Export Customer Service Analyst
Somerset, NJ jobs
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at *******************
Job Function:
Customer Management
Job Sub Function:
Customer Service Operations
Job Category:
Professional
All Job Posting Locations:
Shepherdsville, Kentucky, United States of America, Somerset, New Jersey, United States of America, Titusville, New Jersey, United States of America
Job Description:
About Innovative Medicine
Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.
Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at *******************/innovative-medicine.
Apply today for this exciting opportunity to be part of our growing team!
Remote work options may be considered on a case-by-case basis and if approved by the Company.
The Export Analyst will be primarily responsible for ensuring that all international affiliate orders are processed accurately, compliantly and efficiently in accordance with all J&J SOPs, specific country shipping requirements and all Government Laws and Regulations. In addition, the Export Analyst will be responsible for integrating and/or streamlining the Export processes to best leverage J&J resources.
Key Responsibilities:
* Understand and optimize Export processes to improve lead times and efficiencies. Implement automation and digital improvements where possible.
* Advise management of changing needs of customer base and recommend process changes to accommodate customer requirements.
* Responsible for providing processes, troubleshooting, and solutions to Sr. Coordinators on Export team as it relates to system capabilities, processes, and affiliate management.
* Ensure adherence to all policies, procedures, regulations, and quality compliance (FDA, DEA, J&J QA standards) to be ready for internal and external audits
* Export Analyst will lead projects to support system upgrades, new product launches, new country launches, recalls, acquisition, and divesture activities as appropriate.
* Lead and support implementation of projects, ensuring clear and timely communication on status to business partners.
* Partner with Supply Chain, E2E Global Production Planning, Transportation, Operations, Controlled Substance Compliance, RD&S, etc. to resolve issues, complaints and/or adhoc inquiries.
* Investigate and research to resolve issues, present the data and effectively communicate action plan and resolution to affiliates and leadership, as the need arises.
* Develop deep knowledge of Export processes, country policies, metrics, and regulatory standards.
* Drive digital analytics to create and customize Export lead time metrics dashboard.
* Write and maintain SOPs in Tru-Vault to ensure all Export processes are clearly documented, standardized, and trained.
* Export Analyst will act as lead trainer for new resources and others as appropriate
Qualifications
Education:
* Minimum of a Bachelor's/University or equivalent degree is required
Experience and Skills:
Required:
* A minimum 3 years of working experience
* The ability to handle ambiguity within the J&J NA Deliver and Supply Chain enterprise
* Advanced order management systems knowledge
* Prior project work experience
* Analytical and/or Lean Thinking background
* Ability to work with individuals from different cultures and backgrounds
* Demonstrates an understanding of the supported franchises and business processes needed to achieve results.
* Understands relevant products and applies this knowledge to day-to-day responsibilities
* Customer-centric background
* Ability to build professional relationships across functions and sites, both internally and externally, to achieve shared goals
* Experience analyzing problems, issues, and situations.
* Ability to communicate expertly and effectively through multiple channels (i.e., phone, email, and other business correspondence)
* Ability to effectively present information and respond to questions from peers and supervisors / managers
Preferred:
* Knowledge and experience in import/export
Other:
* Ability to work non-standard hours due to Global affiliate business needs
* Ability to travel up to 10% of the time; international and domestic
For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit *********************
Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s):
* United States - Requisition Number: R-045234
* Canada - Requisition Number: R-047403
Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.
Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via *******************/contact-us/careers, internal employees contact AskGS to be directed to your accommodation resource.
Required Skills:
Preferred Skills:
Analytical Reasoning, Business Behavior, Customer Centricity, Customer Intelligence, Customer Service Philosophy, Customer Support Operations, Customer Support Platforms, Customer Support Policies and Procedures, Customer Support Trends, Data Analysis, Execution Focus, Issue Escalation, Mentorship, Order Processing, Service Excellence, Service Request Management
Auto-ApplySocial Media Specialist - Shockwave Medical
Santa Clara, CA jobs
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at *******************
**Job Function:**
Digital Marketing
**Job Sub** **Function:**
Social Media
**Job Category:**
Professional
**All Job Posting Locations:**
Santa Clara, California, United States of America
**Job Description:**
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for humanity. Learn more at *******************/.
Fueled by innovation at the intersection of biology and technology, we're developing the next generation of smarter, less invasive, more personalized treatments. Ready to join a team that's pioneering the development and commercialization of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease. Our Shockwave Medical portfolio aims to establish a new standard of care for medical device treatment of atherosclerotic cardiovascular disease through its differentiated and proprietary local delivery of sonic pressure waves for the treatment of calcified plaque.
Johnson & Johnson is hiring for a **Social Media Specialist** **- Shockwave Medica** l to join our team. The position is **FULLY REMOTE** and can sit anywhere in the US **.**
**Position Overview:**
We are seeking a highly organized and creative Social Media Specialist to join the marketing team at Shockwave Medical, a part of Johnson & Johnson MedTech. This role requires a dynamic, strategic thinker to help manage and grow our social media presence across multiple platforms. As a collaborative individual, the Social Media Specialist will engage with cross-functional team members to support the creation, review and publication of high-value social content, analyzing performance and implementing optimizations. The ideal candidate is detail-oriented, results-driven and passionate about contributing to Shockwave's growth. This position reports to the Senior Brand Strategy Manager.
**Responsibilities:**
+ Assist with the social media post lifecycle from incoming request to publication to promotion for content on the Shockwave Medical social channels.
+ Work cross-functionally with product teams, medical affairs, legal, regulatory and compliance to ensure messaging alignment, brand consistency and clinical accuracy.
+ Collaborate in the planning, development and deployment of social media campaigns, ensuring timely and effective social support toward the campaign goals.
+ Manage social listening to track sentiment and gather insights relevant to the industry.
+ Monitor, respond to, and engage with the social community (followers, customers, and key opinion leaders) in a meaningful and compliant way.
+ Lead competitive listening on social media, synthesize insights and communicate findings to competitive landscape stakeholders to inform marketing strategy.
+ Track and analyze social performance metrics (reach, engagement, conversions, etc.) and report regularly to stakeholders. Use data to refine strategy and optimize content performance.
**Requirements:**
+ College degree (BA or equivalent), with relevant concentration such as Communications or Marketing or equivalent experience.
+ 2+ years of experience in marketing, preferably in the MedTech or broader healthcare industry; agency experience a plus.
+ Experienced understanding of social media platforms (including X/Twitter, LinkedIn, Facebook and Instagram), trends, and best practices.
+ Excellent organization, attention to detail, and accuracy in all work.
+ Strong writing, editing, and storytelling skills.
+ Ability to proactively manage multiple projects and meet deadlines in a fast-paced, regulated environment.
+ Proficient experience with social media management tools (e.g. Hootsuite, Sprout Social, etc.)
+ Ability to work cross-functionally with internal teams and external partners to ensure cohesive marketing efforts.
+ Collaborative interpersonal skills with the ability to build and maintain positive relationships.
+ Self-motivated with a strong desire to learn and grow.
_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:**
Collaborating, Communication, Organizing, Project Management, Strategic Thinking
**Preferred Skills:**
Analytical Reasoning, Brand Reputation Management, Business Behavior, Competitive Landscape Analysis, Content Creation, Content Management, Customer Analytics, Customer Retentions, Digital Marketing, Digital Metrics, Execution Focus, Innovation, Process Oriented, Project Support, Relationship Building, Researching, Social Media Benchmarking, Social Media Management
**The anticipated base pay range for this position is :**
US: $77.000 - $117,000 / Bay Area: $75,000 - $135,000
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. *********************************************
Pharmaceutical Sales - Associate Territory Manager - Cardiometabolic Health
Remote
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.
Territory Manager - Philadelphia, PA - CMH1_170153
The Territory Manager will be accountable for account-based selling to health care providers (HCPs) who prescribe and influence the treatment for the disease states represented in the Lilly portfolio. This includes customers in multiple HCP specialties, as well as representatives in key hospital accounts. They will be viewed as a credible expert and resource supporting all medicines and appropriate brand patients.
The Territory Manager will be accountable for driving results by embracing Lilly's suite of models: Lilly Selling Model, Lilly Competency Model and Account Management Model to meet the needs of customers through strong execution. Territory Managers will drive consistent ways of working within the Regional Healthcare Market. They will build relationships with key customers to drive utilization and adoption of our medicines for the right patients. Specific responsibilities include the following:
BUSINESS OWNERSHIP
• Promotes the full portfolio of priority products with multiple HCP specialties.
• Understands the marketplace within the territory; evaluates and tailors the territory strategy to grow and own business outcomes.
• Navigates the ever-changing healthcare environment and payer landscape to increase understanding of accounts and be able to impact key stakeholders to become trusted partners.
• Utilizes appropriate business insight tools, data, and analytics to identify trends, priorities, opportunities, and potential obstacles.
• Implements and adopts new technologies, including the integration of AI company-approved tools and other analytical capabilities to streamline customer interactions.
