends, and potential threats affecting the company. Monitor relevant news, regulatory updates, and market developments that may impact security operations.
Document Review and Compliance: Support the review of security, legal, or investigative documentation to ensure adherence to internal policies and applicable regulations. Assist with preparation for audits, assessments, and internal reviews.
Process Improvement and Administrative Support: Identify opportunities to streamline workflows, improve documentation practices, or enhance data accuracy. Provide administrative support to the team (e.g., scheduling, correspondence, organizing files and records).
Program Highlights
Intensive 12-weeks , full-time (40 hours per week) paid internship.
Program start dates are in May/June (Summer)
A stipend, based on location, will be provided to help alleviate costs associated with the internship.
Ownership of challenging and impactful business-critical projects.
Work with some of the most talented people in the biotechnology industry.
Who You Are (Requirements)
Required Education: You meet one of the following criteria:
Must be pursuing or have attained an Associate's Degree.
Must be pursuing a Bachelor's Degree (enrolled student).
Must have attained a Bachelor's degree (recent graduates not currently enrolled in a grad program).
Preferred Majors: Business, Data Analytics, Criminal Justice, or Pre-Law.
Required Skills:
Technical Skills: Basic proficiency in Microsoft Office Suite (Word, Excel, PowerPoint) and Google Suite.
Teamwork: Ability to collaborate effectively within a team environment and contribute to group objectives.
Analytical Abilities: Strong research and analytical skills to evaluate data and identify trends.
Project Management: Ability to manage multiple tasks and prioritize accordingly.
Preferred Knowledge, Skills, and Qualifications
Excellent communication, collaboration, and interpersonal skills.
Complements our culture and the standards that guide our daily behavior & decisions: Integrity, Courage, and Passion.
Familiarity with database or case management systems.
Computer literacy: Proficiency in using advanced digital tools and software.
Prioritization: Ability to rank tasks by importance and urgency.
Alignment with core values: Complements our culture and the standards that guide our daily behavior & decisions: Integrity, Courage, and Passion.
Familiarity with compliance and audit functions, with previous experience writing process documentation.
Knowledge with information security, including concepts such as risk management, vulnerability assessment, and threat modeling.
Experience leveraging AI tools to enhance research, analysis, and workflow efficiency, including drafting, data synthesis, and decision-support outputs.
Relocation benefits are not available for this job posting.
The expected salary range for this position based on the primary location of Little Falls, NY is $24- $33/hour. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. This position also qualifies for paid holiday time off benefits.
Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.
If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.
$24-33 hourly Auto-Apply 7d ago
Principal IS Business Analyst - Clinical Study Design and Analysis
Amgen 4.8
Remote Amgen job
Career CategoryInformation SystemsJob Description
Join 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.
Principal IS Business Analyst - Clinical Study Design and Analysis
What you will do
Let's do this. Let's change the world. Amgen is seeking a Principal IS Business Analyst to join the Clinical Study Design and Analysis (CSDA) product team. You will be responsible for "Run" and "Build" project portfolio execution, collaborate with business partners and other IS service leads to deliver IS capability and roadmap in support of business strategy and goals.
The role leverages domain and business process expertise to detail product requirements as epics and user stories, along with supporting artifacts like business process maps, use cases, and test plans for the software development teams. This role involves working closely with developers and business analysts to ensure that the technical requirements for upcoming development are thoroughly elaborated. This enables the delivery team to estimate, plan, and commit to delivery with high confidence and identify test cases and scenarios to ensure the quality and performance of IT Systems. You will collaborate with Product Managers and developers to maintain an efficient and consistent process, ensuring quality deliverables from the team.
Roles & Responsibilities:
Collaborates with System Architects and Product Managers to manage business analysis activities, ensuring alignment with engineering and product goals.
Captures the voice of the customer to define business processes and product needs.
Works with Product Managers and customers to define scope and value for new developments.
Collaborates with Engineering and Product Management to prioritize release scopes and refine the product backlog.
Ensures non-functional requirements are included and prioritized in the product and release backlogs.
Facilitates the breakdown of epics into features and sprint-sized user stories and participates in backlog reviews with the development team.
Clearly expresses features in user stories and requirements so all team members and stakeholders understand how they fit into the product backlog.
Translates complex business and technological needs into clear, actionable requirements for development teams.
Ensures acceptance criteria and definition of done are well-defined.
Works closely with UX to align technical requirements, scenarios, and business process maps with user experience designs.
Stays focused on software development to ensure it meets requirements, providing proactive feedback to stakeholders.
Develops and executes effective product demonstrations for internal and external stakeholders.
Maintains accurate documentation of configurations, processes, and changes.
Serves as a liaison between global DTI functional areas and global development scientists, prioritizing their needs and expectations.
Manages a suite of custom internal platforms, commercial off-the-shelf (COTS) software, and systems integrations.
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The professional we seek is an individual with these qualifications.
Basic Qualifications:
Doctorate degree and 2 years of Life Science/Biotechnology/Pharmacology/Information Systems experience
OR
Master's degree and 4 years of Life Science/Biotechnology/Pharmacology/Information Systems experience
OR
Bachelor's degree and 6 years of Life Science/Biotechnology/Pharmacology/Information Systems experience
OR
Associate's degree and 10 years of Life Science/Biotechnology/Pharmacology/Information Systems experience
OR
High school diploma / GED and 12 years of Life Science/Biotechnology/Pharmacology/Information Systems experience
Preferred Qualifications:
Must-Have Skills:
Excellent problem-solving skills and a passion for tackling complex challenges in drug discovery through technology.
Experience with Agile software development methodologies (Scrum).
Excellent communication skills and the ability to interface with senior leadership with confidence and clarity.
Experience in writing requirements for the development of modern web applications.
Experience in writing user requirements and acceptance criteria in Agile project management systems such as JIRA.
Good-to-Have Skills:
Demonstrated expertise in a clinical development domain and related technology needs.
Experience in managing product features for PI planning and developing product roadmaps and user journeys.
Familiarity with low-code and no-code test automation software.
Technical thought leadership.
Ability to communicate technical or complex subject matters in business terms.
Experience with Jira Align.
Knowledge of cloud platforms (AWS, Azure/Databricks, GCP) and enterprise infrastructure technologies.
Experience with DevOps, continuous integration, and continuous delivery methodologies.
Professional Certifications:
SAFe for Teams certification (preferred).
Soft Skills:
Able to work under minimal supervision.
Skilled in providing oversight and mentoring team members, with a demonstrated ability to delegate work effectively.
Excellent analytical and gap/fit assessment skills.
Strong verbal and written communication skills.
Ability to work effectively with global, virtual teams.
High degree of initiative and self-motivation.
Ability to manage multiple priorities successfully.
Team-oriented with a focus on achieving team goals.
Strong presentation and public speaking skills.