• Identifies and advocates for new opportunities to enhance the customer experience.
• Models a growth mindset to create positive experiences.
SELLING SKILLS / CUSTOMER EXPERIENCE
• Embraces and uses the company's selling, competency and account management models to elevate performance and drive results.
• Demonstrates high learning agility to understand disease state, marketplace, clinical trials, and product label.
• Promotes the BU portfolio by planning for and engaging in patient-centered dialogues with customers.
EXECUTION / RESULTS
• Promotes across BU-portfolio and across HCP specialties, driving consistent ways of working within the Regional Health Care Market to meet customers' needs. Appropriately, fully utilizes the Virtual Medical Hub.
• Achieves targeted sales and execution metrics while adhering to company policies and procedures.
• Owns the customer relationship for product promotion, on-label medical questions, and general market access.
• Holds self-accountability for results and performance across all accounts, from individual HCPs to large health systems.
• Builds and maintains relationships with both internal and external partners to foster trust and create collaborative success.
BASIC QUALIFICATIONS
• Bachelor's degree.
• Professional certification or license required to perform this position if required by a specific state.
• Valid US driver's license and acceptable driving record is required.
• Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization and/or visas for this role.
ADDITIONAL SKILLS / PREFERENCES
• Demonstrated business ownership skills, selling/customer experience skills, and execution/results.
• Account based selling experience. Ability to identify and engage staff members in accounts.
• Strong learning agility, self-motivation, team focused, and emotionally intelligent.
• Bilingual skills as aligned with territory and customer needs.
• Residence within 30 miles of the territory boundary.
From
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (******************************************************** for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.
Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups.
Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$63,000 - $151,800
Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
#WeAreLilly
Auto-ApplySenior Global Quality Auditor
Remote
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.
Position Brand Description:The Sr. Principal Associate - Quality Auditor is part of the Global Quality Auditing and Compliance (GQAAC) division and provides quality assurance through the execution of internal and external audits in support of pharmaceutical development, non-clinical and clinical research, product commercialization, pharmacovigilance and consumer information quality (CIQ) for Lilly. Through auditing, the Sr. Principal Associate - Quality Auditor assures that GXP operations conducted and sponsored by Lilly are performed in accordance with company standards, policies, procedures and practices and are compliant with current regulatory requirements and expectations and applicable guidelines and industry standards.GQAAC has adopted a proactive approach to ensure the effective implementation of a continuous quality assurance program. This program has the objectives of guaranteeing compliance with regulations in all geographies where Lilly operates and of further enhancing the quality of operations of Lilly and their contracted parties. The Sr. Principal Associate - Quality Auditor is an expert quality professional, acting as a key contributor to the development and execution of the GQAAC audit program within the GXP area(s) of responsibility.Key Objectives/Deliverables:The following activities will be performed according to current GQAAC procedures, guidelines and tools. These responsibilities are not intended to be all-inclusive:Auditing
Scheduling, preparing, conducting and reporting Global Quality audits and assessments of research and commercial operations, both internally and externally (contracted) to assess the level of compliance with company standards, policies, practices and procedures and current regulations and guidelines. This includes leadership of audit teams -including GXP- and ability to successfully execute a portfolio of complex audits as lead or solo auditor, as appropriate (e.g.: for cause, process and system audits, affiliates, large TPOs and pre-inspection audits). Performance of this work requires limited supervision.
Participate in mock-inspections, as appropriate.
Participate or lead the risk assessment of research and commercial operations. Integrate the information obtained through auditing and risk assessment and influence actions within and across GQAAC and the business areas involved/impacted.
Drive the escalation of any compliance issues or significant risks identified during audits or when conducting risk assessment.
Meet the requirements outlined in quality standards, quality manuals, policies, procedures, and tools.
This implies establishment and maintenance of a comprehensive knowledge of all applicable regulations, technical knowledge, and training to meet these responsibilities.Global Quality - Business Related Responsibilities:
Identify the need and drive the revision of GQAAC quality system documents when appropriate. Participate or lead the preparation and/or review of standards, policies, procedures and guidelines that are used to establish quality requirements, when needed.
Participate or lead the preparation of organizational metrics and trending of audit findings, when required.
Provide advice to research and manufacturing operations on the interpretation of corporate and regulatory GXP requirements, when required.
Establish and maintain relationships with relevant regulatory authorities, including supporting or facilitation of regulatory inspections, when required.
Provide technical expertise in identifying, formulating, assembling and delivering quality and compliance education to customers, as required.
Influence internal and external customers and partners when improvement needs are identified.
Continuous Improvement Related to Role
Participate in the continuous improvement agenda related to the role to ensure compliance within a continually changing company, regulatory and industry landscape.
Represent assigned process within broader change and transformation initiatives.
Partner with GPhV risk assessor to drive innovation, simplify and standardize audit processes, including implementation of risk-based paper-based audit programs, where appropriate.
Enable successful implementation of GQAAC Management/Lead team technical strategies and improvements.
Personal Development
Maintain good interpersonal and communication skills with auditees and business areas with particular emphasis on verbal and technical writing skills.
Complete required training identified in the Individual Learning Plan
Be continually aware of current industry trends and regulatory agency interpretation of GXP requirements.
Seek self-development in GxP areas (e.g. grand rounds, attend training courses, conferences or association meetings) and share such information and knowledge with other members of the group or company to increase internal intelligence.
Mentor others in the implementation of GXP requirements.
Participate or lead divisional improvement efforts, including Six Sigma projects and departmental teams.
Act as a proactive coach for others within the organization: focused on systematic execution under highest standards of quality. The Sr. Principal Associate - Quality Auditor is considered a person of reference within the function / team for technical and general auditing advice.
Minimum Requirements:
Bachelors Degree - Preferred degree in physical or biological sciences, or other technical area.
Minimum of five (5) years' experience related to Pharmacovigilance (PV) or pharmaceutical industry.
Additional Preferences:
Experienced in working with Third Party Organizations.
Ability to analyze detailed technical scientific information, while understanding the bigger picture. The senior auditor should be able to clearly identify and assess risk and impact associated with specific and overall findings and situation for an auditable unit, event or case, and to articulate such risk and impact when communicating to the business (including senior management) and the quality organizations.
Ability to interpret and apply regulations, regulatory guidance, codes and public expectations, and identify and recommend compliance changes as appropriate.
Excellent interpersonal skills, ability to remain constructive and civil in difficult situations.
Ability to deliver timely and professional communications (oral and written) with precision and clarity to all levels of the organization.
Experienced in working on a global team and sharing knowledge.
Experience with computers, entering and managing data in databases.
Good analytical/problem-solving skills.
Ability to handle several complex projects in parallel.
Systematic approach to ensure self-safety and that of the audit team.
Work under pressure on multiple tasks concurrently and meet deadlines in a fast-paced work environment with frequent interruptions and changing priorities.
Proven ability to think and analyze from a process perspective. Project management skills.
Process information to identify linkages and trends and apply findings to compliance strategies as well as to individual assignments.
Work independently as well as collaboratively within a global team environment.
Deliver constructive feedback to customers while providing a high level of customer service.
Ability to influence and manage change/conflict.
Ability to think on your feet and be pragmatic in decision making.
Other Information: Domestic and international travel is required to fulfill these job responsibilities. Must be able to travel up to 40% (duration 1-2 weeks), sometimes on short notice.
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (******************************************************** for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.
Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups.
Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$65,250 - $187,000
Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
#WeAreLilly
Auto-ApplyDirector, US Oncology Marketing, INT Treatment Site Strategy & Execution Lead
Columbus, OH jobs
The U.S. Oncology business within our company is a growing and dynamic part of our company. We have an exciting opportunity to join our dynamic marketing team focusing on intismeran autogene, a cutting-edge individualized neoantigen therapy (INT), which represents a transformative approach to cancer treatment, as part of our alliance partnership.
We are seeking a **Director, US Oncology Marketing, INT Treatment Site Strategy & Execution Lead** . This role will be pivotal in the development and execution of innovative strategic commercial plans to support the seamless **end-to-end patient journey** for intismeran autogene. This process begins with the acquisition of patient tumor and blood samples, genetic sequencing of the samples, customized manufacturing of the individualized therapy and subsequent delivery back to the health care provider for administration to the patient in combination with our immuno-oncology product. This role will also drive the strategy to develop the treatment site network and site readiness for the launch of intismeran autogene.
This position will report to the **Executive Director, U.S. Oncology Marketing, Intismeran Autogene/Alliance** **Lead** and work cross-functionally with multiple teams across the organization to support the launch of this innovative therapy.
**Key Responsibilities** :
+ Develop and implement orchestration systems and processes to support the seamless end-to-end patient journey at treatment sites and ensure alignment with several cross functional teams that are involved in intismeran autogene treatment process, including but not limited to global orchestration lead, manufacturing, supply chain, IT, legal/compliance, market access, marketing, precision medicine, and field commercial.
+ Lead and develop the treatment network strategy to identify intismeran autogene treatment sites, site readiness strategy to integrate INT operations into treatment sites, and address potential operational bottlenecks at sites, ensuring a smooth commercial ordering experience.
+ Provide guidance and input for the development of the customer-facing INT orchestration software based on US market strategic needs and customer insights.
+ Collaborate closely with the Precision Medicine team to facilitate a smooth patient tumor and blood sample collection process, securing a seamless path to therapy manufacturing.
+ Enable the development and execution of the customer-facing field role strategy, focused on designing an effective field customer engagement model that aligns with unique business needs for intismeran autogene, including treatment site readiness and INT operational needs.
+ Identify strengths and risks to customer experience in the end-to-end patient journey. Develop and implement risk-mitigation strategies and enhancement features to support optimal customer experience with INT.
+ Research and implement industry best practices, identifying potential risks and gaps specific for INT, based on insights from similar individualized complex therapies (e.g. cell therapy, gene therapy, radioligand therapy).
**Required:**
+ Bachelor's Degree
+ Minimum of 8 years pharmaceutical business experience, including marketing, sales, and/or operations
+ Excellent project planning & management skills; strong analytical and problem-solving skills
+ Demonstrated track record of operational excellence, with comprehensive knowledge of commercial and/or clinical operations
+ In-depth understanding of healthcare hospital systems and community oncology practice operations.
+ Strong business acumen and ability to drive forward key initiatives in a fast-paced environment. Proven ability to drive execution across multiple cross-functional teams
+ Exceptional collaboration skills, both within commercial teams and cross divisional teams
+ Proven leadership skills with ability to influence without direct authority, navigating complex organizational structures
**Preferred:**
+ Advanced degree in a relevant field
+ Demonstrated track record of operational excellence, with comprehensive knowledge of commercial and/or clinical operations
+ Broad cross-functional experience within the pharmaceutical industry, including exposure to teams in manufacturing, supply chain, IT, finance, and business planning
+ Expertise in process improvement, with a strong background in methodologies such as Lean Six Sigma
+ Demonstrated ability to embrace a flexible, growth-oriented mindset
+ People management experience with a track record of managing and developing high-performing teams
+ Proven ability to manage strategic alliance partnerships
**Location** : Upper Gwynedd, PA, Rahway, NJ OR Remotely located
**Required Skills:**
Business Management, Communication, Customer Engagement, Data Analysis, Decision Making, Digital Marketing Campaigns, Gene Therapy, Healthcare Personnel (HCP) Marketing, Innovation, Leadership, Oncology Marketing, Risk Mitigation Strategies, Strategic Product Planning, Strategic Thinking, Team Management
**Preferred Skills:**
Current Employees apply HERE (*****************************************************
Current Contingent Workers apply HERE (*****************************************************
**US and Puerto Rico Residents Only:**
Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here (*************************************** if you need an accommodation during the application or hiring process.
As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:
EEOC Know Your Rights (******************************************************************************************
EEOC GINA Supplement
We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively.
Learn more about your rights, including under California, Colorado and other US State Acts (**********************************************
**U.S. Hybrid Work Model**
Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as "remote".
The salary range for this role is
$187,000.00 - $294,400.00
This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.
The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.
We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at ****************************************************** .
You can apply for this role through **************************** (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.
**San Francisco Residents Only:** We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance
**Los Angeles Residents Only:** We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance
**Search Firm Representatives Please Read Carefully**
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
**Employee Status:**
Regular
**Relocation:**
No relocation
**VISA Sponsorship:**
No
**Travel Requirements:**
25%
**Flexible Work Arrangements:**
Remote
**Shift:**
1st - Day
**Valid Driving License:**
No
**Hazardous Material(s):**
NA
**Job Posting End Date:**
01/17/2026
***A job posting is effective until 11:59:59PM on the day** **BEFORE** **the listed job posting end date. Please ensure you apply to a job posting no later than the day** **BEFORE** **the job posting end date.**
**Requisition ID:** R376296
Principal Medical Science Liaison
Irvine, CA jobs
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at *******************
**Job Function:**
Medical Affairs Group
**Job Sub** **Function:**
Medical Science Liaison
**Job Category:**
Scientific/Technology
**All Job Posting Locations:**
Ashland, Kentucky, United States, Ashland, Kentucky, United States, Atlanta, Georgia, United States, Baltimore, Maryland, United States, Birmingham, Alabama, United States, Boise, Idaho, United States, Charleston, South Carolina, United States, Charleston, West Virginia, United States, Charlotte, North Carolina, United States, Chicago, Illinois, United States, Cincinnati, Ohio, United States of America, Columbus, Ohio, United States, Dallas, Texas, United States, Denver, Colorado, United States, Des Moines, Iowa, United States, Detroit, Michigan, United States, Garden City, New York, United States, Hartford, Connecticut, United States, Indianapolis, Indiana, United States, Irvine, California, United States of America, Jackson, Mississippi, United States, Jacksonville, Florida, United States of America, Kansas City, Kansas, United States, Las Vegas, Nevada, United States, Lexington, Kentucky, United States {+ 15 more}
**Job Description:**
We are searching for the best talent to join our MedTech team as a **Principal Scientist, Medical Science Liaison, Neurovascular** . This role is Fully Remote in the United States.
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 *******************/
**Purpose:**
We are looking for a highly motivated Principal Scientist, Medical Science Liaison (MSL) in Johnson & Johnson MedTech - Neurovascular. In this role, you will be driving important initiatives in KOL engagement, advisory boards, research, publications, medical education, and field intelligence between our Neurovascular Scientific Affairs team and the academic/non-academic neurovascular community. This is a vital role that requires a blend of strategic understanding and expertise in Medical Affairs/Clinical Affairs to foster advancements in neurovascular technology and support the medical community. Primary responsibilities include developing and cultivating strong relationships with key opinion leaders (KOLs) and healthcare professionals, identifying unmet needs/scientific gaps in medical research and clinical practice paradigms, and cross functional collaboration with internal partners to deliver field and medical insights. You will participate in and/or drive special projects including: voice of customer events, physician initiated clinical studies and off-label conversations, internal and external education, and publication planning and execution. Your primary objective will be to bridge the gap between J&J MedTech Neurovascular and our neurovascular customers by maintaining detailed knowledge of our product platforms, understanding business and strategy objectives and goals, and staying updated on current literature and data in the neurovascular space.
**Major Duties & Responsibilities**
+ Support the development and implementation of strategic engagement plans to establish and maintain relationships with KOLs, interventionalists, operating room staff, and relevant medical societies in the neuro-interventional field.
+ Act as a scientific authority in neuro-intervention, providing medical, scientific, and practical / hands-on education to internal and external collaborators.
+ Collaborate with cross-functional teams, including Product Development, Clinical Affairs, Marketing, Scientific Affairs, and Research & Development, to provide scientific input and insights.
+ Communicate & streamline complex scientific information effectively to healthcare professionals, ensuring a clear understanding of the benefits and clinical utility of our neuro-interventional technology e.g., provide clinical support during voice of customers sessions.
+ Stay up to date with the latest scientific research, medical publications, and emerging trends in neuro-intervention to provide up-to-date insights and guidance to internal and external partners.
+ Own the preparation of materials needed to deliver presentations on the science supporting the portfolio and participate in scientific symposia, conferences, and educational programs to improve awareness and understanding of the platforms.
+ Support clinical studies and research initiatives by providing scientific and technical expertise and maintaining open lines of communication to the external KOLs and authors.
+ Provide training and education to internal teams, including Sales and Marketing, to ensure a deep understanding of scientific message.
+ Participate in internal trainings from Professional Education, and Scientific Affairs University teams to ensure a deep and detailed understanding of our neuro-interventional technology.
+ Organize, analyze, and review/report on customer, scientific, and market information on pre-launch and marketed products.
+ Develop educational materials and support programs for personnel.
+ Discuss Investigator Initiated and Collaborative study concepts with clinicians.
**Requirements**
+ Advanced degree or equivalent required (MD, PhD)
+ Minimum 3 years of experience working in the biotech industry, focusing on neuro-intervention preferred.
+ Minimum of 2 or more years of experience in a Medical Affairs/Medical Science liaison/Clinical Practice preferred.
+ Extensive knowledge of neuro-interventional technology and techniques preferred.
+ Strong understanding of clinical research methodologies, regulatory guidelines, and medical terminology.
+ Proven track record to establish and maintain relationships with KOLs, interventionalists, and other healthcare professionals.
+ Ability to analyze and interpret scientific data quickly and accurately.
+ Excellent interpersonal, communication and presentation skills, with the ability to effectively communicate complex scientific concepts to both scientific and non-scientific audience.
+ Highly self-motivated, independent, and adaptable to changing priorities and environments.
+ Given focus of role for US market, candidate must have work authorization in USA
+ Excellent computer skills, especially with the use of Microsoft Office
+ Travel Requirement: 75%
\#LI-AM2
_Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act._
_Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center (********************************) or contact AskGS to be directed to your accommodation resource._
**The anticipated base pay range for this position is :**
$115,000-$197,000 ; California Bay Area: $139,000-$220,000
Additional Description for Pay Transparency:
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; 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 of 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.