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
143,358.00 USD - 173,256.00 USD
$113k-142k yearly est. Auto-Apply 13d ago
R&D Access & Use Evidence Generation AI Use Case Delivery - Grad Intern
Amgen 4.8
Remote Amgen job
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 Access & Use Evidence Generation AI Use Case Delivery - Grad Intern
What You Will Do
Let's do this. Let's change the world. During this program, you will [support strategic exploration of artificial intelligence (AI) opportunities within the Access & Evidence Generation ecosystem. This internship will focus on identifying, structuring, and prioritizing AI use cases across real-world evidence (RWE), payer evidence generation, evidence operations, evidence strategic planning and performance management. The intern will conduct a structured assessment of current-state processes and future-state opportunities, developing end-to-end AI use case scenarios and associated business cases. This role is conceptual and strategic in nature and does not require model development or software engineering. It is well suited for a graduate student with strong analytical thinking, business acumen, and interest in applied AI in a regulated life sciences environment].
Assess the current state of Access & Evidence Generation processes, including RWE generation, payer evidence, evidence operations, and strategic planning.
Identify and articulate AI opportunity areas across the evidence lifecycle (e.g., automation, augmentation, decision support, optimization).
Develop end-to-end AI use case scenarios, including: Problem statement and business context, Target users and workflows
AI capability description (e.g., predictive analytics, NLP, decision intelligence)
Expected value and outcomes
Assumptions, dependencies, and constraints
Create business cases for proposed AI use cases, including: Value drivers (efficiency, quality, scalability, decision impact)
Qualitative and, where possible, quantitative benefit estimates
High-level feasibility and risk considerations (data, governance, compliance)
Conduct use case prioritization based on value, feasibility, and strategic alignment.
Synthesize findings into clear, executive-ready deliverables, including written analyses and presentation materials.
Collaborate with Medical Affairs Operations and relevant stakeholders to validate assumptions and refine recommendations.
What We Expect of You
We are all different, yet we all use our unique contributions to serve patients. The individual we seek is deeply excited about AI and solving manual workflow with automation using AI. They are creative, curious and self-motivated.:
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:
Experienced with ‘use case' development, in a graduate program focused on data science/analytics
Familiarity with one or more of the following: Real-world evidence (RWE) or Health Economics outcomes research (HEOR),Market access or payer evidence generation, Medical Affairs or evidence operations
Exposure to AI concepts such as machine learning, natural language processing, or decision intelligence (conceptual understanding sufficient).
Experience developing business cases, strategy frameworks, or process analyses.
Comfort working in ambiguous problem spaces and structuring open-ended questions
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-234081
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.
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Salary Range
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$30-40 hourly Auto-Apply 13d ago
Undergrad Intern - Inclusive Global Health and Impact (Summer 2026)
Amgen 4.8
Remote Amgen job
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.
Undergrad Intern - Inclusive Global Health and Impact (Summer 2026)
What You Will Do
Let's do this. Let's change the world. This internship will be approximately 12 weeks and includes both project-based and experiential learning. The intern will be an integral member of the Amgen Inclusive Global Health and Impact (IGHI) Team, which is dedicated to embedding impact at every step of the value chain-from molecule to market-by uniting science, strategy, and multi-sector partnerships
As a member of Amgen's IGHI Team, your work will be highly collaborative across multiple teams and levels within Amgen, including Representation in Clinical Research (RISE), Access to Health (ATH), and Health Impact. Additionally, you will have the chance to work cross-functionally with Research & Development, Corporate Affairs, Government Affairs, Health Equity, Advocacy Relations, Diversity, Inclusion & Belonging, and others. You will be uniquely responsible for one or more key projects that will advance the IGHI mission, including the following:
Developing a project charter to map out objectives and identify key stakeholders, timelines, and deliverables
Leveraging your analytical, leadership, communication, and interpersonal skills to work in teams, identify problems, conduct research, develop recommendations through qualitative and quantitative analysis, and deliver final projects
Presenting your deliverables/findings through various forums including an intern-wide poster session and a final readout to executive management
You will also be engaged in learning activities, networking with colleagues across the company, and enjoying full access to Amgen's Employee Resource Groups
What We Expect of You
We are all different, yet we all use our unique contributions to serve patients. The collaborative individual we seek is hard-working with these qualifications:
Basic Qualifications:
Amgen requires that all individuals applying for an undergrad internship or a co-op assignment at Amgen must meet the following criteria:
18 years or older
Currently enrolled in a full-time Bachelor's Degree program from an accredited college or university with a 3.0 minimum GPA or equivalent
Completion of one year of study from an accredited college or university prior to the internship commencing
Enrolled in a full-time Bachelor's degree program following the potential internship or co-op assignment with an accredited college or university
Must not be employed at the time the internship starts
Student must be located in the United States for the duration of the internship OR co-op
Preferred Qualifications
Pursuing a degree in Health Sciences, Psychology, Sociology, Communications, Business Administration, Public Health or a similar field
Strong written and verbal communication skills
Strong interest in public health, community health, social sciences, health equity, health policy, health communications, DEI (diversity, equity and inclusion), and/or other related fields
Strong organization and time management skills
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 $24.70 - $28.30 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-231691
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
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$24.7-28.3 hourly Auto-Apply 41d ago
Clinical Pharmacologist/Clinical Research Physician
Eli Lilly and Company 4.6
Remote job
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.
Purpose and Role
Lilly is seeking an individual with expertise in early clinical development, including clinical pharmacology, to join a passionate team with a robust, industry-leading pipeline. The ideal candidate will have expertise in diabetes, obesity, cardiovascular, renal or endocrinology drug development with demonstrated learning agility, a problem-solving mindset, and the willingness to develop knowledge and skills in new areas. The Clinical Research Physician (CRP) will be the clinician to progress multiple early clinical assets into first-in-human studies or support their further development through the conduct of clinical pharmacology and mechanistic studies.
Through the application of scientific and medical training, the CRP participates in the following: the development, conduct and reporting of global clinical trials for new compounds, the implementation of global clinical trials, the reporting of adverse events as mandated by corporate patient safety; the review process for protocols, study reports, publications and data dissemination for products, new and updated labels, grant submissions and contracts, contracts with regulatory and other governmental agencies; and the outreach activities aimed at the external clinical customer community, including thought leaders.
The CRP is aware of and ensures that all activities of the medical team are in compliance with current local and international regulations, laws, guidance (e.g. FDA, ICH, and CPMP etc.), Good Clinical Practices (GCPs), company standards, Lilly policies and procedures, and the Principles of Medical Research and are aligned with the medical vision. In addition, the CRP works with the basic research scientists to plan pre-clinical studies, develop biomarker plans, and serves as a scientific and medical resource for study teams, departments, and others as needed.
Basic Qualifications
Medical Doctor (M.D.) or Doctor of Osteopathy (D.O.). Non-U.S. trained physicians must have completed education and training at a medical school that meets the requirements of the Liaison Committee on Medical Education (LCME). For the recognized list of foreign medical schools and the disapproved list, see PLA: Medical Licensing Information and Medical Education | MBC
Must be board eligible or certified in appropriate specialty/subspecialty or have completed the comparable level of post-medical school clinical training relevant to the country of hiring.
U.S. trained physicians must have achieved board eligibility or certification.
Foreign medical graduates in U.S. based jobs, who are not U.S. board eligible or certified may be hired directly for employment in the U.S. at the discretion of the Chief Medical Officer.
Additional Skills/Preferences
At least two (2) years of pharmaceutical industry experience, or similar, that provides adequate background relevant to clinical trial design and conduct of Phase 1 and Phase 2 studies (e.g., designing clinical programs, trials, and/or protocols, statistical/inferential methods, biomarkers/rating instruments, regulatory standards, safety assessment, investigator/site management).