Design + Human Factors Engineering Senior Director
Remote
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.
Position Title: Design + Human Factors Engineering Senior Director -DDCS
Department Name: Delivery, Device and Connected Solutions
Purpose:
In 1992, Eli Lilly and Company established the Delivery Device business to create, develop, launch and continuously improve proprietary delivery device systems. This business is unique to the broader Lilly Research Labs organization due to its focus on patient-centered delivery system solutions, its innovative approach to delivery platforms utilizing both internal and external technologies, and its level of integration with the commercial groups and Business Units. The Delivery, Device and Connected Solutions (DDCS) organization leverages many alliances in design and manufacturing to rapidly convert proprietary product concepts into products that meet the users' needs and intended uses. This business enables over $30 billion in pharmaceutical sales and is projected to drive company growth in the coming years.
In response to this growing portfolio and increasing global regulatory expectations, the DDCS organization requires a Design and Human Factors Engineering Senior Director to provide leadership to support product innovation and product development for delivery and device systems at Eli Lilly and Company. This position is responsible for providing strategic direction, execution and reporting of design and human factors activities across all medical device, combination product and packaging programs, according to current regulations and appropriate guidelines within the medical device and biopharmaceutical industries.
Position responsibilities:
Design and Human Factors:
Lead and grow a top-tier engineering and science organization, which includes expertise in design and human factors engineering that is applied across the portfolio.
Ensures that:
Human capabilities and limitations are adequately reflected in the system requirements
Human performance characteristics and their associated cost, benefits, and risks assist in deciding among alternatives (especially since lifecycle operation and support costs are often largely dependent upon personnel-related costs)
Human performance and safety risks are appropriately addressed in planning.
The staff is highly trained in Human Factors processes, relevant standards (IEC 62366, ANSI/AAMI HE75) and FDA guidance.
Human Factors Standards are appropriately documented in the Design Control Quality System.
Project milestones are met by identifying and managing risks and escalating as appropriate.
Functional budgets and project forecasts are maintained in compliance with P&L
People:
Responsible for developing and managing the Design + Human Factors Engineering team.
Provides leadership, feedback, coaching, performance and career development support to direct reports.
Ensures career development discussions, talent assessment, and succession planning are in place for employees.
Builds and executes a comprehensive long-range recruiting strategy and technical succession plan to maintain a highly competitive cross-functional technical organization.
Strategy / Corporate Integration:
Given the anticipated growth in the delivery business both in terms of the existing base of business and future ventures, the Design & Human Factors Engineering Senior Director will be accountable for the execution of a Delivery and Device Strategy with other members of the management team.
The delivery strategy and project workload are closely linked to that of the Business Units, Sales Affiliates, Medical, Manufacturing and Marketing. The position would work closely with the above groups to consistently align the strategies and projects.
Partner with Regulatory to serve as an opinion leader in the drug delivery device and pharma industry on human factors and help draft policy positions across Lilly and the industry
Relationship Management:
Ensure compliance with external collaborations
Create and maintain effective relationships and alignment with Lilly partners external to DDCS (e.g. Quality, Manufacturing, Regulatory, Digital Health, Business Units)
Build strong relationships with external vendors and lead external collaboration efforts to support development strategies as they may evolve
Minimum requirements:
MS in Engineering with 10+ years or PhD in Engineering with 5+ years of delivery device design and development experience.
Experience with regulatory agencies interactions and/or regulatory submissions of delivery devices and combination products.
Experience working within a Sponsor organization
Working knowledge of HF regulatory requirements, protocols, IRBs, Usability studies and reporting.
Human subjects research bioethics and study design
Prior supervisory experience of team organization
Ability to work effectively across boundaries
Demonstrated quality mindset, ability to influence and leadership capabilities
Additional Skills and Preferences:
Understanding of and experience with device/drug regulations, standards and guidances as they pertain to specific functional responsibilities (e.g. CFR 820.30, ISO 13485, ISO 14971, IEC 62366, ANSI/AAMI HE75)
Business skills (capital and expense differentiation and impact on COGS and variance).
Communication and interpersonal skills necessary for broad interactions at all levels of the corporation.
Broad integrated technical knowledge of system and design engineering, product development, and commercialization (device, container closure, packaging, etc.).
Experience working in a diverse networked technical organization with proven skills in managing suppliers and alliance partners.
Leadership skills with previous experience managing technical personnel and alliance partnerships
Demonstrated ability to lead cross-functional teams
Additional Information
Position Location: Indianapolis, IN
Ability to travel ~10-20% of the time, both domestic and international
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (******************************************************** for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.
Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups.
Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$163,500 - $264,000
Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
#WeAreLilly
Auto-ApplyField Clinical Specialist - Shockwave - Remote - Colorado
Denver, CO jobs
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at *******************
Job Function:
MedTech Sales
Job Sub Function:
Clinical Sales - Hospital/Hospital Systems (Commission)
Job Category:
Professional
All Job Posting Locations:
Denver, Colorado, United States, Santa Clara, California, United States of America
Job Description:
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for humanity. Learn more at *******************/.
Fueled by innovation at the intersection of biology and technology, we're developing the next generation of smarter, less invasive, more personalized treatments. Ready to join a team that's pioneering the development and commercialization of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease. Our Shockwave Medical portfolio aims to establish a new standard of care for medical device treatment of atherosclerotic cardiovascular disease through its differentiated and proprietary local delivery of sonic pressure waves for the treatment of calcified plaque.
Position Overview
The Field Clinical Specialist is a visible position that will provide case support to physicians within certain territories. Case support will be done on peripheral and coronary interventional procedures in the pre-market and post-market phases of product development with the Shockwave Medical Intravascular Lithotripsy (IVL) technology. The Field Clinical Specialist will also play a critical role in clinical studies including device training, case support and ensuring timely data collection for clinical programs. Case support may be required to support other territories at certain times.
Essential Job Functions
* Physician and hospital staff training, and procedural case coverage to ensure the safe and effective use of medical devices.
* Effectively meet the needs of internal and external customers with a sense of urgency and drive.
* Present clinical study training materials based on investigational plans to support the safe and effective use of medical devices, inclining study protocol, instructions for use, core lab manuals and case report forms.
* Manage key study investigators; foster and maintain strong relationships through direct interactions with medical advisors and clinical leaders.
* Partner with other clinical research colleagues to meet business needs in the field including site re-training, data collection for timely database locks and resolution of critical issues.
* Administrative activities including training to procedures, manage territory travel and budgets.
* Other duties as assigned.
Requirements
* Minimum Bachelor's Degree in business, science, nursing or related fields, or equivalent experience.
* Minimum 2 years' experience directly supporting interventional or surgical procedures within a hospital setting OR, 1 year of industry, hospital-based life sciences, sales support experience. Cardiovascular industry experience preferred but not required.
* Working knowledge of clinical research, Good Clinical Practice (GCP) and regulatory compliance guidelines for clinical trials.
* A history of effective collaboration with regulatory agencies through clinical studies and market releases.
* Product knowledge including product vigilance and medical device reporting.
* High attention to detail and accuracy.
* Computer skills (MS Office products, word processing, spreadsheets, etc.).
* Finance and budgeting knowledge.
* Good prioritization and organizational skills.
* Excellent critical thinking skills.
* Excellent influencing and negotiation skills.
* High energy and results-oriented individual who is mature and successful in a business environment and is skilled in motivating and inspiring people.
* Entrepreneurial "hands-on" experience. Pro-active and "can do" attitude.
* Ability to consider and accept feedback and suggestions for continuous improvement.
* Works effectively on cross-functional teams. Demonstrated willingness to make decisions and to take responsibility for such.
* Effective written, verbal and presentation skills with all levels of customers and management.
* Ability to work in a fast-paced environment while managing multiple priorities
* Operate as a team and/or independently while demonstrating flexibility to changing requirements.
* There may be continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
* Significant travel >50% of time requiring the employee to be effective in a remote manner.
* Employee may be required to lift objects up to 40lbs or more. Employees will be required to work in an air conditioned office space and possibly perform some tasks in our non-temperature controlled warehouse space.
Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, please contact us via *******************/contact-us/careers or contact AskGS to be directed to your accommodation resource.
Required Skills:
Preferred Skills:
Business Behavior, Communication, Consulting, Cross-Selling, Customer Centricity, Customer Effort Score, Customer Retentions, Execution Focus, Goal Attainment, Hospital Operations, Innovation, Market Research, Medicines and Device Development and Regulation, Sales, Solutions Selling, Sustainable Procurement, Vendor Selection
The anticipated base pay range for this position is :
100,000.
Additional Description for Pay Transparency:
Potential Variable Comp 35K
Auto-ApplyRegulatory Affairs Senior Director - Global Regulatory Leader - Obesity
Remote
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
Auto-ApplyUndergrad Intern - Amgen Foundation (Summer 2026)
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.