Pharmaceutical company experience preferable.
Clinical and/or research experience in endocrinology, diabetes, obesity, cardiovascular, or renal research preferable.
Experience in Clinical Pharmacology preferable.
Additional scientific training or degree (M.S., Ph.D.) preferable.
Fluent in English; both written and verbal communications.
Demonstrated strong communication, interpersonal, organizational, teamwork and negotiation skills.
Demonstrated ability to influence others (both within teams and a matrix environment) in order to create a positive working environment.
Ability to engage in domestic and international travel to the degree appropriate to support the business of the team (approximately 10-15%).
Core Job Responsibilities
The primary responsibilities of the CRP are generally related to early phase clinical studies and late phase biopharmaceutical submission studies. The core job responsibilities may include those listed below as deemed appropriate by line management, as well as other duties as assigned.
Clinical Planning
Contribute to the development of the overall strategy and clinical plan for development of clinical compounds, focusing on studies required for product decision or regulatory submission.
Support preparation for first-in-human dosing studies including biomarker plans.
Support preparation of high-level plan for phase 2 and 3 studies for early phase and/or detailed biopharmaceutical plan to support submission.
Collaborate with other functional areas (Global Patient Safety, PK/PD, ADME, Statistics, Tailored Therapeutics organization) in the development of methods for assessing special clinical safety pharmacology studies.
Collaborate with other quantitative scientists (e.g., PK/PD, statistics, molecular epidemiology, ADME, modeling and simulations) to integrate study development and conduct with disease-progression and drug disease response models.
Contribute, as an integral member of the Exploratory Medicine and Pharmacology team, to global Phase 1 and 2 clinical studies as well as submission planning activities.
Work closely with discovery research scientists in the development of basic research strategies, clinical candidate compound selection, and pre-clinical development.
Work with Brand Team/Business Unit colleagues to provide appropriate market differentiation and regulatory support in the biopharmaceutical submission plan.
Clinical Research/Trial Execution and Support
Design and oversee implementation of all clinical pharmacology studies (e.g., single/multiple ascending dose, bioavailability, bioequivalence, drug-drug-interaction, food effect, renal impairment, hepatic impairment, mechanistic studies). Capabilities include understanding the unique aspects of conducting such studies in healthy volunteers and patient groups/special populations.
Apply fundamental concepts of clinical pharmacology and clinical pharmacokinetics to clinical pharmacology research.
Design and oversee implementation methods for development and biomarker qualification studies.
Design, create, and provide oversight for protocol development.
Support development of documents for the conduct of studies in collaboration with functions and operations staff and affiliates in accordance with GCP and local requirements.
Collaborate with local clinical research staff, statisticians, health outcomes research scientists and selected consultants and/or investigators in the development of protocols, and data collection requirements.
Participate in investigator identification and selection, in conjunction with the clinical pharmacology sourcing group.
Review and provide input to risk profiles and local informed consent documents as required, ensuring appropriate communication of risk to study subjects.
Provide oversight ensuring that operational team has documented the completion of administrative requirements for study initiation and conduct (i.e., ethical review board, informed consent, regulatory approval/notification) consistent with Good Clinical Practices (GCPs) and local laws and requirements.
Assist in planning process and participate in study start-up meetings and other activities to provide the appropriate training and information to investigators and site personnel.
Serve as resource to clinical trial managers, clinical research monitors, investigators and ethical review boards to address any questions or clarify issues arising during the conduct of study.
Understand and actively address the scientific information needs of all investigators and personnel.
Monitor patient safety during the conduct of studies and conduct the appropriate tracking and follow-up of adverse events, in alignment with global patient safety policies and procedures.
Implement and communicate appropriate pharmacovigilance actions as needed during conduct of the study in collaboration with global patient safety.
Provide appropriate oversight and partnership with Third Party Organizations to ensure successful study execution.
Scientific Data Dissemination/Exchange
Knowledge of and compliance with local laws and regulations, and global policies and procedures, compliance guidelines with respect to data dissemination and interactions with external health care professionals/customers.
Address the unsolicited scientific questions and information needs of external health care professionals according to guidelines above.
Participate in reporting of clinical trial data in Clinical Trial Registry activities.
Partner with NPP (New Product Planning) and scientific communications staff on publication strategy and process.
Prepare and present documentation of clinical trial results to corporate committees, regulatory agencies, and other external agencies.
Publish results of research projects as appropriate.
Consider, review, or develop pharmacoepidemiologic (quality of life, cost/effectiveness) and health economic aspects.
Support the planning of symposia, advisory board meetings, and other meetings with health care professionals.
Participate in data analysis, development of scientific data dissemination, and preparation of final reports and publications for clinical pharmacology-biopharmaceutical trials.
Provide clinical reports for local and international regulatory purposes.
Regulatory Support Activities
Support and assist in the preparation of regulatory reports, including the medical sections of the IND and Investigator Brochure, preparation of FDA advisory committee regulatory hearings and label discussions, and communications and resolution of regulatory issues, including regulatory response.
People Management and Development:
Develop and retain a scientifically excellent, innovation-minded, highly capable workforce with strong exploratory medicine experience.
Build an organizational culture that fosters inclusion and innovation, continual improvement, and with an external understanding and awareness.
Develop an organizational talent base that demonstrates judgment-based risk taking and decision making.
Business customer support (pre and post launch support)
Contribute to the development of medical strategies to support brand commercialization activities by working closely with business unit, New Product Planning, and business development.
Understand the scientific information needs of all Development customers (business unit, payers, patients, health care providers).
Establish and maintain contact with external experts and opinion leaders; maintain a credible scientific expertise to facilitate these contacts.
Support business-to-business and business-to-government activities as medical expert.
Contribute actively on an ongoing basis to the strategic planning for the brand.
Become familiar with market archetypes and potential influence on the medical interventions for the product.
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
$198,000 - $389,400
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
$112k-141k yearly est. Auto-Apply 13d ago
Sr. Plastic Surgery Sales Representative - Columbus, OH - Johnson & Johnson MedTech - Aesthetics and Reconstruction
J&J Family of Companies 4.7
Columbus, OH job
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 - Surgeons (Commission)
**Job Category:**
Professional
**All Job Posting Locations:**
Cincinnati, Ohio, United States of America, Columbus, Ohio, United States
**Job Description:**
We are searching for the best talent for Senior Plastic Surgery Sales Representative to be in Columbus, OH.
**About Surgery**
Fueled by innovation at the intersection of biology and technology, we're developing the next generation of smarter, less invasive, more personalized treatments.
Are you passionate about improving and expanding the possibilities of surgery? Ready to join a team that's reimagining how we heal? Our Surgery team will give you the chance to deliver surgical technologies and solutions to surgeons and healthcare professionals around the world. Your contributions will help effectively treat some of the world's most prevalent conditions such as obesity, cardiovascular disease and cancer. Patients are waiting. Your unique talents will help patients on their journey to wellness. Learn more at *******************/medtech
The **Sr. Surgery Plastic Surgery Sales Rep.** position at Mentor Worldwide is an excellent opportunity to make an impact in the sales organization. The SPSR will support the Location geography by expanding the sales of Mentor products and to convert competitive products in a manner that is commensurate with company policy and sales direction. Specific responsibilities include:
**Develop Customers/Account Management**
+ Demonstrates effective product differentiation selling skills and business development by providing a consultative sales approach to the customer's business, developing effective pre-call plans, assessing customer needs, handling objections, presenting visual aids, closing, and following-up.
+ Builds strong relationships and holds customers accountable to commitments; high level of customer interaction.
+ Proficient in managing account growth; strong knowledge of business environment and products (educates the customer, seeks to understand customer circumstances, needs and concerns); motivates customers to become product advocates; builds strategic working relationships; ability to develop and service KOL's; allocate marketing programs.
+ Ability to proficiently position the Mentor portfolio for both augmentation and reconstruction settings.
**Productive and Efficient Territory Management** :
+ Meets productivity goals across product portfolio.
+ Manages and executes across multiple product call points including private practice, surgery centers, and hospitals. Demonstrates ability to assess territory metrics to develop and implement territory business plans.
+ Implements and promotes marketing programs in private practice setting.
+ Meets sales training requirements set forth by senior leadership. Meets additional administrative requirements and timelines set by Regional Manager. Manages and completes all consignment audits before deadlines. Effectively maintains territory within Regional Travel and Budget.
+ Proficiency of market knowledge; technical fluency across Mentor Portfolio and competitive product portfolios; knowledge of breast anatomy; demonstrates an expertise in supporting studies/material. Understands how individual tactics support the overall strategy and executes the marketing plan across the product portfolio. Ability to articulate strategy to customers, management and team members.
**Requirements** :
The following listed requirements need to be met at a minimum level to be considered for the job:
+ Bachelor's degree or equivalent years of experience in Aesthetics Industry / Medical Device Sales
+ 4 or more years of medical sales experience and/or training
+ Surgical Sales Experience Preferred
+ Knowledge of clinical, surgical techniques and procedures, and medical terminology preferred
+ Preferred Skills/Qualification
+ Ability to identify decision makers and influence decisions
+ Ability to manage and prioritize workload, multi-task and manage a diverse mix of issues, responsibilities and challenges
+ Excellent communication skills and presentation skills
+ Ability to manage budgets, expenses and execute plans
+ Strong computer skills
+ Ability to function effectively in a high-performance team. Exhibits a high degree of flexibility in adapting to a rapidly changing environment.
+ Strong organizational and prioritization skills.
+ Ability to communicate scientific/clinical features and benefits of a product
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.
At Johnson & Johnson, we want every candidate to feel supported throughout the hiring process. Our goal is to make the experience clear, fair, and respectful of your time.
Here's What You Can Expect
+ Application review: We'll carefully review your CV to see how your skills and experience align with the role.
+ Getting to know you: If there's a good match, you'll be invited to complete a short-recorded video interview, giving you the chance to share more about yourself. If successful, a recruiter will also reach out by phone to walk you through the process and answer any questions.
+ Interviews with the team: If you move forward, you'll meet with the hiring manager (and possibly others on the team) in one or two interview rounds, depending on the role.
+ Staying informed: We know waiting can be hard, so our recruitment team will keep you updated and make sure you know what to expect at each step.
+ Final steps: For successful candidates, you will need to complete country-specific checks before starting your new role. We will help guide you through these.
At the end of the process, we'll also invite you to share feedback in a short survey - your input helps us continue improving the experience for future candidates. Thank you for considering a career with Johnson & Johnson. We're excited to learn more about you and wish you the best of luck in the process! #RPONA
**Required Skills:**
**Preferred Skills:**
Account Management, Analytical Reasoning, Business Behavior, Collaborating, Cultural Competence, Customer Analytics, Customer Centricity, Healthcare Trends, Learning Agility, Market Knowledge, Market Research, Oracle Customer Data Management (CDM), Problem Solving, Sales, Solutions Selling, Sustainable Procurement, Vendor Selection
**The anticipated base pay range for this position is :**
$58,000-$94,000
Additional Description for Pay Transparency:
Employees and/or eligible dependents may be 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. Employees may be eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)). Employees are eligible for the following time off benefits: Vacation - up to 120 hours per calendar year Sick time - up to 40 hours per calendar year Holiday pay, including Floating Holidays - up to 13 days per calendar year Work, Personal and Family Time - up to 40 hours per calendar year For additional general information on Company benefits, please go to: - ********************************************* This job posting is anticipated to close on February 3, 2026. The Company may however extend this time-period, in which case the posting will remain available on *************************** to accept additional applications.
$58k-94k yearly 7d ago
Automation Maintenance Technician Night Shift 12 Hours (6PM to 6AM)
Amgen 4.8
Amgen job in New Albany, OH
**Join 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.
Automation Maintenance Technician (6PM to 6AM)
**What you will do**
Let's do this. Let's change the world. At Amgen, we are committed to being science-based and follow a continuous learning approach to advancing science, driving discovery, and igniting innovation that works to help reduce disease. It is in this context that we endorse an inclusive and diverse workforce that helps drive scientific innovation and problem solving, leading to better scientific solutions that benefit both patients and society.
Based in New Albany, Ohio, the site of Amgen's new advanced product assembly and packaging plant. In this role you will provide technical engineering support on all system/equipment optimization strategies, upgrades, replacements, and modifications. You will evaluate and determine if utility systems, process maintenance, instrumentation/ calibration/electrical systems and technical cleaning systems are maintained in compliance with all applicable industry standards, regulatory standards and FDA standards in the Inspection and Packaging area.
The work schedule for this role will be a first shift schedule (Monday through Friday, approximately 6:30 am to 3:00 pm) for 1-3 months and then move to a 12 hour PM 2-2-3 shift schedule. As the facility moves into operation, the successful incumbent will be expected to join a shift team structure working to support coverage across Amgen's 24-hour operations. These shift structures can be a great opportunity to better support individual work/life priorities in Non-Standard Shifts structure.
**Responsibilities:**
+ Take part in the coordination of tech support on engineering, regulatory, compliance, calibration, quality, microbial/environmental, technical cleaning, validation, electrical and process automation issues.
+ Assist during regulatory agency inspections. Provide technical support in response to the FDA and other regulatory agencies.
+ Complete advanced maintenance activities or operate and monitor sophisticated plant support equipment in accordance with CFRs, cGMPs, SOPs, job plans and Amgen policies. Investigate complex issues or problems through the mentorship of experienced staff.
+ Assist the team with maintaining an up-to-date working spare parts inventory system for the equipment/systems the team.
+ Evaluate the current maintenance procedures and assist in the changes to optimize the maintenance program, trouble shoot and repair equipment/system failures.
+ Interpret and review utility, process system/ equipment, plumbing, ductwork plans, architectural, and HVAC P&ID's.
+ Support Operations in Non-Standard shifts that includes weekends and/or holidays as determined by business.
**What we expect of you**
We are all different, yet we all use our unique contributions to serve patients. The automation professional we seek will possess these qualifications:
**Basic Qualifications:**
Bachelor's degree
Or
Associate's degree and 4 years of Technical Engineering experience
Or
High school diploma / GED and 6 years of Technical Engineering experience
**Preferred Qualifications:**
+ Educational background in Mechatronics, Computer Science, Electronic Engineering Technology, Computer Engineering or Electrical Engineering
+ Understanding in PLC, Computer Serialization, Packaging Equipment, Inspection System
+ SCADA/PLC Control System experience in Pharmaceutical, Medical Device or Biotechnology Industry
+ Other Automated Control Systems to be supported are: Siemens and Rockwell HMI's, Cognex Vision System, Sensor and Systech Serialization
+ Experience with automation system hardware and software support, including installation
+ Excellent organizational, project management, problem solving and technical writing capability
+ Strong communication: verbal / written, collaboration, influencing and facilitation
+ MS Office: Word, Excel, Power Point
**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.
**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.
$50k-67k yearly est. 4d ago
Design + Human Factors Engineering Senior Director
Eli Lilly and Company 4.6
Remote job
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
$163.5k-264k yearly Auto-Apply 52d ago
Regulatory Affairs Senior Director - Global Regulatory Leader - Obesity
Amgen 4.8
Remote Amgen job
Career CategoryRegulatoryJob Description
HOW MIGHT YOU DEFY IMAGINATION?
You've worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? 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, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role.
Regulatory Affairs Senior Director - Global Regulatory Leader - Obesity
Live
What you will do
Let's do this. Let's change the world. In this vital role you will support products in the Obesity Therapeutic Area. Global Regulatory Affairs (GRA) provides global regulatory leadership, expertise, and execution for the development, registration, and life cycle management of all Amgen molecules.
To lead GRTs within Amgen's GRAAS organization
To independently develop a comprehensive regulatory strategy for one or more high complexity programs, typically in late-stage development and/or with multiple indications, that takes into account worldwide regulatory requirements to drive product development, global registration, achievement and maintenance of desired regional labeling, and effective regulatory agency interactions
To provide Regulatory leadership to cross-functional teams for high complexity programs with major Regulatory deliverables such as global original marketing applications
Develop and implement global regulatory product strategies designed to achieve approval and target product labeling for prioritized assets in late development with highly complex development programs
Represent GRA on the product team and other key commercialization governance bodies, guide and influence the organization to achieve Regulatory objectives
Independently develop the Global Regulatory Strategic Plan and provide regulatory input into the product's Global Strategic Plan. Obtain input from the GRT members to develop a global regulatory strategy which supports product development, registration and lifecycle maintenance. Identify and communicate regulatory risks
Provide regulatory direction in the development of the core data sheet to align commercial objectives in the context of available and expected scientific data, regulatory guidance, and precedent
Independently lead the planning and implementation of global regulatory filings (eg, clinical trial applications, marketing applications, label extensions)
Ensure consistency of evidence-based global product communication (eg, regulatory submission documents)
Monitor and assess impact of relevant global regulations, guidance, and current regulatory environment; advise product teams and GRT on implications of pertinent changes
Assess regulatory mechanisms to optimize product development (eg, expediting FIH studies, Orphan Drug Designation, Fast Track Designation, conditional /accelerated approval, compassionate use, and pediatric plan) and ensure appropriate incorporation into the global regulatory strategy
Clearly and succinctly communicate regulatory strategies, associated risks, mitigations, and contingencies to the organization such that the probability of regulatory success and potential outcomes are well understood
Lead GRTs and product teams in formal and informal communications with regulatory agencies
Lead the approach and strategy for formal interactions with Regulatory agencies, especially those which could impact the global product strategy
Represent Amgen Regulatory on external partnership teams at the product level
Lead regulatory process improvements and initiatives
Win
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:
Doctorate degree and 5 years of regulatory experience in biotech or science
OR
Master's degree and 8 years of regulatory experience in biotech or science
OR
Bachelor's degree and 10 years of regulatory experience in biotech or science
Preferred Qualifications:
Contemporary obesity experience desired
Demonstrated ability to lead regulatory aspects of highly complex programs in late development
Previous experience leading a Regulatory team for submission and approval of an original marketing application and/or major new indication supplemental application
Ability to lead and build effective teams
Strong communication skills - both oral and written
Ability to understand and communicate scientific/clinical information
Ability to anticipate and mitigate against future strategic issues and uncertainties
Ability to resolve conflicts and develop a course of action
Cultural awareness and sensitivity to achieve global results
Planning and organizing abilities
Able to prioritize and manage multiple activities
Ability to make complex decisions and solve problems
Ability to deal with ambiguity
Organizational savvy
Negotiation skills
Thrive
What you can expect of us
As we work to develop treatments that take care of others, we also work to care for our teammates' professional and personal growth and well-being.
Amgen offers a Total Rewards Plan comprising 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 including:
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 and bi-annual company-wide shutdowns
Flexible work models, including remote work arrangements, where possible
Apply now
for a career that defies imagination
Objects in your future are closer than they appear. Join us.
careers.amgen.com
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
Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
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.
#Obesity
.
Salary Range
216,805.00 USD - 259,624.00 USD
$100k-131k yearly est. Auto-Apply 60d+ ago
United States Regulatory Professional- Obesity and Related Conditions
Amgen 4.8
Remote Amgen job
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.
OR
United States Regulatory Professional (USRP)- Obesity and Related Conditions TA
Live
What you will do
Let's do this! Let's change the world!
Amgen is seeking a United States Regulatory Professional (USRP) supporting products in the Obesity and Related Conditions Therapeutic Area (TA). Global Regulatory Affairs (GRA) provides global regulatory leadership, expertise, and execution for the development, registration, and lifecycle management of Amgen molecules. In this product-facing role, you will support the creation and submission of regulatory documents under the supervision of a more experienced regulatory lead.
The USRP provides operational support for U.S. regulatory execution by coordinating submission deliverables, maintaining compliant documentation, and partnering cross-functionally to enable effective health authority engagement.
Win
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.
Key responsibilities
Coordinate and execute U.S. regulatory submissions in compliance with Amgen corporate standards and FDA requirements.
Drive submission readiness by coordinating inputs, tracking timelines, and ensuring deliverables are complete, accurate, and submitted on time.
Maintain regulatory documentation and records, including preparation, delivery, and electronic archiving of submission content and agency communications.
Create and maintain product regulatory history documentation (e.g., IMR, as applicable).
Support U.S. labeling activities, including review of source text to enable U.S. labeling updates.
Support review of promotional and non-promotional materials as applicable and in accordance with internal requirements.
Coordinate and QC briefing documents and other materials for meetings with regulatory agencies.
Under general supervision, support FDA interactions and act as a point of contact as appropriate to fulfill product-specific obligations.
Support responses to health authority questions by coordinating inputs, tracking actions, and ensuring document readiness.
Collate and communicate regulatory information across regulatory colleagues and cross-functional teams; provide timely updates on U.S.-specific considerations.
Maintain awareness of emerging U.S. legislation, guidance, and regulatory policy; escalate and disseminate relevant updates to appropriate stakeholders.
Participate in cross-functional and team governance (e.g., GRT support including agendas/minutes) as needed.