Undergrad Intern - Amgen Foundation (Summer 2026)
What You Will Do
Let's do this. Let's change the world. During this program, you will gain real-world experience in the corporate social responsibility field and learn new skills around the management and operations of the Amgen Foundation. The Amgen Foundation is the main philanthropic arm of the biotechnology company Amgen, Inc.
To help strengthen our staff engagement programs, analyze data to identify trends and potential areas for improvement in the Foundation's community giving programs. On completion, independently study and synthesize results, then share insights.
Conduct independent research to learn about emerging staff engagement trends outside of our organization and share those back with the team. Recommend new ideas and approaches to engage employees in community giving.
Shadow and support our team to learn about the Amgen Foundation's signature global programs; participate in short-term projects.
Support the Foundation's management of its global communications strategy and operations.
Support annual community grants cycle; participate in short-term projects, including analyzing and sharing insights around submitted grant applications.
Provide support for the Foundation's day-to-day business operations that helps make the team's work smoother and more effective.
What We Expect of You
We are all different, yet we all use our unique contributions to serve patients. The curious individual we seek is a collaborative team member 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
Degree concentration in Business Administration, Economics, Communications, Public Administration, Nonprofit Management, or Science Education
Able to analyze and interpret data using a variety of reporting tools. Proficiency in conducting research and compiling comprehensive reports.
Strong written and verbal communication skills. Able to effectively convey ideas through reporting and confidently present ideas and results to stakeholders of all levels.
Able to produce reliably high-quality work with a keen attention to detail and adherence to consistently high standards.
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 [input market pay range].
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-229821
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 full-time roles is not guaranteed.
As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
.
Salary Range
-
Auto-ApplyAssociate Compensation & Benefits Tax Counsel
New Brunswick, NJ jobs
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at *******************
Job Function:
Finance
Job Sub Function:
Tax
Job Category:
Professional
All Job Posting Locations:
New Brunswick, New Jersey, United States of America
Job Description:
Johnson & Johnson is seeking an experienced Associate Compensation & Benefits Tax Counsel. This role is located in New Brunswick, New Jersey.
This position reports to the VP Compensation & Benefits Tax Counsel. The candidate will provide high level technical tax and legal advice to management in the administration of the company's worldwide employee compensation and benefit plans.
Incumbent is responsible for ensuring compliance with laws and regulations applicable to employee compensation and benefits. Specifically, incumbent will advise management regarding tax and legal requirements in areas including qualified retirement plans, stock based compensation, employee welfare benefit plans, employee fringe benefits, mergers, acquisitions & divestitures, plan asset investments, and executive compensation matters. The Associate Compensation & Benefits Tax Counsel will also advise on payroll withholding and reporting matters and other global employee compensation and benefits matters.
Remote work options may be considered on a case-by-case basis and if approved by the Company.
Position Requirements:
* A Juris doctor degree from an accredited law school is required.
* A minimum of one active state (or District of Columbia) bar admission is required.
* A minimum of 10 years of experience at a law firm, accounting firm and/or major corporation advising clients or management on a wide variety of employee compensation & benefits tax and legal matters is required.
* Working knowledge of the provisions of the Internal Revenue Code applicable to the taxation of employee compensation and benefits and of the Employee Retirement and Security Act of 1974 (ERISA) is required.
* Experience advising on compensation and benefits matters in mergers, acquisition, and divestiture transactions is required.
* Experience advising on plan asset investment matters is required.
* Incumbent will also require excellent business partnering and communication skills - specifically the ability to communicate highly technical matters to management whose knowledge may be more general.
Preferred Requirements/Competencies:
* Exposure to and general knowledge of the laws of some major non-U.S. jurisdictions with respect to employee compensation and benefit matters, reporting and withholding, and employee location compliance are preferred.
The expected base pay range for this position is $173,000 to $300,000.
- The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation's performance over a calendar/performance year. Bonuses are awarded at the Company's discretion on an individual basis.
Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short and long-term disability, business accident insurance, and group legal insurance.
Subject to the terms of their respective plans, employees are eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)).
This position is eligible to participate in the Company's long-term incentive program. 6
Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:
- Vacation - 120 hours per calendar year
- Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado -48 hours per calendar year; for employees who reside in the State of Washington -56 hours per calendar year
-Holiday pay, including Floating Holidays -13 days per calendar year
- Work, Personal and Family Time - up to 40 hours per calendar year
-Parental Leave - 480 hours within one year of the birth/adoption/foster care of a child
- Bereavement Leave - 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
- Caregiver Leave - 80 hours in a 52-week rolling period 10 days
- Volunteer Leave - 32 hours per calendar year
- Military Spouse Time-Off - 80 hours per calendar year
Additional information can be found through the link below.
For additional general information on Company benefits, please go to: - *********************************************
Required Skills:
Preferred Skills:
Agility Jumps, Audit Management, Consulting, Critical Thinking, Fiduciary Liability, Financial Analysis, Financial Reports, Financial Risk Management (FRM), Financial Trends, Leadership, Organizing, Process Optimization, Program Management, Tax Advising, Tax Compliance, Tax Management, Transparency Reporting
The anticipated base pay range for this position is :
173000-300000
Additional Description for Pay Transparency:
Auto-ApplySecOps Engineer - Identity Operations Tech Lead
Remote
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.
Are you eager to make a significant impact in the cybersecurity field? We are seeking a Technical Lead role to infuse our team with innovative ideas and daring solutions. In this position, you will play a crucial role in delivering how our organization ensures secure, appropriate, and timely access to enterprise resources, while also supporting the capabilities that help us achieve and sustain our Identity and Access Management strategy.
What You'll Be Doing
The SecOps Engineer- Identity Operations Tech Lead role of Identity and Access Management (IAM) is a technical leadership role responsible for the delivery and support for the company's 24/7 identity platforms and services.
This role plays a critical part in ensuring the secure and efficient support of identity and access services within our organization. The responsibilities will encompass day-to-day operations, incident management, change management, and problem resolution related to IAM focusing on Authentication services. This role will also collaborate with cross-functional teams to maintain compliance, address risks, and enhance our IAM program. This includes working closely with the Operation Manager, the Service Leads and other Technical leads to ensure alignment of priorities, allocating resources effectively, and driving operational excellence.
What You'll Bring:
Team and Technical Leadership:
Recruit, hire and develop a high-performing identity operation engineers.
Provide coaching, career development, performance management and professional growth opportunities.
Foster a culture focused on innovation, continuous learning, and operational discipline.
Cultivate a diverse and inclusive team fostering different perspectives and backgrounds.
Keep abreast of the latest developments in IAM technologies, security threats, and regulatory changes.
Drive the adoption of innovative and creative solutions to address complex, global IAM problems.
Serve as technical lead and an escalation point for team members.
Operational Excellence:
Provide technical leadership in the execution and processes for escalations, incident management, change management, problem resolution and continuous improvement that enable the support of 24/7 services.
Continuously monitor IAM systems performance and health to ensure optimal operation. Perform regular maintenance tasks to prevent issues.
Respond promptly to system alerts and incidents, troubleshoot issues, and implement solutions to restore services as quickly as possible.
Manage and maintain all components of IAM systems. Ensure that all systems are up-to-date with the latest patches and security updates.
Analyze system performance metrics and make recommendations for improvements. Implement changes to enhance system efficiency and reduce downtime.
Maintain detailed documentation of system configurations, procedures, and incident reports. Provide regular status updates and reports to management.
Work closely with other IT teams, developers, and stakeholders to ensure seamless operation of services. Communicate effectively to resolve issues and implement changes.
Assess current system capacity and plan for future growth. Ensure that resources are allocated efficiently to meet demand.
Provide technical support to users as it pertains to issues and requests on Identity services.
Support response to audit and compliance requests pertaining to Identity services.
Develop and implement solutions to resolve identified problems. Ensure that solutions are tested and validated before deployment.
Perform detailed root cause analysis and document findings. Develop and implement corrective actions to prevent recurrence.
Proactively identify opportunities for process improvements and implement best practices to enhance problem management processes.
Your Basic Qualifications:
Bachelor's degree in Computer Science, Engineering or related technical field.
5+ years of proven experience in supporting, delivering and securing Identity and Access Management services.
5+ years technical experience with Entra ID and/or Active Directory.
5+ years of experience with authentication and authorization technologies and federated identity standards and protocols (multifactor authentication, certificate-based authentication, LDAP Kerberos, OAuth, SAML, OpenID Connect).
Additional Preferences:
Experience in privileged access management including CyberArk.
Experience with encryption, secrets management. internal certificate authority, public certificate provisioning, enabling certificate management, and/or digital signatures.
Experience with Microsoft Identity Manager.
Experience with IT service management (ITIL).
Effective collaboration with other technical counterparts, Leaders and Stakeholders, to deliver and support IAM solutions.
Ability to work with a distributed and virtual team.
Critical thinking, analytical skills, and thought leadership.
Excellent communication and presentation skills, and ability to adapt messaging for diverse audiences.