Basic Qualifications:
Master's degree in biology, life science, health science, or regulatory science with a biology curriculum
OR
Bachelor's degree in a science discipline (biology, life science, health science) and 2 years of directly related experience
OR
Associate's degree in a science discipline (biology, life science, health science) and 6 years of directly related experience
OR
High school diploma / GED in a science discipline (biology, life science, health science) and 8 years of directly related experience
Preferred Qualifications:
Experience in a regulated industry (e.g., biotech/pharma, medical device, clinical research, healthcare)
Experience supporting programs in Obesity, Diabetes, or related metabolic diseases through scientific or clinical work
Strong written and oral communication skills
Strong organizational skills; ability to manage multiple activities, timelines, and stakeholders
Demonstrated attention to detail and document quality mindset
Ability to identify, communicate, and escalate risks/issues appropriately
Experience with document management and archiving practices in a regulated setting
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
88,347.00 USD - 110,633.00 USD
$72k-99k yearly est. Auto-Apply 2d ago
Field Clinical Specialist - Shockwave - Fort Worth, Texas - Remote
Johnson & Johnson 4.7
Remote or Fort Worth, TX job
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:
Fort Worth, Texas, United States
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. You must be located in the Fort Worth area.
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.
Qualifications
* 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.
Pay Transparency:
Additional Information:
* The base pay range for this position is $100,000.
* The Company maintains a highly competitive sales incentive compensation program. Under current guidelines, this position is eligible for participation in this program in accordance with the terms of the applicable plan.
* This position is eligible for a car allowance through the Company's Fleet program
* Employees and/or eligible dependents may be 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.
* Employees may be eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)).
* Employees are eligible for the following time off benefits:
* Vacation - up to 120 hours per calendar year
* Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington - up to 56 hours per calendar year
* Holiday pay, including Floating Holidays - up to 13 days per calendar year
* Work, Personal and Family Time - up to 40 hours per calendar year
* Additional information can be found through the link below. *********************************************
The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.
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.
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
$100k yearly Auto-Apply 9d ago
Senior Associate - Regulatory Affairs (US-Remote)
Amgen 4.8
Remote Amgen job
Career CategoryRegulatoryJob Description
HOW MIGHT YOU DEFY IMAGINATION?
You've earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge you've worked hard to acquire and the passion you already have. 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, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role.
Senior Associate - Regulatory AffairsLiveWhat you will do
Let's do this. Let's change the world. In this vital role you will assist the US Regulatory Leads and the Global Regulatory Team (GRT) in the Regulatory Affairs organization.
To coordinate and execute US regulatory submissions under the direction of the US Regulatory Lead in compliance with corporate standards and regulatory requirements.
To manage and execute the preparation, delivery, and electronic archiving of documentation for inclusion in US regulatory submissions
To assist the Global Regulatory Lead to manage GRT interactions
Key responsibilities include:
Assist US Regulatory Lead to support local regulatory activities (e.g. IND submissions and agency meetings)
Provide and maintain CTA/MA documentation support (e.g. initial filings, amendments, and periodic reports) in collaboration with US Regulatory Lead
Create and maintain product regulatory information and history documents through Amgen systems
Appropriately archive regulatory documents and agency communications
Collaborate with CRO's / partners to support site initiation
Complete regulatory forms to support agency communications
Participate in GRT to support execution of regulatory strategy
Coordinate QC of regulatory documentation (e.g. briefing materials)
Provide primary authorship to routine regulatory correspondence (e.g. annual reports, investigator packages)
Assist in template development and maintenance
Respond to specific requests from and communicate relevant issues to GRT
Actively support regulatory compliance
WinWhat 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 self-starter with these qualifications.
Basic Qualifications:
Master's degree
Or
Bachelor's degree and 2 years of Regulatory Affairs experience
Or
Associate's degree and 6 years of Regulatory Affairs experience
Or
High school diploma / GED and 8 years of Regulatory Affairs experience
Preferred Qualifications:
Strong communication skills - both oral and written
Ability to understand and communicate scientific/clinical information
Ability to collaborate with team members to tackle problems and develop a course of action
Cultural awareness and sensitivity to achieve global results
Planning and organizing abilities
Able to prioritize and balance multiple activities
Ability to deal with ambiguity
Ability to influence others
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
88,347.00 USD - 110,633.00 USD
$79k-106k yearly est. Auto-Apply 2d ago
Sr. Field Clinical Engineer - Shockwave Medical
Johnson & Johnson 4.7
Remote or Santa Clara, CA job
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 Sr. Field Clinical Engineer - Shockwave Medical to join our team. This role is fully remote with 80% travel.
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 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 Cardiology or surgical procedures in a cardiovascular Lab.
* 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 Schedule, Research and Development, Study Management
The anticipated base pay range for this position is :
$106,000.00 - $170,200.00
Additional Description for Pay Transparency:
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)).
For additional general information on Company benefits, please go to: - *********************************************
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 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 period10 days
Volunteer Leave - 32 hours per calendar year
Military Spouse Time-Off - 80 hours per calendar year
$106k-170.2k yearly Auto-Apply 5d ago
Senior Director Technology Leader Surgery R&D
Johnson & Johnson 4.7
Cincinnati, OH job
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:
Technology Product & Platform Management
Job Sub Function:
Technical Product Management
Job Category:
People Leader
All Job Posting Locations:
Cincinnati, Ohio, United States of America, Raritan, New Jersey, United States of America
Job Description:
Johnson & Johnson Medical Devices is transforming to a digital-first Med Tech business. With great innovation, market opportunities, and an audacious strategic intent, we are combining robotic assisted surgery platforms, connected devices, surgical instrumentation, advanced imaging, enhanced surgical visualization, surgical efficiency solutions, and OR workflow integration for the next generation Med Tech platform. As a result, we will also create new surgical insights, drive supply chain innovation, leverage cloud infrastructure, integrate cyber security, interface with hospital EMRs, and elevate our patient pathway franchise digital solutions.
The Technology Leader for Surgery R&D is a visionary leader responsible for setting and executing the technology agenda within the surgical research and development function. This role is pivotal in driving the digital transformation of surgical solutions, integrating emerging technologies, and fostering a culture of innovation to deliver next-generation products and platforms that improve patient outcomes and operational efficiency.
Major Duties & Responsibilities
* Strategic Leadership: Develop and implement a comprehensive technology strategy aligned with the organization's R&D goals, anticipating future trends and disruptive technologies in the surgical and healthcare landscape.
* Digital Transformation: Champion the adoption of digital tools, data analytics, artificial intelligence, and machine learning to accelerate R&D cycles, enhance surgical device functionality, and enable personalized medicine.
* Innovation Management: Lead multidisciplinary teams to identify, evaluate, and implement innovative solutions, including robotics, IoT, digital surgery platforms, and advanced imaging technologies.
* Collaboration: Build partnerships with clinical, academic, and industry stakeholders to foster open innovation and ensure the R&D pipeline leverages the latest scientific and technological advances.
* Technology Governance: Establish robust processes for technology evaluation, risk assessment, and compliance with regulatory and cybersecurity standards in the healthcare sector.
* Talent Development: Mentor and develop a high-performing technology team, promoting continuous learning and a growth mindset in a rapidly evolving R&D environment.
* Operational Excellence: Oversee the effective deployment of digital platforms and tools that improve process efficiency, data integrity, and collaboration across global R&D sites.
Other Duties
* Contribution to broader J&J Technology & J&J MedTech Technology strategies.
* Contribution to the progression of DE&I and talent agendas for J&J Technology & J&J MedTech Technology organizations.
* Support Business Development & Innovation Partnership - assess strategic fit of partners and technology
* Change management across J&J MedTech and JJT related to our Digital Transformation and High Performing Team model.
Required Qualifications
Required Minimum Education: Master's Degree or equivalent through experience
Required Years of Related Experience: 15 Years
Required Knowledge, Skills and Abilities:
* Deep understanding of the digital transformation landscape, including AI/ML, robotics, cloud computing, data security, and digital health ecosystems.
* Strong knowledge of regulatory requirements (e.g., MDR, FDA, GDPR) and standards relevant to medical technology and digital health.
* Excellent communication, stakeholder management, and change leadership skills.
Percentage Traveled:
25%
Type of Travel Required:
Domestic
International
People Management Experience:
Yes
Required Years of People Management Experience:
10
Preferred Qualifications
Preferred Minimum Education: Advanced degree (Master's or PhD) in Engineering, Computer Science, Biomedical Sciences, or related field or equivalent through experience
Preferred Knowledge, Skills and Abilities:
* Visionary thinking and ability to anticipate industry shifts
* Strong analytical, problem-solving, and decision-making abilities
* Entrepreneurial mindset with a passion for innovation
* Ability to influence and inspire diverse teams
* Commitment to ethical standards and patient-centricity
* Experience with Cloud Technologies, Data Analytics and ML/AI
* Application of ML/AI or Intelligent Automation to drive business outcomes and efficiency.
* Previous involvement in business transformation through digital / technology; change management
* Experience working in Product Based Operating Models
* Member of business leadership team
Direct Reports: 4
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, Cost Management, Developing Others, Fact-Based Decision Making, Human-Computer Interaction (HCI), Inclusive Leadership, Industry Analysis, Leadership, People Performance Management, Performance Measurement, Policy Development, Product Development, Product Strategies, Project Management Methodology (PMM), Research and Development, Software Development Management, Strategic Supply Chain Management, Tactical Planning
The anticipated base pay range for this position is :
$178,000.00 - $307,050.00
Additional Description for Pay Transparency:
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 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 period10 days
Volunteer Leave - 32 hours per calendar year
Military Spouse Time-Off - 80 hours per calendar year
$98k-123k yearly est. Auto-Apply 14d ago
Director - Clinical Research Scientist - Immunology/Gastroenterology Development
Eli Lilly and Company 4.6
Remote job
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.
The GI Therapeutic Area within Lilly Immunology Development is focused on developing new therapies for patients with gastrointestinal diseases. The GI immunology development team is seeking a motivated clinical research scientist that is passionate about drug development within gastroenterology. The candidate must have extensive drug development experience in mid-to-late phase trials. They will engage in various trial related activities including but not limited to the development, conduct and reporting of global clinical trials in support of registration and commercialization of new therapies; the reporting of adverse events; the drafting and review process for protocols, study reports, publications; engagement with global regulatory authorities and other governmental agencies; outreach medical activities including thought leaders engagement.
Key Objectives/Deliverables
The primary responsibilities of the Development CRS are generally related to late-phase and marketed compounds. The core job responsibilities may include those listed below as deemed appropriate by line management, as well as other duties as assigned.
Clinical Planning: product lifecycle plan, clinical strategies, development plans and study protocol design. Provide subject matter expertise and keep updated with the pre-clinical and clinical data relevant to the molecule
Clinical Trial Execution and Support: Plans, collaborates on and reviews scientific content of clinical documents such as protocols, informed consent documents, final study reports, and submissions. Supports the monitoring of patient safety during study and engages in the global product safety reviews. Cross function collaboration with clinical trial teams in the design, conduct and reporting of mid to late phase clinical trials. Conduct study start-up meetings, investigator meetings and other activities to provide the appropriate training and information to investigators and site personnel.
Scientific Data Dissemination/Exchange: engage in reporting of clinical trial data in Clinical Trial Registry activities. Support the planning of symposia, advisory board meetings, and other meetings with health care professionals. Establish and maintain collaborations and relationships thought leaders. Support clinical trial data analysis and publications.
Regulatory Support Activities: Provide medical expertise to regulatory scientists and support regulatory strategy.
Scientific and Technical Expertise and continued development: Acts as scientific consultant and protocol expert for clinical study team members and others in medical.
Minimum Requirements
An advanced health/medical/scientific (for example, in Pharmacology, physiology, microbiology) or related graduate degree such as, PharmD, PhD
3+ years of clinical development experience, including mid-to-late-stage development
Additional Skills/Preferences
Demonstrated ability to balance scientific priorities with business priorities with examples of successful leadership skills
Demonstrated strong communication, interpersonal, teamwork, organizational, and negotiation skills
Previous GI drug development experience
Pediatric drug development experience
Oral/written communication/listening skills are essential
Strong relationship-building and interaction skills with peers and management
Preferred location is Indianapolis, though remote arrangements may be considered
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
$177,000 - $338,800
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
$93k-127k yearly est. Auto-Apply 13d ago
Data Scientist
Johnson & Johnson 4.7
Brunswick, OH job
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:
Data Analytics & Computational Sciences
Job Sub Function:
Data Science
Job Category:
Scientific/Technology
All Job Posting Locations:
New Brunswick, 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
We are searching for the best talent for Data Scientist
Purpose:
As a Data Scientist in Global Finance Data Science Team: You will be contributing to a high standard delivery of data science driven predictive financial statements - consumed by senior leadership. You will work in a global team of Data Scientists, Data Engineers and Machine Learning Engineers to advance the Data Science and AI roadmap for J&J's Global Finance function. You will assist in delivering value-added insights and analytics to our finance and business leaders, reduce manual work through automated reasoning, and enhance user-experience.
You will be responsible for:
You will mainly focus on advancing and broadening the capabilities of our Predictive Financial Statements, plugging results into SAP Analytics Cloud reporting - where most stakeholders go for corporate internal financial statements. Your job will also include aligning finance and business needs, validation of data from different source systems, and data reconciliation. You will mainly be required to create new models and leverage or extend the use of existing models for other financial statements. You will also enhance existing models for accuracy, speed and cost.
You will be involved in data science projects across their lifecycle, from design to production and adoption by end users. This will include creating proof-of-concepts for new project, data science model development, data pipeline development and production deployment. The capabilities developed will include forecasting, descriptive analytics, data visualization, GenAI and decision support. This role will involve understanding the needs of business stakeholders and advocating the merits of data-driven analytics to provide viable solutions.
You will be responsible for:
Adopting a highly successful forecasting processes and technologies and delivering predictive financial statements monthly.
Modeling the impact of future events to enhance forecast accuracy.
Developing data pipelines for large datasets sourced from financial systems and automating data science processes.
Documenting and aligning model changes within the team and stakeholders.
Communicating insights to stakeholders leveraging data visualization tools.
Monitoring model performance, and continuously improving existing models.
Collaborating with finance, commercial leaders, technology teams, and external partners to deliver end-to-end solutions, ensuring compliance and risk management.
Advocating for data-driven insights and data science methods across the organization and managing compliance adherence.
Qualifications / Requirements:
Minimum of 2 years of Data Science/ AI experience in an industry setting is required, preferably in a Finance or Healthcare setting.
Minimum of a Bachelors degree is required, preferably in Science, Economics, Business Analytics, Data Science, Finance, Computer Science, Engineering or any other quantitative or STEM discipline.
Technical Requirements
Proficient in Python/R/Alteryx programming and experienced with Data Science Cloud platforms like AWS and Databricks or Domino.
Experienced using finance data and SAP HANA data tables is a plus.
Proficient in interpreting data sources and correlating to financial metrics.
Able to work independently and under time pressure to deliver results, investigating and solving data issues in an explainable way.
Skilled in data visualization and dashboarding using Tableau or PowerBI.
Knowledgeable in statistical techniques and concepts, such as regression, properties of distributions, and statistical tests.
Strong data analytics skills and attention to detail.
Other:
The position will be located in New Brunswick, NJ and may require up to 10% travel.
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.
#LI-Hybrid #JNJDataScience
Required Skills:
Artificial Intelligence (AI), Python (Programming Language)
Preferred Skills:
Advanced Analytics, Analytical Reasoning, Business Intelligence (BI), Business Writing, Coaching, Collaborating, Communication, Data Analysis, Data Compilation, Data Privacy Standards, Data Savvy, Data Science, Data Visualization, Econometric Models, Execution Focus, Technical Credibility, Technologically Savvy, Workflow Analysis
The anticipated base pay range for this position is :
The anticipated base pay range for this position is $89,000 to $143,750 USD.
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. *********************************************
$89k-143.8k yearly Auto-Apply 4d ago
Associate R&D Mechatronic Engineer
Johnson & Johnson 4.7
Cincinnati, OH job
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 Product Development
Job Sub Function:
R&D Electrical/Mechatronic Engineering
Job Category:
Scientific/Technology
All Job Posting Locations:
Cincinnati, Ohio, United States of America
Job Description:
Ethicon's Robotics & Digital Solutions business, part of Johnson & Johnson MedTech, is recruiting for an Associate R&D Mechatronic Engineer, located in Cincinnati, OH.
Robotics and Digital Solutions, is part of Johnson & Johnson Med Tech. At Johnson & Johnson Robotics and Digital Solutions, we're changing the trajectory of health for humanity, using robotics to enhance healthcare providers' abilities and improve patients' diagnoses, treatments, and recovery times. Johnson & Johnson Robotics was established in 2020 with the integration of Auris Health, Verb Surgical, C-SATS, and Ethicon. It comprises three key med-tech platforms: Flexible Robotics (MONARCH ), Surgical Robotics (OTTAVA™), and Digital Solutions. Join our collaborative teams in the Bay Area (Santa Clara) and Cincinnati. You'll collaborate on breakthrough medical technologies that unite multiple subject areas to build a connected digital ecosystem that advances medical professionals' skills and improves patient outcomes.
As an Associate R&D Mechatronic Engineer, you will play a critical role in designing, developing, and optimizing test systems for cutting-edge robotic medical devices. You'll work closely with cross-functional teams to create common test platforms, analyze performance data, and ensure our devices meet rigorous standards for safety and effectiveness.
Key Responsibilities:
Develop software and hardware systems and test methods to evaluate the performance of robotic instruments.
Support the design of product concepts quickly and effectively via prototype builds, laboratory testing, and/or computer simulations.
Generate, process, analyze advanced engineering data to meet design requirements.
Participate in detailed reviews of designs, test methods, requirements, and effectively communicate technical information in written/verbal forms.
Collaborate with other hardware and software engineers to align and set functional best practices for test method development.
Support effective test execution management, data collection and reporting through coordination and collaboration with existing resources.
All responsibilities listed may not be assigned and other responsibilities may be assigned.
Qualifications
Required Knowledge/Skills, Education, And Experience:
Bachelor of Science in Software Engineering, Mechanical Engineering, Biomedical Engineering, or related science/engineering field.
1 year minimum of product development/ design experience.
Experience programming in Python.
Experience working in a Linux environment.
Able to assist with engineering investigations, problem solving, root cause, prototype rework, and component modification.
Effective communication, collaboration, and teaming skills with ability to present technical information to engineering team.
Data analysis experience.
Up to 10% domestic and international travel may be required, including overnight stays.
Ability to work in Cincinnati, Ohio.
Preferred Knowledge/Skills, Education, And Experience:
Experience using or developing with ROS2, databases (Postgres or MySQL), and cloud platforms.
Familiarity with version control and code management tools (git, bitbucket).
Vision inspection and processing using Cognex or OpenCV.
Basic mechanical design and analysis skills, including an understanding of mechanism design and machine elements.
Able to provide positive and constructive feedback to teammates on product concepts and designs.
Organized with creative with analytical and problem-solving skills; Able to work independently under general supervision.
Able to set and prioritize goals with general guidance from management.
Experience working on a project team with demonstration of encouraging and inclusive behaviors.
Knowledge of component manufacturing processes (injection molding, machining, stamping, etc.), DFM/A, and Design to Cost.
Working knowledge of design controls, design plans, and verification/validation, preferably as they apply within a regulated industry.
Systems-based design experience, including integration of cross-disciplinary technologies (e.g., mechanical, electrical, controls, software).
Experience in the design, development, and commercialization of medical devices with an understanding of their application in surgical procedures.
Experience in the verification of medical devices according to regulatory standards, including FDA requirements.
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.
Employees and/or eligible dependents may be 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.
Employees may be 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.
Employees are eligible for the following time off benefits:
Vacation - up to 120 hours per calendar year
Sick time - up to 40 hours per calendar year
Holiday pay, including Floating Holidays - up to 13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
For additional general information on Company benefits, please go to: *********************************************
This job posting is anticipated to close on 01/20/26. The Company may however extend this time-period, in which case the posting will remain available on *************************** to accept additional applications.
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:
Data Analysis, Linux Environments, Mechatronics, Python (Programming Language)
Preferred Skills:
Assembly Operations, Calibration Procedures, Customer Service, Electrical Engineering, Execution Focus, Goal-Oriented, Process Oriented, Project Management, Report Writing, Research and Development, Robotic Automation, SAP Product Lifecycle Management, Smart Systems, Technical Research, Technical Troubleshooting, Technical Writing, Technologically Savvy, Versatility
The anticipated base pay range for this position is :
The anticipated base pay range for this position is $76,000.00 to $121,900.00
Additional Description for Pay Transparency:
Zippia gives an in-depth look into the details of Amgen, including salaries, political affiliations, employee data, and more, in order to inform job seekers about Amgen. The employee data is based on information from people who have self-reported their past or current employments at Amgen. The data on this page is also based on data sources collected from public and open data sources on the Internet and other locations, as well as proprietary data we licensed from other companies. Sources of data may include, but are not limited to, the BLS, company filings, estimates based on those filings, H1B filings, and other public and private datasets. While we have made attempts to ensure that the information displayed are correct, Zippia is not responsible for any errors or omissions or for the results obtained from the use of this information. None of the information on this page has been provided or approved by Amgen. The data presented on this page does not represent the view of Amgen and its employees or that of Zippia.
Amgen may also be known as or be related to AMGEN INC, Amgen, Amgen Inc, Amgen Inc. and Applied Molecular Genetics (1980–1983).