An understanding of common services used in cloud-based architecture, with experience in AWS and/or Azure, and awareness of cloud platform security and controls.
Relevant certifications such as CISSP, CISM, or similar.
Additional Information:
Remote or Hybrid Onsite if in Indianapolis, IN
Expected Shift Hours: 9:00 am - 6:00 pm US Eastern Standard Time (EST)
Participate in weekend on-call once per month
Travel 10-15 %
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (******************************************************** for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.
Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups.
Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$63,750 - $198,000
Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
#WeAreLilly
Auto-ApplyGlobal Safety Medical Director - Hematology/Oncology
Remote
Career CategorySafetyJob DescriptionJoin Amgen's Mission of Serving Patients
At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do.
Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.
Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.
Global Safety Medical Director - Hematology/Oncology
What you will do
Let's do this. Let's change the world. In this vital role you will be accountable for the staff management and resource allocations in Global Patient Safety and support GPS in the establishment of a highly effective global safety organization in full compliance to worldwide regulations. The GSO is accountable for the overall safety profile and all product-related decisions and results for assigned products supporting Hematology-Oncology portfolio. The GSO leads the Safety Analysis Team (SAT), Global Safety Team (GST) and is a core member of the Executive Safety Committee (ESC). The GSO also is a member of the Evidence Generation Team and other relevant cross functional teams. The GSO will be assigned as delegate for the TAH as needed.
Validate safety signals and lead safety signal assessments
Develop and maintain Core Safety Information (core data sheet, core risks in informed consent forms, etc.)
Prepare/review core and regional risk management plans including additional risk minimization measures
Prepare/review safety sections of periodic aggregate reports
Provide safety input to protocols, statistical analysis plans, and clinical study reports
Prepare/review safety sections of new drug applications and other regulatory filings
Serve as safety expert on Evidence Generation Team for assigned products
Inspection Readiness
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is a leader with these qualifications.
Basic Qualifications:
MD or DO degree from an accredited medical school
AND
Completion of an accredited medical or surgical residency
OR
Clinical experience in either an accredited academic setting or private practice (including hospital based) setting
Preferred Qualifications:
Product safety in the bio/pharmaceutical industry or regulatory agency
Previous management and/or mentoring experience
Experience in the study/research and/or treatment of Oncology disease states
What you can expect of us
As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way.
The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.
In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:
A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
Stock-based long-term incentives
Award-winning time-off plans
Flexible work models, including remote and hybrid work arrangements, where possible
Apply now and make a lasting impact with the Amgen team.careers.amgen.com
In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.
Application deadline
Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.
As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
.
Salary Range
243,245.00 USD - 319,267.00 USD
Auto-ApplySpecialist SAP Business Systems Analyst, Enterprise Asset Management
Remote
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.
Specialist SAP Business Systems Analyst, Enterprise Asset Management
What you will do
Let's do this. Let's change the world. In this vital role you will be responsible for architecting, designing, and implementation of SAP S/4HANA Enterprise Asset Management (EAM) solutions (Planning Plant, Maintenance Plant, Asset Master Data, Maintenance Plans, Work Packs, Maintenance Orders, Task Lists, Planning and Scheduling, Asset Performance Management) across all the Amgen manufacturing and distribution sites. This is a mid-level techno-functional role that supports Agile project execution and cross-functional coordination across a complex regulated environment. The Specialist SAP Business Systems Analyst serves as a bridge between Engineering stakeholders, Operations and Operations IT, SAP consultants, and technical teams. As a seed team member, this individual will help plan and onboard a broader delivery team while managing the scope, timeline, and expectations across a compliance-sensitive transformation architecting the SAP EAM solution as part of a large-scale transformation from Maximo to SAP S/4HANA in a regulated life sciences environment. The Specialist SAP Business Systems Analyst is a core member of the seed team that will evolve into a long-term SAP EAM product team. This role will ensure technical alignment, compliance, and scalable design while overseeing the onboarding of internal and partner resources, particularly in the offshore capability center. This position requires deep expertise SAP Plant Maintenance (PM), Materials Management (MM), Quality Management (QM), Finance (FI) and Controlling (CO) modules with a solid understanding of Production Planning (PP), Human Capital Management (HCM), Supply Chain Management (SCM) functionalities.
Roles & Responsibilities:
Drive requirements gathering, user story development, and stakeholder alignment across engineering value streams.
Support SAP EAM Architect in configuration, and optimization of SAP EAM solution
Manage and refine Agile delivery plans, sprint timelines, RAID logs, and change impact tracking in close coordination with product owners and scrum masters.
Support transition from Maximo to SAP EAM by coordinating process mapping, data readiness, and training strategy.
Ensure alignment with GxP regulatory expectations and 21 CFR Part 11 compliance throughout the SDLC, especially in validation and UAT phases.
Track and validate data migration efforts, ensuring legacy system data meets quality and integrity standards under enterprise data governance policies.
Clearly manage stakeholder expectations across engineering, IT, and compliance domains.
Serve as liaison between Engineering business leads and SAP technical team to define and validate to-be processes.
Oversee onboarding and integration of offshore and contract resources into the SAP EAM implementation team framework.
Ability to travel to work shops, go lives, etc. ~20%!
Lead/Oversee and mentor junior team members to ensure the effective execution of the projects and services.
Participate in sprint planning, reviews, and retrospectives to deliver and sustain Amgen's S/4HANA ecosystem utilizing the Scaled Agile Framework (SAFe).
Facilitate UAT sessions, document process flows, and trace requirements to configuration.
Support the development of innovative solutions that drive speed to value via AI/ML and leading control practices.
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The professional we seek will have these qualifications.
Basic Qualifications:
Doctorate degree
OR
Master's degree and 2 years of SAP implementation experience in SAP PM, MM, QM, and FI/CO modules experience
Or
Bachelor's degree and 4 years of SAP implementation experience in SAP PM, MM, QM, and FI/CO modules experience
Or
Associate's degree and 8 years of SAP implementation experience in SAP PM, MM, QM, and FI/CO modules experience
Or
High school diploma / GED and 10 years of SAP implementation experience in SAP PM, MM, QM, and FI/CO modules experience
Preferred Qualifications:
Must-Have Skills:
Strong hands-on experience configuring and customizing SAP S/4 PM, QM, and MM modules and Maintenance Order, MRP, and Calibration process
Strong understanding of Inter and Intra company inventory transfers, contract maintenance processes and Integrating SAP with external business systems, data historians, and potentially manufacturing execution systems for APM use cases.
Ability to design and implement solutions based on business requirements, including debugging and root cause analysis.
Experience in creating detailed documentation, including functional specifications, test cases, and compliance reports.
Good-to-Have Skills:
Knowledge of Internet of Things (IoT), Artificial Intelligence (AI) and Machine Learning (ML), Geographic Information Systems (GIS), and Mobile Solutions, as advanced capabilities that can be implemented in SAP EAM.
Experience with Maximo CMMS to SAP transition, Maximo data structures, data migration, and Master Data Governance/Management.
Familiarity with Agile methodologies for software delivery and process improvement.
Professional Certifications:
SAP Certified Application Associate in SAP S/4 Hana Equipment Asset Management (preferred)
Agile Certified Practitioner (preferred)
Soft Skills:
Strong analytical and problem-solving abilities.
Excellent communication and collaboration skills.
Ability to work effectively with cross-functional teams and stakeholders.
Detail-oriented with a focus on accuracy and compliance.
What you can expect from 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. 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.
.
Salary Range
115,058.00 USD - 143,472.00 USD
Auto-ApplyDirector of External Research & Development
Remote
Career CategoryBusiness DevelopmentJob 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.
Director of External Research & Development - Technology Business DevelopmentWhat you will do
Let's do this! Let's change the world! In this vital role you as the Business Development Director within the External R&D Technology group, this role is responsible for leading Amgen's search and evaluation, as well as negotiate and execute on certain transactions, for external partnerships focusing on small molecule drug discovery, as well as technologies that support oncology therapeutic area. Collaborating with cross-functional teams to ensure alignment with the business's broader goals will also be a critical part of your role.
The successful candidate will contribute to and execute on Amgen's external strategy and develop and nurture a global network of key industry and academic contacts to ensure robust communication of ideas, interests and information between the external community and internal groups.
The role requires proactive efforts to manage the search and identification of opportunities through networking and reviews of the external landscape and prioritizing based on Amgen's R&D strategy. The role includes leading the technical evaluations of opportunities by creating and managing cross-functional review teams, providing recommendations based on robust scientific and drug industry knowledge, and ensuring appropriate and efficient decision-making processes. This person will ensure efficient reviews and engage in business negotiations, and working with the legal team to execute contractual agreements for certain projects. The candidate will be responsible for leading strategic discussions and presentations, collaborating closely with senior management, R&D, and other functions to develop a set of priorities for collaboration, license, or M&A of external innovation. The Director of External Research & Development - Technology Business Development will also be expected to contribute in search and evaluation and transactions for technology areas outside of small molecule drug discovery and oncology, as needs arise, as well as mentor others and present himself/herself as a thoughtful and respected professional to both internal colleagues and external parties.
It's highly preferred that this role be located at an Amgen Research hub in either South San Francisco, CA or Thousand Oaks, CA to match most of our research teams.
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The Director of External Research & Development - Technology Business Development will have these qualifications.
Basic Qualifications:
Doctorate degree in a scientific field & 4 years of experience in drug development industry and/or biopharma business development
Or
Master's degree in a scientific field & 7 years of experience in drug development industry and/or biopharma business development
Or
Bachelor's degree in a scientific field & 9 years of experience in R&D and/or biopharma business development
Preferred Qualifications:
Doctorate in scientific field, with strong knowledge in discovery and technology platforms
4+ years of management and/or leadership experience in business and drug development activities, and strong technical R&D experience along with business development and licensing experience.
Strong leadership, scientific, organizational, communication, and project management skills and ability to manage multiple projects simultaneously.
Excellent presentation skills. Effective communication skills pertaining to scientific and business development. Must demonstrate ability to foresee and solve problems, and prioritize and meet deadlines. Strong team player, experience in successfully managing direct reports and a demonstrated ability to interface effectively with all-levels of staff across differing functional expertise.
Demonstrated ability to create and establish relationships with internal and external parties.
Professional demeanor with strong decision making
Be able to work independently, manage large cross functional teams, and mentor individuals.
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
194,497.00 USD - 230,061.00 USD
Auto-ApplySr. Field Clinical Engineer - Shockwave Medical
Santa Clara, CA jobs
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at *******************
Job Function:
R&D Operations
Job Sub Function:
Clinical/Medical Operations
Job Category:
Professional
All Job Posting Locations:
Santa Clara, California, United States of America
Job Description:
Johnson & Johnson is hiring for a Senior Field Clinical Engineer - Shockwave Medical to join our team. This role is fully remote.
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at *******************/.
Fueled by innovation at the intersection of biology and technology, we're developing the next generation of smarter, less invasive, more personalized treatments. Ready to join a team that's pioneering the development and commercialization of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease. Our Shockwave Medical portfolio aims to establish a new standard of care for medical device treatment of atherosclerotic cardiovascular disease through its differentiated and proprietary local delivery of sonic pressure waves for the treatment of calcified plaque.
The Sr. Field Clinical Engineer is responsible for the development and execution of site-specific recruitment strategies that result in meeting enrollment targets for Shockwave Medical clinical trials. In addition, the Sr. Field Clinical Engineer will provide case support on Shockwave Medical products including Reducer and intravascular lithotripsy (IVL). The Sr. Field Clinical Engineer will play a critical role in clinical studies including device training, case support, and ensuring timely data collection for clinical programs. This work is accomplished with oversight, requires contact with internal stakeholders, frequent travel to clinical trial sites, works closely with physician advisors, and is critical to business success.
Essential Job Functions
* Physician and hospital staff training, and procedural case coverage to ensure the safe and effective use of medical devices.
* Present clinical study training materials based on investigational plans to support the safe and effective use of medical devices, including study protocol, instructions for use, core lab manuals and case report forms.
* Provide clinical and technical support for key study investigators and clinical leaders at assigned sites.
* Partner with other clinical research colleagues to meet business needs in the field including study start-up, site training, data collection for timely database locks and resolution of critical issues.
* Administrative activities including training to procedures at site level.
* Collaborate effectively with internal stakeholders (Clinical Affairs, Medical Affairs, Marketing and Medical Education) and external parties (vendors and physician advisors) to ensure Shockwave Medical clinical trials meet established enrollment goals.
* Collaborate with internal and external stakeholders to develop a repository of recruitment/study awareness materials and tools.
* Collaborate with internal and external stakeholders to ensure site-specific recruitment plans are implemented and progress tracked.
* Develop and maintain strong relationships with site investigators and research staff to understand site recruitment and enrollment processes and resolve obstacles to enrollment to meet study goals.
* Partner with assigned physician advisors to create and deliver recruitment strategies.
* Partner with vendors that support recruitment activities.
* Other duties as assigned.
Requirements
* Bachelor's Degree in a scientific field of study or equivalent work experience.
* Minimum of 5 years of relevant experience with at least 3 years of experience directly supporting interventional or surgical procedures within a hospital.
* Knowledge and experience in supporting device pre- and/or post-market clinical studies is required including experience running investigational device exemption (IDE) trials.
* Thorough knowledge of Good Clinical Practice (GCP) is required.
* Ability to attain and maintain hospital credentials.
* Ability to work in a fast-paced environment while managing multiple priorities.
* Operate as a team and/or independently while demonstrating flexibility to changing requirements.
* Experience with electronic data capture (EDC) systems.
* Must have excellent verbal and written communication skills.
* High attention to detail and accuracy.
* Able to manage multiple project teams with guidance
* Proficient computer skills (Microsoft Word, Excel, PowerPoint, etc.)
* Must be able to travel approximately 80% mostly in the US and Canada, and potentially outside North America.
* May be required to lift up to 25 pounds.
Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, please contact us via *******************/contact-us/careers or contact AskGS to be directed to your accommodation resource.
Required Skills:
Preferred Skills:
Analytical Reasoning, Business Behavior, Clinical Operations, Clinical Research and Regulations, Clinical Trial Designs, Coaching, Communication, Ethical and Participant Safety Considerations, Innovation, Laboratory Operations, Office Administration, Preclinical Research, Problem Solving, Project Management, Project Scheduling, Research and Development, Study Management
The anticipated base pay range for this position is :
US $106,250 - $143,750 / Bay Area - $122,400 - $ 165,600
Additional Description for Pay Transparency:
Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. Subject to the terms of their respective plans, employees are eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)). This position is eligible to participate in the Company's long-term incentive program. Subject to the terms of their respective policies and date of hire, Employees are eligible for the following time off benefits: Vacation -120 hours per calendar year Sick time - 40 hours per calendar year; for employees who reside in the State of Washington -56 hours per calendar year Holiday pay, including Floating Holidays -13 days per calendar year Work, Personal and Family Time - up to 40 hours per calendar year Parental Leave - 480 hours within one year of the birth/adoption/foster care of a child Condolence Leave - 30 days for an immediate family member: 5 days for an extended family member Caregiver Leave - 10 days Volunteer Leave - 4 days Military Spouse Time-Off - 80 hours Additional information can be found through the link below. *********************************************
Auto-ApplySenior Scientist - Research Computational Biology (ARIA)
Remote
Career CategoryResearchJob 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.
Senior Scientist - Research Computational Biology (ARIA)
What you will do
Let's do this. The ARIA Computational Biology team is seeking a talented and creative computational biologist to further our mission of serving patients by advancing and replenishing the Amgen therapeutic pipeline. In this role you will apply your expertise in data science and disease biology to accelerate the identification, prioritization, and validation of transformative therapeutic targets in a dynamic cross-functional research environment.
Focus areas include:
Extracting biological insight from complex multi-modal omics and screening data to characterize disease endotypes and mechanisms, identify novel targets and biomarkers, and test therapeutic hypotheses.
Developing and leveraging methods/platforms to discover, prioritize, and validate targets across diverse diseases and therapeutic modalities
Innovative research in close partnership with Amgen therapeutic area scientists, spanning both internal pipeline programs and external partnerships.
Partnering with our data science and information systems teams to incorporate tools and analyses developed within ARIA Computational Biology into integrated R&D platforms.
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 computational biologist with these qualifications.
Basic Qualifications:
Doctorate in computational biology, bioinformatics, data science, or a related discipline [and relevant post-doc where applicable]
Or
Master's degree and 3 years of relevant research experience
Or
Bachelor's degree and 5 years of relevant research experience
Preferred Qualifications:
Strong programming skills (Python, R, Linux/Unix), familiarity with cloud computing environments, HPC, and collaborative coding practices (e.g., Git).
Track record of designing and implementing creative and holistic computational strategies to address challenging research questions.
Demonstrated expertise in the analysis and interpretation of single cell omics data.
Excellent presentation and communication skills to convey complex findings to diverse audiences.
Self-starter with a collaborative mentality and a drive for continuous growth.
Strong background in cardiometabolic disease and/or immunology, including application to the interpretation of single-cell data.
Experience leveraging and fine-tuning transcriptional foundation models, LLMs, and biomedical knowledge graphs to further research goals.
Familiarity with public data resources (e.g. DepMap, Human Cell Atlas, TCGA, GTEx, and Tahoe-100M) frequently used to augment analyses of internally generated data.
Experience developing and deploying tools and pipelines to endpoints such as interactive portals (e.g. RShiny apps), workflow management systems (e.g Nextflow), and agentic frameworks.
What you can expect from 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. 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.
.
Salary Range
132,494.00 USD - 163,875.00 USD
Auto-ApplyR&D Clinical Pharmacology Modeling & Simulation - Grad Intern
Remote
Career CategoryCollege JobJob DescriptionJoin Amgen's Mission of Serving Patients
At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do.
Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.
Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.
R&D Clinical Pharmacology Modeling & Simulation - Grad Intern
What You Will Do
Let's do this. Let's change the world. During this program, you will explore the applicability and impact of different types of mathematical/pharmacological models for modeling safety and efficacy of various disease treatments. This opportunity provides the intern with projects that involve
Crafting baseline models to benchmark performance in estimation and prediction in disease models
Building appropriate modules/software scripts and associated visualizations to assess validity and performance of models
Extending/Improving the model capabilities to increase performance in estimation and prediction
What We Expect of You
We are all different, yet we all use our unique contributions to serve patients. . The motivated individual we seek is a team player with these qualifications:
Basic Qualifications:
Amgen requires that all individuals applying for a grad internship at Amgen must meet the following criteria:
18 years or older
Graduated with a bachelor's degree from an accredited college or university
Currently enrolled in an MBA program for an MBA internship OR a Master's program for a Master's internship OR a PharmD program for a PharmD internship OR Ph.D. for a PhD internship from an accredited college or university and completion of the first year of MBA OR Master's OR Pharm D OR Ph.D. program before the internship starts
Enrolled in an accredited college or university following the potential internship
Must not be employed at the time the internship starts
Student must be located in the United States for the duration of the internship
Preferred Qualifications:
Pursuing a PhD or PharmD in the pharmaceutical sciences, statistics, engineering or bio-mathematics discipline
Has inquisitive mind and interest and passion for modeling biological data
Has exposure to pharmacological models/clinical trial data
Has sound knowledge of ordinary differential equations systems and modeling
Has proficiency in R/Python/NONMEM.
Exposure to the biology of cancers/rare diseases a plus
What You Can Expect of Us
As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way.
The base pay range for this opportunity in the U.S. is $30-$40 per hour
Build a network of colleagues that will endure and grow throughout your time with us and beyond.
Bring your authentic self to the table and become the professional you're inspired to be through accepting a culture that values the diversity of thought and experience and will flex to your strengths and possibilities.
Participate in executive and social networking events, as well as community volunteer projects.
Apply now and make a lasting impact with the Amgen team. careers.amgen.com - Please search for Keyword R-231137
In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.
Sponsorship
Candidates must be authorized to work in the U.S. for the duration of this program. Sponsorship for future FTE roles is not guaranteed.
As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
.
Salary Range
-
Auto-ApplyGlobal Marketing Sr Manager - Oncology
Remote
Career CategoryMarketingJob 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.
Global Marketing Senior Manager
What you will do
Let's do this. Let's change the world. In this vital role you will require a strong ability to collaborate cross-functionally with other Amgen business units.
In this role you will be responsible for the following:
Partnering with your Director and other Leaders to define Amgen's early oncology pipeline commercial strategy to ensure investments in research and early development align with long-term business objectives and patient needs.
Developing commercial frameworks and business cases to inform progression decisions for early-stage assets (PT through E2L Portals), integrating insights from market dynamics, patient needs, and competitive intelligence.
Contributing to a best-in-class commercial function for oncology early pipeline strategy, ensuring Amgen maintains a leadership position in bringing first-in-class and best-in-class therapies to market.
Key activities and accountabilities include the following:
Early Pipeline Strategy & Portfolio Prioritization
Create and leverage frameworks for evaluating and prioritizing early-stage oncology assets.
Support the assessment of commercial viability and differentiation of assets in early development, ensuring alignment with evolving market needs and payer landscapes.
Preparation of business cases along with other execution-based deliverables to business needs.
Commercial Partnership with Research & Early Development
Provide commercial input to research-stage investment decisions, ensuring a clear path to differentiated and commercially viable products.
Collaborate with R&D to develop target product profiles (TPPs) that reflect strong commercial positioning.
Establish strong cross-functional partnerships with R&D, corporate strategy, finance, and global marketing teams.
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The . The dynamic professional we seek is a self-starter with these qualifications.
Basic Qualifications:
Doctorate degree and 2 years of Marketing experience
Or
Master's degree and 4 years of Marketing experience
Or
Bachelor's degree and 6 years of Marketing experience
Or
Associate's degree and 10 years of Marketing experience
Or
High school diploma / GED and 12 years of Marketing experience
Preferred Qualifications:
5+ years of biotech/pharmaceutical industry experience with strong experience in strategy development/consulting, and multiple facets of drug commercialization
Oncology therapeutic area experience (marketing and/or scientific) with recognized depth in industry, technical and competitive dynamics that shape future oncology markets and needs
Strong interpersonal skills with demonstrated ability to work and influence effectively within a matrix structure.
Demonstrated ability to work with cross-functional partners to develop impactful program strategies that are based on market insights
Knowledge of and experience in working with discovery research and clinical teams.
Strong leadership skills, including ability to influence teams with diverse backgrounds.
Strong competitive mindset, including ability to champion ideas, make decisions and focus on results
Strong business judgment and emotional intelligence
Act as a role model for others in line with Amgen values
The DASL position is complex and demanding. The preferred candidate is a strong commercial executive with excellent marketing capabilities, strong analytical skills, superior cross-functional collaboration skills, the ability to operate globally and locally, and highly effective influencing skills. Success in this critical role will result in significant professional growth and advancement at Amgen.
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
Sponsorship
Sponsorship for this role is not guaranteed.
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.
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
152,006.00 USD - 178,530.00 USD
Auto-ApplyAssociate Compensation & Benefits Tax Counsel
New Brunswick, NJ jobs
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at *******************
**Job Function:**
Finance
**Job Sub** **Function:**
Tax
**Job Category:**
Professional
**All Job Posting Locations:**
New Brunswick, New Jersey, United States of America
**Job Description:**
Johnson & Johnson is seeking an experienced **Associate Compensation & Benefits Tax Counsel.** This role is located in New Brunswick, New Jersey.
This position reports to the VP Compensation & Benefits Tax Counsel. The candidate will provide high level technical tax and legal advice to management in the administration of the company's worldwide employee compensation and benefit plans.
Incumbent is responsible for ensuring compliance with laws and regulations applicable to employee compensation and benefits. Specifically, incumbent will advise management regarding tax and legal requirements in areas including qualified retirement plans, stock based compensation, employee welfare benefit plans, employee fringe benefits, mergers, acquisitions & divestitures, plan asset investments, and executive compensation matters. The Associate Compensation & Benefits Tax Counsel will also advise on payroll withholding and reporting matters and other global employee compensation and benefits matters.
Remote work options may be considered on a case-by-case basis and if approved by the Company.
**Position Requirements:**
+ A Juris doctor degree from an accredited law school is required.
+ A minimum of one active state (or District of Columbia) bar admission is required.
+ A minimum of 10 years of experience at a law firm, accounting firm and/or major corporation advising clients or management on a wide variety of employee compensation & benefits tax and legal matters is required.
+ Working knowledge of the provisions of the Internal Revenue Code applicable to the taxation of employee compensation and benefits and of the Employee Retirement and Security Act of 1974 (ERISA) is required.
+ Experience advising on compensation and benefits matters in mergers, acquisition, and divestiture transactions is required.
+ Experience advising on plan asset investment matters is required.
+ Incumbent will also require excellent business partnering and communication skills - specifically the ability to communicate highly technical matters to management whose knowledge may be more general.
Preferred Requirements/Competencies:
+ Exposure to and general knowledge of the laws of some major non-U.S. jurisdictions with respect to employee compensation and benefit matters, reporting and withholding, and employee location compliance are preferred.
▪ The expected base pay range for this position is $173,000 to $300,000.
- The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation's performance over a calendar/performance year. Bonuses are awarded at the Company's discretion on an individual basis.
Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short and long-term disability, business accident insurance, and group legal insurance.
▪ Subject to the terms of their respective plans, employees are eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)).
▪ This position is eligible to participate in the Company's long-term incentive program. 6
▪ Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:
- Vacation - 120 hours per calendar year
- Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado -48 hours per calendar year; for employees who reside in the State of Washington -56 hours per calendar year
-Holiday pay, including Floating Holidays -13 days per calendar year
- Work, Personal and Family Time - up to 40 hours per calendar year
-Parental Leave - 480 hours within one year of the birth/adoption/foster care of a child
- Bereavement Leave - 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
- Caregiver Leave - 80 hours in a 52-week rolling period 10 days
- Volunteer Leave - 32 hours per calendar year
- Military Spouse Time-Off - 80 hours per calendar year
Additional information can be found through the link below.
For additional general information on Company benefits, please go to: - *********************************************
**Required Skills:**
**Preferred Skills:**
Agility Jumps, Audit Management, Consulting, Critical Thinking, Fiduciary Liability, Financial Analysis, Financial Reports, Financial Risk Management (FRM), Financial Trends, Leadership, Organizing, Process Optimization, Program Management, Tax Advising, Tax Compliance, Tax Management, Transparency Reporting
**The anticipated base pay range for this position is :**
173000-300000
Additional Description for Pay Transparency: