Clinical Program Manager
Iqvia job in Parsippany-Troy Hills, NJ
We are looking for Senior Project Leaders/Clinical Program Managers to join our innovative and dynamic group of global professionals dedicated to assisting our clients in driving healthcare forward. This is an important and high-profile role within our sponsor-dedicated business unit to enable medical breakthroughs that advance healthcare and patient treatment options around the world.
As Senior Project Leader/Clinical Program Manager you will liaise directly between IQVIA/sponsor functions and the customer, acting as that accountable point for delivery and quality whilst maintaining financial control. You will manage cross functional teams across this global organization and be supported by domain experts in every function, enabled by best-in-class technology and data analytics. This role owns study and or program level timelines and planning;
Microsoft Project (MSP) expertise is a must-have, as well as developed analytic skills.
Key collaborators are the Clinical Lead for site management, the Project Vendor Manager, the Project Management Analyst for project coordination, tracking and financial analysis, and the Site Activation Manager an expert in start-up.
IQVIA's size and global footprint will present you with the breadth of opportunities necessary to develop your career.
**Typically assigned to one or two projects, or a program, responsibilities might include:**
+ Leading global cross-functional project team delivery, accountable for achievement of milestones and quality of contracted scope
+ Serving as the primary contact with the customer for progress and governance
+ Developing study management plans and ensuring consistent use of study tools, training materials and compliance with standard processes, policies and procedures
+ Anticipating risk and implementing mitigation strategies
+ Managing study team assignments, accountability and resource requirements
+ Ensuring the study budget is managed proactively including scope changes and financial systems are accurate
**Requirements:**
+ Bachelors Degree
+ Professional Project Management certification is preferred
+ A minimum of 5 years' in Clinical Project Management in industry/CRO/business experience is required in clinical drug development
+ and/or clinical operations, clinical R&D experience preferred.
+ Prior experience leading a cross-functional global teams is required
+ Demonstrated ability to resolve conflict and influence teams without direct authority
+ Successful experience in planning and management of governance bodies is preferred
+ Proficient in MS Project is required
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at **********************
IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law. **********************/eoe
The potential base pay range for this role, when annualized, is $93,100.00 - $285,500.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide.
To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us.
EEO Minorities/Females/Protected Veterans/Disabled
VP, GM Tech-Enabled Sales Outsourcing
Iqvia job in Parsippany-Troy Hills, NJ
, you must reside in the same country where the job is located.
The General Manager for our Contract Sales practice will be primary responsibility for the client impact, profitability and growth of inside sales and field sales outsourcing; business is today roughly $160M in revenues. The GM will have responsibility and leadership role to maintain and grow the business revenue, diversifying the client base and methods by which we serve them; and to drive analytic-enablement innovations and efficiencies that drive multiple margin expansion opportunities, as well as opportunities across our Healthcare Provider (HCP) Activation capabilities.
In addition to the standard GM responsibilities for financial and team management, sales & marketing strategies; the role is intended to be directly client facing, in building transformative client partnerships to improve their most critical business levers; and market-facing, in building collaborations with third parties that enhance our value proposition to clients, and our impact at clients. To perform those roles well, the GM will also be responsible for shaping and leading the analytic -enablement strategy of the business.
Drive top line sales and revenue by:
Drive Revenue to Plan of 162.6 and TCV to Plan of 212.5m
Establish and execute a strategy for increasing sales and revenue in the short and long term, at the individual segment level.
Oversee development of targeting prioritization and execution against targets
Responsible for sales & marketing strategy across account segments and throughout the brand life cycle
Partner with other Centers of Excellence and Business lines to advance cross-portfolio offerings including data, analytics, digital, brand, and technology.
Incorporate the use of analytics to support our therapy expertise and delivery strategy.
Develop new offerings to continually maintain industry leadership, anticipating and adapting to new industry norms
Demonstrate leadership and subject matter expertise during client presentations to impact win rate.
Ensure delivery success and positive client satisfaction.
Drive bottom line profitability by:
Manage expenses and drive profit growth.
Working with operations to support clients effectively, including recruiting, training, project management, etc.
Drive Lean initiatives to reduce operating costs, meeting savings targets on an annual basis
Manage compliance and performance to avoid potential challenges.
Manage the overall practice through:
Owns P&L and financial target responsibilities for the business
Delivers on our high standard for people development and the EVP
Responsible for overall client impact and satisfaction
Develops and executes the short- and long-term operating plans and strategies for the segment and ensures consistency with corporate and RBU objectives
Creates and maintains a positive working relationship with third party collaborators and our clients' other partners
Communicates and collaborates with the extended RBU LT to shape and deliver business strategy, innovations, and client delivery
Leverage subject matter expertise to develop thought leadership and innovation in the market, including novel methods of measuring engagement success
Build and refine client materials, including case studies.
Establish and maintain pricing structures.
Maintain a repository of client references.
Create offerings that support client use cases
Partner with other leaders throughout the organization building integrated offerings leveraging analytics, methodologies, and technologies.
Develop opportunities to expand capabilities
Analyze and implement technology infrastructure and digital solutions in order to support the continued growth of these solutions. Identify and build business cases for investment.
Identify and execute partnership and acquisition strategies as appropriate to meet long term objectives, manage acquisitions as needed.
Provide leadership to the extended team including building culture, providing regular communications, setting clear expectations and reinforcing a high performance culture expectation.
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at **********************
IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law. **********************/eoe
The potential base pay range for this role, when annualized, is $211,700.00 - $589,700.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.
Auto-ApplyLingo Sales Representative - New York City & North New Jersey
Newark, NJ job
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries.
Lingo Sales Representative
Working at Abbott
At Abbott, you can do work that matters, grow, and learn, care for yourself and your family, be your true self, and live a full life. You'll also have access to:
* Career development with an international company where you can grow the career you dream of.
* Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
* An excellent retirement savings plan with a high employer contribution
* Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit - an affordable and convenient path to getting a bachelor's degree.
* A company recognized as a great place to work in dozens of countries worldwide and named one of the most admired companies in the world by Fortune.
* A company that is recognized as one of the best big companies to work for as well as the best place to work for diversity, working mothers, female executives, and scientists.
The Opportunity
The Lingo Division has an opportunity for a Sales Representative in the New York City & North New Jersey Area.
Lingo is a new biosensing technology that provides users a window into their body. Lingo tracks key biomarkers - such as glucose, ketones, and lactate - to help people make better decisions about their health and nutrition. Biowearable technology will digitize, decentralize, and democratize healthcare, enabling consumers to take control of their own health.
The primary responsibility of this role is to drive sales by securing commitments for recommendations from Healthcare Professionals in various offices including Internal Medicine, Primary Care, Concierge Practices, Dieticians, Longevity/Functional Medicine Practices, and MedSpas. Typical call points within these offices include: Physicians, Nurses, Medical Assistants, Administration, and Nutrition Services. Responsible for creating and maintaining relationships within these offices to effectively elevate the importance of Lingo by identifying and providing win-win solutions for using Lingo products. In addition to obtaining commitments for recommendations, it is also vital in this role to hold customers accountable and ensure compliance.
What You'll Work On
* Execute sales initiatives designed to exceed established sales goals for Lingo
* Work closely with Lingo Sales Leader and cross-functional / interdisciplinary teams to execute the sales direction
* Identify customer needs and deliver on sales opportunities accordingly
* Utilize Lingo promotional materials to targeted healthcare professionals
* Prioritize the utilization of resources to drive return on investment
* Plan and organize to maximize focus on top priorities
Territory
* The ideal candidate will be based in the New York City & North New Jersey Area
* 5-10% overnight travel for Regional/National meetings and trainings
* This position does not offer relocation. Local candidates only, please.
Key Competencies
* Persistence
* Persuasiveness
* Strong initiative
* Results-Oriented / Will to win
* Strategic planning and execution
* Identify and prioritize call points
* Adaptability and coachability
* Sales and learning agility
* Integrity
Required Qualifications
* Bachelor's Degree required
* 1-3 years of sales experience preferred
* B2B, Cold-Calling, Outside selling experience
* Experience building own book of business
* Wearable, fitness, nutrition, and medical device knowledge is preferred but not required
* Strong business acumen
Apply Now
Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: **********************
Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.
Connect with us at *************** on Facebook at ************************ and on Twitter @AbbottNews.
The base pay for this position is $60,000.00 - $120,000.00. In specific locations, the pay range may vary from the range posted.
Auto-ApplyAssoc Director, Patient Safety Medical Device Safety
Parsippany-Troy Hills, NJ job
At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.
Every member of Gilead's team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we're looking for the next wave of passionate and ambitious people ready to make a direct impact.
We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.
Job Description
Patient Safety is seeking a dynamic and experienced individual to join the Patient Safety Strategic Operations team as an Associate Director, Patient Safety Medical Device Safety responsible for supporting activities to ensure ongoing safety oversight of Gilead's medical devices and combination products throughout the product lifecycle. These activities include but are not limited to ensuring compliant global processes for vigilance/safety reporting, post-market surveillance system, trending of device complaints, risk management, and analysis of safety data sets covering Gilead medical device and combination product portfolio. This role will help drive strategies and ensure operational excellence through successful business partner collaboration.
The Associate Director, PS Medical Device Safety will be a medical device / combination product expert who supports safety oversight and provides technical contributions to design control, risk management, clinical evaluations, vigilance/safety reporting, post-market surveillance and trending / signal management for medical devices and combination products worldwide. The role would suit someone with passion for patient safety, strong strategic thinking, communication and analytical skills, broad PV and medical device / combination product experience and an enthusiasm for understanding the business needs.
Key Responsibilities
Responsibilities include, but are not limited to:
Ensure safety processes are executed and maintained throughout the product lifecycle in compliance with relevant regulations, standards, and guidelines for medical devices, combination products and diagnostics.
Review device cases / complaints to ensure that case processing and evaluation are accurate and in compliance with regulatory requirements for safety reporting and Gilead standards. Closely collaborate with ICSR and Product Complaint teams to resolve any issues, inconsistencies or inaccuracies identified between the Global Safety database and Quality database.
Develop training and standards for case processing and safety reporting.
Contribute to medical device / combination product Post-Market Surveillance (PMS), including planning and report preparation. Support writing, review, and submission of applicable device contribution in aggregate reports (PSUR/PBRER, PADER).
Collaborate with PS Therapeutic Area leads and PS Benefit-Risk Science teams to conduct safety assessments of data sets including device complaints, as well as device trending and signal management for combination products.
Provide device safety contribution and collaborate with PS Therapeutic Area leads in combination product development and clinical studies.
Collaborate with cross-functional team in device risk management activities including identification and reduction of risks associated with Gilead's medical devices / combination products, conducting benefit-risk analysis, and evaluating overall residual risk acceptability throughout the lifecycle of the product.
Review regulatory intelligence and work with PS cross functional team to interpret, assess impact, and update processes and procedures with regards to device / combination product regulations requirements and updates as required.
Collaborate with PS Affiliate leads regarding local regulatory requirements and coordinate globally.
Represent PS in cross functional working groups and teams with regards to device / combination product / diagnostic regulations and its impact to PS.
Link with PS Alliances team regarding device requirements needed in PV agreements with License Partners.
Collaborate with cross-functional teams in the preparation and/or support of internal audits and regulatory agency inspections; reviews, responds and implement corrective and preventive actions with respect to findings on PS processes for medical device / combination product.
Develop solutions to a wide range of complex problems, ensuring solutions are consistent with organization objectives.
Foster a culture of collaboration and communication to drive business objectives.
Drive a culture of continuous improvement to enhance PS processes and safety oversight.
Stay abreast of industry trends, emerging topics, and best practices in the medical device / combination product space.
Basic Qualifications
BA/BS with 10+ years' relevant experience OR
MA/MS/MBA with 8+ years' relevant experience OR
PhD/PharmD with 5+ years' relevant experience
Preferred Qualifications
Health care professional degree preferably Nursing or Biomedical Engineering degree.
Extensive medical device / combination product safety or related experience. Previous experience in pharmacovigilance and device safety activities.
Thorough understanding and application of medical device / combination product regulations and industry standards globally for design control, device risk management, vigilance / safety reporting, and post-market surveillance throughout the product lifecycle. Experience translating these requirements into medical device safety processes, in particular risk management, device vigilance / safety reporting and post-market surveillance preferred.
Significant experience in navigating a matrix organization.
Track record of successfully leading complex, large scale, time-sensitive projects.
Strong relationship building skills, and ability to collaborate, influence and negotiate to work effectively with cross-functional teams to meet project timelines and patient needs.
Excellent verbal, written, and interpersonal communication skills. Ability to write clear and concise documents/presentations.
Ability to prioritize and manage across multiple competing projects.
When needed, ability to travel.
The salary range for this position is:
Other US Locations: $177,905.00 - $230,230.00.
Bay Area: $195,670.00 - $253,220.00.
Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*.
For additional benefits information, visit:
******************************************************************
* Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.
For jobs in the United States:
Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact ApplicantAccommodations@gilead.com for assistance.
For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster.
NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT
YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT
Gilead Sciences will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, (c) consistent with the legal duty to furnish information; or (d) otherwise protected by law.
Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.
Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.
For Current Gilead Employees and Contractors:
Please apply via the Internal Career Opportunities portal in Workday.
Auto-ApplySr Specialist, Quality Systems
Parsippany-Troy Hills, NJ job
At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.
Every member of Gilead's team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we're looking for the next wave of passionate and ambitious people ready to make a direct impact.
We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.
Job Description
Job Responsibilities:
* Independently and proactively initiate and drive the planning, execution, and completion of change management projects
* Develop and implement strategies to mitigate risks within the change management process and change control system.
* Facilitate and present at cross-functional meetings with stakeholders and leadership to ensure alignment with proposed changes and compliance to QMS and regulatory expectations.
* Responsible for managing change controls related to manufacturing product, process, equipment, facility, and computerized systems contributing to the oversight of key strategic, tactical, and operational goals.
* Develop, deliver, and improve the change management program for various levels of the organization, while also ensuring training effectiveness.
* Independently review, initiate, complete, and thoroughly document critical, major, and minor change controls, managing local and global change controls and associated activities related to GxP operations.
* Navigate through complex change review discussions, facilitating to a common decision for each change regarding approach and follow-up actions to be taken, and documenting the decisions and evaluations accordingly.
* Supports management and monitoring of change records for adherence to organizational or departmental metric targets, and maintenance of associated tracking tools/databases.
* Supports management review process through development and generation of quality system metrics and trending, and escalates issues as required. In-depth evaluation will be needed.
* Work closely with Change Management Business Process Lead and business support team members to support enhancements of the change control QMS processes and business process.
* Supports the maintenance and improvement of quality systems processes, as needed.
* Works directly with operating entities and internal clients to ensure follow-up of change tasks.
* Participate in compliance audits as required.
* Maintains programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (cGMPs).
* Writes and/or implements changes to controlled documents (e.g., SOPs, Specifications, Methods, etc.) as needed. Provides guidance and technical knowledge to more junior staff, monitors the performance of daily tasks.
Knowledge:
* Demonstrates proficiency in Good Manufacturing Practices (GMPs) and/or Good Laboratory Practices (GLPs).
* Demonstrates proficiency in application of QA systems principles, concepts, industry practices, and standards, particularly related to change management.
* Demonstrates ability to effectively manage multiple complex projects and priorities simultaneously.
* Demonstrates ability to work independently
* Has proven analytical and conceptual skills. Demonstrates understanding of international quality systems regulations to adopt best in class systems/processes.
* Demonstrates excellent verbal communication, technical writing and interpersonal skills.
* Experience in Quality Management System (i.e Veeva, TrackWise, MasterControl, etc)
* Demonstrates strong proficiency in Microsoft Office applications.
Basic Qualifications:
* BS or BA 7+ years of relevant experience in a GMP environment related field
OR
* MS 5+ years of relevant experience in a GMP environment related field
People Leader Accountabilities:
* Create Inclusion - knowing the business value of diverse teams, modeling inclusion, and embedding the value of diversity in the way they manage their teams.
* Develop Talent - understand the skills, experience, aspirations and potential of their employees and coach them on current performance and future potential. They ensure employees are receiving the feedback and insight needed to grow, develop and realize their purpose.
* Empower Teams - connect the team to the organization by aligning goals, purpose, and organizational objectives, and holding them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem.
The salary range for this position is: $123,930.00 - $160,380.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*.
For additional benefits information, visit:
******************************************************************
* Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.
For jobs in the United States:
Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact ApplicantAccommodations@gilead.com for assistance.
For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster.
NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT
YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT
Gilead Sciences will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, (c) consistent with the legal duty to furnish information; or (d) otherwise protected by law.
Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.
Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.
For Current Gilead Employees and Contractors:
Please apply via the Internal Career Opportunities portal in Workday.
Auto-ApplyCRA 2, CAR-T, IQVIA Biotech
Iqvia job in Parsippany-Troy Hills, NJ
**_IQVIA Biotech is now hiring for CRA 2 with a minimum of 1 year of on-site monitoring and experience working in CAR-T._** _IQVIA Biotech is a full-service CRO purpose-built to serve biotech sponsors. With over 25 years of experience, we offer agile, therapeutically aligned solutions and trusted partnerships that help bring breakthrough treatments to patients faster._
**Job Overview**
We are seeking a dedicated Clinical Research Associate (CRA) to join our team and play a key role in ensuring the successful execution of clinical trials. In this position, you will be responsible for monitoring and managing clinical sites to ensure compliance with study protocols, regulatory requirements, and sponsor expectations. Your work will directly contribute to the integrity and quality of clinical research data.
**Key Responsibilities**
+ Conduct all types of site visits-selection, initiation, monitoring, and close-out in alignment with the contracted scope of work, Good Clinical Practice (GCP), and ICH guidelines.
+ Collaborate with site staff to implement and track subject recruitment strategies that align with project timelines and enrollment goals.
+ Deliver protocol and study-specific training to site personnel and maintain consistent communication to manage expectations and resolve issues.
+ Assess site performance and adherence to the protocol, escalating quality concerns as needed to ensure compliance and data integrity.
+ Monitor study progress by tracking regulatory submissions, subject enrollment, case report form (CRF) completion, and resolution of data queries.
+ Ensure that essential documents are collected and maintained in both the Trial Master File (TMF) and the Investigator Site File (ISF) in accordance with regulatory standards.
+ Document site management activities, visit outcomes, and follow-up actions through detailed reports and correspondence.
+ Work closely with cross-functional project teams to support study execution and ensure alignment with project goals.
+ Depending on the project, you may also support site-level recruitment planning and financial management, including invoice collection and budget tracking.
**Qualifications**
+ Bachelor's degree in life sciences or health-related field (or equivalent experience).
+ Requires at least 1 year of on-site monitoring experience.
+ Strong understanding of GCP, ICH guidelines, and regulatory requirements.
+ Ability to travel as required by the project.
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at **********************
IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law. **********************/eoe
The potential base pay range for this role, when annualized, is $57,500.00 - $174,400.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide.
To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us.
EEO Minorities/Females/Protected Veterans/Disabled
Sr Specialist, Quality Systems
Parsippany-Troy Hills, NJ job
At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.
Every member of Gilead's team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we're looking for the next wave of passionate and ambitious people ready to make a direct impact.
We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.
**Job Description**
**Job Responsibilities:**
+ Independently and proactively initiate and drive the planning, execution, and completion of change management projects
+ Develop and implement strategies to mitigate risks within the change management process and change control system.
+ Facilitate and present at cross-functional meetings with stakeholders and leadership to ensure alignment with proposed changes and compliance to QMS and regulatory expectations.
+ Responsible for managing change controls related to manufacturing product, process, equipment, facility, and computerized systems contributing to the oversight of key strategic, tactical, and operational goals.
+ Develop, deliver, and improve the change management program for various levels of the organization, while also ensuring training effectiveness.
+ Independently review, initiate, complete, and thoroughly document critical, major, and minor change controls, managing local and global change controls and associated activities related to GxP operations.
+ Navigate through complex change review discussions, facilitating to a common decision for each change regarding approach and follow-up actions to be taken, and documenting the decisions and evaluations accordingly.
+ Supports management and monitoring of change records for adherence to organizational or departmental metric targets, and maintenance of associated tracking tools/databases.
+ Supports management review process through development and generation of quality system metrics and trending, and escalates issues as required. In-depth evaluation will be needed.
+ Work closely with Change Management Business Process Lead and business support team members to support enhancements of the change control QMS processes and business process.
+ Supports the maintenance and improvement of quality systems processes, as needed.
+ Works directly with operating entities and internal clients to ensure follow-up of change tasks.
+ Participate in compliance audits as required.
+ Maintains programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (cGMPs).
+ Writes and/or implements changes to controlled documents (e.g., SOPs, Specifications, Methods, etc.) as needed. Provides guidance and technical knowledge to more junior staff, monitors the performance of daily tasks.
**Knowledge:**
+ Demonstrates proficiency in Good Manufacturing Practices (GMPs) and/or Good Laboratory Practices (GLPs).
+ Demonstrates proficiency in application of QA systems principles, concepts, industry practices, and standards, particularly related to change management.
+ Demonstrates ability to effectively manage multiple complex projects and priorities simultaneously.
+ Demonstrates ability to work independently
+ Has proven analytical and conceptual skills. Demonstrates understanding of international quality systems regulations to adopt best in class systems/processes.
+ Demonstrates excellent verbal communication, technical writing and interpersonal skills.
+ Experience in Quality Management System (i.e Veeva, TrackWise, MasterControl, etc)
+ Demonstrates strong proficiency in Microsoft Office applications.
**Basic Qualifications:**
+ **BS or BA 7+ years of relevant experience in a GMP environment related field**
**OR**
+ **MS 5+ years of relevant experience in a GMP environment related field**
**People Leader Accountabilities:**
+ Create Inclusion - knowing the business value of diverse teams, modeling inclusion, and embedding the value of diversity in the way they manage their teams.
+ Develop Talent - understand the skills, experience, aspirations and potential of their employees and coach them on current performance and future potential. They ensure employees are receiving the feedback and insight needed to grow, develop and realize their purpose.
+ Empower Teams - connect the team to the organization by aligning goals, purpose, and organizational objectives, and holding them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem.
The salary range for this position is: $123,930.00 - $160,380.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*.
For additional benefits information, visit:
******************************************************************
* Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.
**For jobs in the United States:**
Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact ApplicantAccommodations@gilead.com for assistance.
For more information about equal employment opportunity protections, please view the 'Know Your Rights' (********************************************** poster.
NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT (*********************************************************
YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT
Gilead Sciences will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, (c) consistent with the legal duty to furnish information; or (d) otherwise protected by law.
Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.
Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.
**For Current Gilead Employees and Contractors:**
Please apply via the Internal Career Opportunities portal in Workday.
Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.
Scientific Director, Medical Communications
Iqvia Holdings Inc. job in Jersey City, NJ
eNova, an IQVIA business, is a next-generation medical communications agency. Our mission is to transform medical communications by connecting HCPs and stakeholders across the healthcare ecosystem with content that advances science and medicine.
We are currently seeking a talented Scientific Director to join our team in support of both new and existing client engagements. The Scientific Director will be responsible for the planning, development, and oversight of scientific content within their assigned portfolio. While we work across therapeutic areas, the ideal candidate for this role will bring experience in rare, nephrology, rheumatology, and other inflammatory disease areas.
Primary Responsibilities
* Develop and/or oversee development and implementation of scientific communications projects, ensuring alignment with medical strategy and client objectives
* Serve as medical lead and trusted resource for assigned accounts/projects
* Demonstrate expert knowledge in the brand/therapeutic area and proficiency in shaping medical strategy, providing guidance to both internal and external stakeholders
* Serve as primary lead for content development, including serving as primary writer, as well as working with medical writer/junior team member
* Participate in MLR review meetings, with ability to discuss and interpret comments, and incorporate and/or direct changes as appropriate
* Participate in faculty calls, demonstrating strong understanding of the product and relevant therapeutic area
* Liaise with clients and build relationships to support business growth
* Participate and contribute to strategic planning on assigned accounts
* Work closely with various team members to ensure timely delivery of documents at each phase of development
* Assist in new business development by conducting background research and contributing to the preparation of new business proposals
* Collaborate with account partners to efficiently manage project execution and MLR submissions, including the preparation of annotated documents for seamless handoff to the submissions team
Qualifications
* Advanced degree: PharmD, MD, or PhD is required.
* 5+ years of relevant experience in promotional medical education such as advisory boards, speaker programs, speaker trainings, slide decks, etc.
* Experience working with both print and digital assets.
* Excellent verbal/written communication skills and organizational skills
* Ability to develop and maintain strong relationships with internal and external stakeholders
* Proficiency in the use of Microsoft Office products
* Familiarity with the Veeva submission processes is a plus
* Excellent time management and organizational skills
* Ability to complete multiple tasks and manage a high volume of work
* Proactive nature and can work with little supervision
* Some travel may be required
Please Note: You must reside within the country where this position is posted in order to be eligible for this remote role.
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at **********************
IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law. **********************/eoe
The potential base pay range for this role, when annualized, is $95,100.00 - $237,700.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.
Join a Ground-Breaking AI Initiative at IQVIA - Expression of Interest
Iqvia Holdings Inc. job in Parsippany-Troy Hills, NJ
IQVIA is assembling a world-class team to create large-scale AI solutions, leveraging cutting-edge machine learning architectures. Our mission is to integrate data across clinical, real-world, and biomedical sources, unlocking new insights into patient trajectories and transforming how we understand and anticipate health outcomes.
We are still in the very early stages of planning this pioneering initiative, but we are beginning to build a pipeline of exceptional talent to support this transformative work.
We are inviting expressions of interest from individuals with expertise in the following areas:
* Go-to-Market & Partnerships: Strategic leaders to drive consortium engagement and early-stage offering development.
If you're excited by the idea of shaping something from the ground up and want to be considered when roles formally open, we'd love to hear from you.
Note: This is an early-stage talent pooling effort. We are not actively interviewing at this time, but we welcome your interest and will be in touch as the project progresses.
Please note: Due to anticipated urgency once roles are approved, we are unable to offer visa sponsorship for these positions. Candidates must already have the legal right to work in the relevant country.
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at **********************
IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law. **********************/eoe
The potential base pay range for this role, when annualized, is $92,300.00 - $230,000.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.
Mobile Medical Assistant/Phlebotomist-Per Diem In-Home Services
Iqvia job in Hoboken, NJ
Mobile Medical Assistant / Phlebotomist - Per Diem, In-Home Services
About the Role: IQVIA's In-Home Clinical Solutions team seeks a qualified and dedicated Mobile Medical Assistant / Phlebotomist to support patient care by delivering in-home diagnostic services. This per diem role involves traveling to patient residences to perform clinical services such as, but not limited to, phlebotomy, electrocardiograms (EKGs), and macular edema screenings in support of treatment initiation and adherence strategies.
This is a per diem, travel-based role offering flexible hours, with no minimum monthly visit requirement. Referrals are assigned based on your geographic availability and program demand. IQVIA manages all scheduling and patient communication, allowing you to focus entirely on clinical care.
Position Details:
Per diem, mobile-based role with flexible scheduling
No minimum monthly visit commitment required
Paid hourly compensation that includes the appointment time and travel time to/from patient's home. (2 hour minimum paid)
IRS-standard mileage rate reimbursement.
Key Responsibilities:
Perform in-home blood specimen collection, labeling, and transporting specimens according to network policies, procedures, and regulatory standards.
Comply with all laboratory safety and handling procedures; ensure appropriate delivery to designated laboratories.
Conduct screenings as has been appropriately trained to conduct, including but not limited to electrocardiograms (EKGs) and macular edema screening exams (training provided).
Maintain a clean and organized work environment, including transportation and supplies storage specific to the In-Home Network.
Monitor and manage clinical supply inventory.
Collaborate with IQVIA's clinical coordination team to execute and submit appropriate visit-related paperwork promptly and accurately.
Identify and report adverse events, medical product complaints, or patient inquiries in accordance with IQVIA and manufacturer guidance.
Maintain accurate mileage and time logs for reimbursement and compliance purposes.
Qualifications:
Minimum 2 years of phlebotomy experience in clinical or field settings required
At least 1 year of EKG experience preferred
Certification as a Certified Medical Assistant (CMA) or Phlebotomy Technician (CPT) preferred.
If located in the state of Washington or Louisiana, a state issued CMA or CPT license is required.
Ability to lift up to 50 pounds to transport medical or diagnostic equipment (e.g., eye exam kits).
Ability and willingness to travel up to 100 miles to conduct patient visits.
Proficiency in using medical equipment and upholding proper documentation practices.
Strong interpersonal and communication skills with a patient-focused approach.
Fluent in spoken and written English.
Must possess a valid driver's license and will be subject to a review of driving record prior to hire.
Must complete a drug screening and background check after accepting an offer.
#LI-CES
#LI-DNP
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at **********************
IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law. **********************/eoe
The potential base pay range for this role is 25.00 per hour. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.
Auto-ApplyPhysician Assistant Clinical Specialist - New York/Philadelphia
Iqvia job in New York, NY
Join the IQVIA team, where diversity and inclusion thrive in a workplace committed to improving patients' lives. We recognize that our employees are crucial to our mission's success and have been acknowledged as a fantastic workplace. At IQVIA, we provide benefits and programs to empower you to develop and advance in your career. We are particularly interested in attracting individuals with drive and initiative, individuals who are ready to propel their careers forward and contribute to driving performance.
As a global leader in commercial solutions, IQVIA is dedicated to delivering impact both nationally and internationally. Our collaborative teams play a vital role in ensuring that biopharmaceuticals, medical devices, and patient support services reach those who need them. We offer valuable insights to customers and demonstrate product value to payers, physicians, and patients. Whether acting as a sales force to physicians or providing education to patients or prescribers, you can contribute to delivering real-world medical breakthroughs with the right experience. Explore the possibilities and be part of shaping a healthier future with us.
We are hiring a Physician Assistant Clinical Specialist for a leading medical device manufacturer. This position involves observing surgeries, educating clinical and sales teams on surgical products to provide procedural knowledge and product suggestions. The specialist must reside in the assigned region and be a Certified Physician Assistant with expertise in Urology, ENT, Plastics, Emergency Medicine, ED, OB/GYN, Pediatrics, with a minimum of 7 years' operating room experience. This is a full-time role.
Key Responsibilities:
The main activities will include observing surgical procedures in the operating room and providing education to sales teams on the various platforms of the manufacturer's surgical product line.
Lead Professional Education Programs for Health Care Providers and Internal Staff Members.
Provide activity & lead generation information into clients CRM system.
Collaboration with Marketing on Product, Procedure & Resource Expansion.
Educate the Field Sales Organization as needed.
Must be willing to travel a minimum of 50% - to attend surgical procedures.
Potential to represent client company at major conferences across the US.
Complete required administrative and other duties as assigned accurately and promptly.
Required Qualifications:
Education:
Must be a certified Physician Assistant (PA-C) required.
Minimum of 7 Years of PA-C Operating Room Experience within Urology, Ear, Nose, Throat (ENT) Plastics, ED, OB/GYN, Pediatrics specialties
Military experience will be considered.
The salary range for this role is $200,000 - $210,000. The actual salary will vary based on factors like candidate qualifications and competencies. In addition, this role is eligible for a 10% bonus paid quarterly on achieving set KPIs.
Benefits include healthcare, 401K, paid time off, and more.
Experience and Skills:
Required:
The Physician Assistant Clinical Specialist is expected to learn, know and follow all laws, regulations, policies and procedures related to the position and as stated in the policy and procedure manuals. The PACS will maintain the highest levels of professionalism, ethics and compliance at all times. Promptly communicate all legal/ethical questions or concerns to the supervisor or to the Health Care Compliance and/or Legal Department.
The ability to work in an operating room environment.
Strong interpersonal communication skills including the ability to communicate with a high level of technical acumen in a hospital type environment.
Qualified candidates must be self-motivated and have excellent relationship building skills.
Internal and external customer focus.
Ability to work independently and autonomously.
Ability to work in matrix and team structure.
A valid driver's license issued in the United States
Must successfully complete a background investigation, including a review of your driving record history.
The ability to travel as needed.
Residence in or willingness to relocate to the posted territory.
High level of attention to detail
#LI-CES
#LI-DNP
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at **********************
IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law. **********************/eoe
The potential base pay range for this role is 200,000-210,000 annually. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.
Auto-ApplyAssoc Director, R&D Quality
Parsippany-Troy Hills, NJ job
At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.
Every member of Gilead's team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we're looking for the next wave of passionate and ambitious people ready to make a direct impact.
We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.
Job Description
R&D Quality is seeking an Associate Director, Vendor Quality Management (VQM) to join our high-performing team that supports Clinical Development, Pharmacovigilance & Medical Affairs programs at Gilead. In this role you will be responsible for providing quality advice, direction, and leadership for quality and compliance oversight of GxP vendors. You will partner closely with business functions in applying a risk-based approach to key vendor activities which include vendor risk assessments, qualification/requalification and issue escalation.You will work closely with external quality groups to ensure vendor commitments & services meet Gilead standards and comply with regulations. You will act as the Quality Business Partner to assigned groups, such as Gilead R&D functions and vendors supporting Gilead R&D. You will provide expert advice on GxP risk minimization and mitigation. You will identify support management of vendor risks within the Development organization. You will participate in and/or lead Vendor Quality forums, Quality Management Review, Functional Quality forums and projects through providing quality metrics and analyzing quality data to identify risks and areas of focus.
The VQM group within R&D Quality needs someone with strong leadership skills, expert knowledge of the regulations governing drug development. This role will focus on vendor oversight activities, is highly visible, requires strong relationship building skills and the ability to influence and negotiate with cross-functional stakeholders. Professionalism and the ability to represent Gilead's reputation externally is critically important. An understanding of Quality Risk Management (QRM) principles, experience managing people, as well as a track record of leading complex, cross functional process improvement projects is desirable. You will be a part of an expert global Quality team that strives to be a trusted business partner and promotes a culture of Quality in all we do.
Primary Responsibilities:
Oversees comprehensive vendor quality oversight program which includes leading vendor risk assessments, Quality Issue Management for Pharmacovigilance and Medical Affairs vendors.
Interfaces with key internal business stakeholders and external groups including Vendors and Contract Research Organizations (CROs) Quality organizations.
Develops strong relationships with Gilead's key vendors, creating a mindset of partnership and mutual respect
Leads quality participation in vendor qualification, selection, requalification and quality management.
Lead and support development and ongoing management of Quality Agreements and Quality to Quality (Q2Q) meeting charters with key vendors
Leads Quality-to-Quality governance meetings and represents R&D Quality in Operational Management committee (OMC) meetings for key vendors.
Oversees effective vendor quality reporting to functional management and the Gilead Senior Leadership. This includes presenting relevant vendor quality metrics, trends and quality risks at quality meetings & governance forums
Reviews vendor contractual language from a quality & compliance perspective
Collaborates with the Audit team within R&D Quality on internal quality audits by providing risks and areas of focus for vendor audits,
Provides support for iregulatory inspections by functioning as the vendor liaison.
Supports management of significant quality deviations and CAPAs for vendor related activities.
Serves as an expert and provide guidance on and interpretation of GxP regulations, standards, and quality systems for internal stakeholders
Leads intra or interdepartmental teams as assigned, such as continuous improvement initiatives
Fosters a commitment to quality in individuals and a culture of quality across Gilead R&D and with R&D vendors.
Basic Qualifications:
10+ Years with BS/BA
OR
8+ Years with MS/MA or MBA
Preferred Qualifications:
Bachelor's degree with 12+ years; Masters degree with 10+ years of R&D Quality assurance compliance experience in a highly regulated environment.
Must have Clinical and pharmacovigilance audit and compliance experience
Proven experience in managing vendor quality programs and/or vendor relationship management for clinical development, Pharmacovigilance and medical affairs vendors
Has effectively operated within Clinical Quality Assurance or similar function in a Biopharma sponsor organization
Has experience advising business functions in the biopharma industry on quality and compliance
Strong relationship building skills, and ability to influence and negotiate with cross-functional stakeholders
Effective verbal, written, interpersonal skills to include delivering presentations to executives
Strong organizational & project management skills including the ability to prioritize and adapt to business needs while upholding compliance with regulations and company procedures.
Able to maintain a balance between being strategic and taking deeper tactical dives as needed
Excellent task and time management skills (e.g., project planning, prioritization)
Ability to travel up to 20% Preferred
Understanding of principles for Quality Risk Management (ICH Q9, ICH E6 R3)
Track record of successfully leading complex, large scale, time sensitive projects
Experience in developing KQIs and monitoring compliance and trends
Experience with Veeva Quality modules
About Gilead R&D Quality
Gilead R&D Quality is a phenomenal place to develop your skills and expertise. Our strong pipeline of therapies will provide you opportunities to be challenged and stretched while supported and developed by our diverse and expert team. We are a committed team of highly skilled Quality professionals dedicated to helping deliver life-saving therapies for unmet needs. We bring our passion for science, discovery, and creative thinking into everything we do. We are an inclusive and diverse community, who are supported by strong leaders that are committed to giving each of us a voice while achieving our mission. Our collaborative and supportive structure will help you develop your skills, experience, and your career.
People leader accountabilities
•Create inclusion - knowing the business value of diverse teams, modeling inclusion, and embedding the value of diversity in the way they manage their teams.
•Develop talent - understand the skills, experience, aspirations and potential of their employees and coach them on current performance and future potential. They ensure employees are receiving the feedback and insight needed to grow, develop and realize their purpose.
•Empower teams - connect the team to the organization by aligning goals, purpose, and organizational objectives, and holding them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem.
The salary range for this position is: $165,495.00 - $214,170.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*.
For additional benefits information, visit:
******************************************************************
* Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.
For jobs in the United States:
Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact ApplicantAccommodations@gilead.com for assistance.
For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster.
NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT
YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT
Gilead Sciences will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, (c) consistent with the legal duty to furnish information; or (d) otherwise protected by law.
Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.
Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.
For Current Gilead Employees and Contractors:
Please apply via the Internal Career Opportunities portal in Workday.
Auto-ApplyClinical Sales Specialist, Structural Heart, TAVI (New York City)
New York, NY job
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries.JOB DESCRIPTION:
Working at Abbott
At Abbott, you can do work that matters, grow, and learn, care for yourself and your family, be your true self, and live a full life. You'll also have access to:
Career development with an international company where you can grow the career you dream of.
Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
An excellent retirement savings plan with a high employer contribution
Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit - an affordable and convenient path to getting a bachelor's degree.
A company recognized as a great place to work in dozens of countries worldwide and named one of the most admired companies in the world by Fortune.
A company that is recognized as one of the best big companies to work for as well as the best place to work for diversity, working mothers, female executives, and scientists.
The Opportunity
Our business purpose is to restore health and improve quality of life through the design and provision of device and management solutions for the treatment of STRUCTURAL HEART disease. We aim to lead the markets we serve by requiring the solutions we offer customers to enable outcomes that advance the standard of care.
The job purpose and scope of the Clinical Sales Specialist (CSS) role is to provide TAVI clinical trial and commercial case support, trial enrollment & education initiatives for accounts within a defined region. In this role, the Clinical Sales Specialist will be an integrated part of the trial and commercial sales process in collaboration with the Territory Manager (TM) to educate interventional cardiologists, cardiac surgeons, and hybrid OR/cath lab personnel on the safe and effective use of Abbott TAVI products. The role is responsible for customer interface while demonstrating expertise with our TAVI clinical and commercial product portfolio, procedure & therapy to achieve best in class patient outcomes to advance clinical evidence and commercial market share.
This position may be hired at different level, depending on the experience of the candidate. This position may travel more than 50% depending on staffing and regional demands. The CSS will report to the Regional Sales Director with guidance from the Territory Manager on daily activities.
What You'll Work On
This position is responsible for the following TAVI clinical trial & commercial activities with key elements of technical & clinical expertise, training & education, customer service & communication skills. This position collaborates with the Territory Manager, Regional Sales Director, Clinical Lead Specialist to advance market share and optimize the customer clinical experience.
Successfully complete our internal training plan to include hemodynamics, ECG, angiography, echo & CT imaging modalities and complete the case support and proctor delegate authorizations.
Provide active clinical trial & commercial case support, demonstrating excellence in procedural success rates & patient outcomes.
Scrub in sterile and provide TAVI valve loading in procedures & training instruction to trial and commercial customers
Provide our customers CT valve sizing analysis utilizing the Pie Medical 3Mensio CT program
Provide trial site engagement & participation in subject selection committee calls
Lead customer didactic education sessions for account activation before first implants
Lead pre case planning & debriefing of heart team pre & post procedure and provide ongoing education as requested for proper in - service levels
Properly manage trial and commercial inventory & acquisition and field trunk stock
Provide documentation as required for quality assurance initiatives
Co-develop commercial business plan for assigned region with Territory Manager (TM)
Co-support internal/external quarterly business reviews with Territory Manager (TM)
Data entry into Salesforce, Mentor software for customer case support management
Learn commercial data analytics, resources & tools for effective customer experience
Support customer engagement strategy with Territory Manager (TM))
Demonstrate competency with marketing messaging, clinical evidence and medical education portfolio offering
Complete sales enablement training of professional selling skills and challenger methodology
Demonstrate knowledge in the TAVI market, industry & competitive insights
Participate in team meetings, conventions, and national sales meetings as requested
Complete vendor credentialing process for hospital access as required
Required Qualifications
Bachelor of Science (BS) or Arts (BA) college degree or equivalent clinical degree i.e., Registered Cardiovascular Invasive Specialist (RCIS), Certified Cardiology Technician, Registered nurse (RN) or Nurse Practitioner (NP), Transcatheter Cardiovascular Surgical/Scrub technician, Physician Assistant (PA).
9+ years clinical work experience required in hospital or medical device industry - 5+ years of which are in Structural Heart, endovascular/TEVAR/EVAR/TCAR specific clinical experience or has supported 300+ TAVI cases.
Verification that you will satisfy all vendor credentialing requirements, which may include vaccination for COVID-19. If you require a medical or religious accommodation from these requirements or if you would like to understand more about these requirements, please advise HR so that we can provide additional information and if needed, we can explore any needed accommodation(s).
Preferred Qualifications
Degree in life sciences
Strong consideration will be given to candidates with TAVI or transcatheter Structural Heart experience.
Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: **********************
Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.
Connect with us at *************** on Facebook at ************************ and on Twitter @AbbottNews.
The base pay for this position is
$75,300.00 - $150,700.00
In specific locations, the pay range may vary from the range posted.
JOB FAMILY:Sales Support & AdministrationDIVISION:SH Structural HeartLOCATION:United States of America : RemoteADDITIONAL LOCATIONS:WORK SHIFT:StandardTRAVEL:Yes, 50 % of the TimeMEDICAL SURVEILLANCE:YesSIGNIFICANT WORK ACTIVITIES:Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day), Driving a personal auto or company car or truck, or a powered piece of material handling equipment Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.EEO is the Law link - English: ************************************************************ EEO is the Law link - Espanol: ************************************************************
Auto-ApplyStrategy Consulting Associate (Summer 2026 Cohort)
Iqvia job in New York, NY
Please note that this is a hybrid position and will require regular presence at one of our offices in Boston, MA, New York, NY, or San Francisco, CA.
IQVIA Strategy Consulting is recognized as a global leader in serving the biopharmaceutical industry and is the management consulting arm of IQVIA, a leading provider of information, services and technology for the healthcare industry in 100+ countries.
Our teams offer deep expertise and unique methodologies to inform decisions about optimizing a treatment's potential, covering various aspects ranging from trial design to reimbursement submissions to life cycle management. We advise clients on a variety of business issues that include product portfolio strategy, commercial model design and optimization, pricing and market access strategy, therapy area and brand strategy, and launch strategy and planning.
Individuals joining IQVIA Strategy Consulting are assured a progressive and rewarding career with a clear path to advancement. You will have the opportunity to address complex and challenging client issues as an integral part of the project team. We operate in a truly multi-cultural, collegial, and collaborative work environment that fosters professional development and growth.
Responsibilities:
Contribute to internal brainstorming sessions to develop project methodology and recommendations
Conduct primary and secondary research to inform client solutions, leveraging IQVIA's proprietary tools and databases as necessary
Perform quantitative and qualitative analyses to inform strategic recommendations; exercise informed judgment in identifying the approach to addressing key business questions
Interview senior leaders and executives on the client team or external stakeholders (e.g. physicians, health insurers, thought leaders, and patients)
Contribute to the preparation, execution, and follow up of client workshops
Take ownership for the development of reports, presentations and other client deliverables, under the guidance of more senior team members
Present to client audiences via teleconference or in face-to-face meetings at the client site
Cultivate professional relationships with members of the client team
Acquire deep knowledge of IQVIA data sources and tools
Proactively develop knowledge of the healthcare industry and consulting methodologies
Assist in proposal development and thought leadership activities
Skills & Experience:
Proven analytical and problem-solving skills; critical thinking
Strong interpersonal and rapport building skills
Sound commercial awareness/business judgment and a keen interest in the life sciences
Demonstrated project management, time management and organizational skills
Attention to detail and ability to deliver high quality work within timeline
A self-starter who thrives in a client-focused, global team environment
Proficient in Microsoft Office (e.g. Word, PowerPoint, Excel)
Qualifications & Requirements:
A strong academic track record (GPA of 3.5/4.0 or greater preferred)
Bachelor's or Master's degree, (including but not limited to physical or life sciences, business, economics, engineering, statistics, applied mathematics, public health or relevant fields)
A solid track record of extra-curricular achievement and leadership
Excellent conversational and business English (written and oral); additional languages a plus
Knowledge of US and global health systems a plus
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at **********************
IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law. **********************/eoe
The potential base pay range for this role, when annualized, is $60,000.00 - $150,000.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.
Auto-ApplyFSP Senior Epidemiologist (Inflammation)
Iqvia Holdings Inc. job in New York, NY
* Design and conduct epidemiological studies to generate real-world evidence within time, budget, and quality standards, including but not limited to: natural history of disease, population characterization, assessment of treatment patterns and unmet need, development of external comparators, benchmarking of clinical outcomes, comparative safety and effectiveness research, and post-authorization studies
* Lead development of study protocols, analysis plans, and study reports to answer methodologic questions of priority to RWE
* Lead the identification of fit-for-purpose data for the timely execution of the RWE strategy
* Construct cohorts using RWD sources (e.g., claims, EHR) and evaluate key variables, including diagnosis and procedures codes, and plan validation studies as needed
* Conduct analyses for descriptive and comparative research using RWD for methodologic research questions
* Lead the communication of observational research results and methods, including development of pertinent sections of regulatory documents, reports, publications, white papers.
* Lead effective communication of study/analysis results to support internal and external decisions
* Coauthor abstracts and manuscripts for external dissemination of methodologic study results
* Demonstrated ability to manage stakeholders including external vendors and internal cross-functional teams
* The ideal candidate will bring strong epidemiologic methodologic expertise, a track record of designing innovative RWE studies, and the ability to translate complex data into actionable insights for internal and external stakeholders
Minimum Requirements:
* PhD in Epidemiology or related field with a minimum of four (4) years of relevant post-doctoral experience, preferably in pharmaceutical industry, biotechnology, or consulting environment. Master's degree in epidemiology or relevant scientific field, plus seven (7) years of experience in lieu of PhD may be acceptable.
* Understanding of observational research methods and experience to support the design and conduct of observational research, including protocol, statistical analysis plan, and study report development
* Extensive experience in both secondary database studies and primary data collection, including electronic medical record and/or medical claims databases
* Specifically, experience working with commercially available US datasets and data platforms
* Preferred experience in:
* Background in chronic autoimmune inflammatory conditions such as Rheumatoid arthritis, atopic dermatitis, lupus and asthma
* Experience in innovative study designs, such as synthetic control arms, external comparators, and hybrid RWD-clinical trial approaches, to support clinical development and regulatory decision-making
* A record of scientific publications demonstrating expertise in observational study design, analysis, and interpretation
* Demonstrated ability to function with an increasing level of autonomy and to develop productive cross-functional collaborations in a matrix environment
* Ability to manage priorities and performance targets
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at **********************
IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law. **********************/eoe
The potential base pay range for this role, when annualized, is $110,500.00 - $276,100.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.
Director, Project Management
Parsippany-Troy Hills, NJ job
At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.
Every member of Gilead's team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we're looking for the next wave of passionate and ambitious people ready to make a direct impact.
We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.
**Job Description**
Gilead's mission is to discover, develop, and deliver therapies that will improve the lives of patients with life-threatening illnesses worldwide.
**Job Responsibilities**
This role acts as both a functional and project manager in Product Launch & Change Planning (PLCP) within Global Clinical Supply Chain (GCSC), overseeing and allocating project managers to product launches, continuous improvement initiatives, and other projects. The position reports to the Sr. Director of Project Management.
**_Essential Duties and Job Functions:_**
+ Responsible for managing project managers to successfully launch new products into major markets.
+ Function as project manager for complex programs and key functional initiatives.
+ Act as an expert project manager for our PLCP function, collaborating with key stakeholders across Global Supply Chain (GSC) to develop strategies and proactively seek opportunities for continuous improvement projects.
+ Collaborate with Change Management to achieve sustainable continuous improvement outcomes.
+ Coach and mentor PLCP PMs to utilize project management best practices to efficiently manage assigned projects.
+ Identify, document, and share best practices to continuously improve project management skillset.
+ Ensure project work complies with established practices, policies and processes.
+ Leads PMs to solve complex operational problems or enhance processes.
+ Responsible for oversight and management of new product launch risks & issues.
+ Supports GSC resource management for project assignment and prioritization.
+ Track and maintains PLCP supported dashboards, trackers, and KPIs.
+ Ensure all key stakeholders are informed of PLCP activities through regular reporting and communications.
**Knowledge & Skills**
+ Knowledge of Six Sigma principles to analyze business processes and data to identify improvement opportunities.
+ Superior communication and listening skills with people at all levels of the organization.
+ Ability to promote an accountable and collaborative team-based environment.
+ Strategic thinker who can define vision and deliver results.
+ Strong and proven influencing, persuasion and negotiation skills.
+ Strong leadership skills to influence stakeholders and lead the PLCP team.
+ Proven ability to build and maintain strong collaborative relationships with executive leaders across the business.
**Education & Experience**
+ Twelve years of relevant experience with a Bachelor's degree required or Ten years of relevant expertise with a master's degree. Graduate degree preferred.
+ Experience in the biotech/pharmaceutical/medical device industry.
+ Proficiency with Smartsheet is required.
+ 12+ years of relevant working experience.
+ 7+ years of cross-functional project management experience across different development phases.
+ Strong communications skills.
+ Proven program/ project management skills.
+ Six Sigma experience and certification desired.
+ Operational acumen in a public company setting.
+ Experience managing multiple projects including partnerships with external partners.
+ Travel may be required - up to 10%.
**People Leader Accountabilities:**
-Create Inclusion - knowing the business value of diverse teams, modeling inclusion, and embedding the value of diversity in the
way they manage their teams.
-Develop Talent - understand the skills, experience, aspirations and potential of their employees and coach them on current
performance and future potential. They ensure employees are receiving the feedback and insight needed to grow, develop and
realize their purpose.
-Empower Teams - connect the team to the organization by aligning goals, purpose, and organizational objectives, and holding
them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem.
The salary range for this position is: $205,615.00 - $266,090.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*.
For additional benefits information, visit:
******************************************************************
* Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.
**For jobs in the United States:**
Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact ApplicantAccommodations@gilead.com for assistance.
For more information about equal employment opportunity protections, please view the 'Know Your Rights' (********************************************** poster.
NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT (*********************************************************
YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT
Gilead Sciences will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, (c) consistent with the legal duty to furnish information; or (d) otherwise protected by law.
Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.
Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.
**For Current Gilead Employees and Contractors:**
Please apply via the Internal Career Opportunities portal in Workday.
Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.
Clinical Trial Educator - Licensed Medical Professionals
Iqvia job in Parsippany-Troy Hills, NJ
The Clinical Trial Educator (CTE) will provide information and education on clinical trial inclusion and exclusion criteria to trial coordinators and healthcare providers. The Clinical Trial Educator will provide in-service presentations with the goal to increase patient enrollment. The CTE works in partnership with CRAs and other field-based medical teams for optimal trial execution, developing tailored recruitment plans. This position also requires the Clinical Trial Educator to work with referring physicians and develop referral networks to support the sites, as well as work with support groups in the therapeutic area. This is a full time, field-based position, up to 75% nationwide travel.
Qualifications/Experience:
Required:
+ Bachelor's degree (minimum)
+ Clinical research experience
+ Active license or credential in one of the following:
+ MD - Medical Doctor
+ DO - Doctor of Osteopathic Medicine
+ RN - Registered Nurse
+ NP - Nurse Practitioner
+ PA - Physician Assistant
+ Pharmacist - RPh or PharmD
+ Occupational Therapist
+ Physical Therapist
+ Respiratory Therapist
Preferred:
+ Certified Clinical Research Coordinator (CCRC)
+ 2+ years of experience as a Clinical Trial Educator or in healthcare education
+ Experience in community engagement and diversity in clinical trials
+ Business experience and customer service skills
+ Strong technology, administrative, and presentation skills
+ Excellent oral and written communication
+ Proven ability to conduct referral outreach, chart reviews, and data abstraction
+ Ability to work independently and coordinate across functions
+ Willingness to travel up to 75%, including overnight stays
Competencies:
- Demonstrated analytical skills
- Demonstrated Business Acumen
- Demonstrated success in persuasion, influence, and negotiation skills
- Demonstrated leadership ability
- Demonstrated ability to apply technical/scientific knowledge
- Flexibility to learn new products over time
- Knowledge of and experience with the selling process
- Initiative & execution-oriented
**IQVIA is an EEO Employer -** **Minorities/Females/Protected** **Veterans/Disabled**
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at **********************
IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law. **********************/eoe
The potential base pay range for this role, when annualized, is $62,300.00 - $195,100.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide.
To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us.
Senior Sales Representative, Agency Enablement
Iqvia Holdings Inc. job in New York, NY
IQVIA Digital powers exceptional brand experiences, delivering innovative solutions based on a customer-first, insights-driven, and integrated omnichannel vision. We provide authenticated, privacy-enhanced data and analytics, innovative fit-for-purpose healthcare technology, and the expertise to enable an effective and adaptable marketing model that drives better quality of care and patient outcomes. IQVIA is the leading global provider of data, advanced analytics, technology solutions and clinical research services for the life sciences industry.
As a Senior Sales Representative on our Agency Enablement team you will support the adoption of cutting-edge, privacy-optimized digital solutions across top agency holding companies and large independents. Based in NYC, this individual contributor will inherit a warm book of business and play a pivotal role in accelerating growth within the Healthcare & Life Sciences space by championing industry-leading, privacy-first digital solutions.
Job Overview
Develops new business for a specific product specialty, providing the product expertise and sales leadership to identify & qualify revenue opportunities, proactively manage the selling process, and close the sale in both existing and new accounts.
Essential Functions
* Achieves growth & revenue targets for assigned product through a consultative sales approach that solves client business issues.
* Proactively strengthens in-depth knowledge of product and its application within a client's enterprise.
* Participates with Account Directors to establish account planning strategy as it relates to assigned product area.
* Collaborates with Customer Team to target and validate opportunities for assigned customers / territory.
* Interfaces with customer at all levels.
* Creates and presents client proposals that result in winning sales.
* As necessary, identifies and manages resources to develop proposals that position IQVIA capabilities & solutions to customers.
* Monitors delivery, implementation, and customer satisfaction.
* Seeks "starburst" opportunities within existing customers to grow revenue opportunities across the IQVIA suite of offerings.
* As part of the sales process, gathers market and client intelligence and provides strategic feedback to Marketing, Consulting, Service, and Sales to strengthen offerings and capture additional business.
* May have leadership responsibility with less experienced solutions sales personnel.
* This role will require travel throughout New York City
Qualifications
* Bachelor's Degree Req
* Eight (8) years relevant sales or account management experience Req
* Possesses knowledge of key marketplace issues for the pharmaceutical industry and related businesses.
* Deep knowledge of one or more IQVIA specialty products along with subject matter expertise relating to client business processes that are improved by the IQVIA solution.
* Familiar with IQVIA offerings and account management.
* Must be a superior and successful sales person, have excellent presentation and writing skills, act with a sense of urgency, and be able to work both independently and within a team environment.
* Must have successful experience identifying and closing new business opportunities and developing positive relationships at all levels of client management and within IQVIA sales, consulting and marketing teams.
* Must be revenue driven, knowledgeable, consultative, a problem solver, customer focused, creative, resourceful, fast & flexible, team player, organized, and an effective negotiator.
#iqviadigital
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at **********************
IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law. **********************/eoe
The potential base pay range for this role, when annualized, is $107,900.00 - $200,300.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.
Clinical Research Associate, Sponsor Dedicated
Iqvia job in Parsippany-Troy Hills, NJ
, you must reside in the same country where the job is located. Whether you're beginning or continuing your career as a CRA, this role is an ideal stepping-stone. You'll have training and development to plan and progress your career in the direction you choose. And you won't do it alone - you will have dedicated mentoring and receive structured quarterly reviews on performance, promotion and bonus awards.
Award winning and innovative, we'll give you access to cutting-edge in-house technology, allowing you to work on global projects but with a regional / home state travel remit, so no need for national travel in certain countries. You'll be building a smart and flexible career with no limits.
**While projects vary, your typical responsibilities might include:**
+ Performing site selection, initiation, monitoring and close-out visits, plus maintaining appropriate documentation
+ Supporting the development of a subject recruitment plan
+ Establishing regular lines of communication plus administering protocol and related study training to assigned sites
+ Evaluating the quality and integrity of site practices - escalating quality issues as appropriate
+ Managing progress by tracking regulatory submissions, recruitment, case report form (CRF) completion, and data query resolution
You will need to be comfortable collaborating and communicating with a variety of colleagues and customers. Ideally, you will also have a good basic knowledge of applicable clinical research regulatory requirements.
You should have:
+ A Bachelor's degree in a health care or other scientific discipline or educational equivalent
+ Successful completion of a CRA Trainee Program or at least three months of on-site monitoring experience. 2 years of clinical research coordinator experience strongly preferred.
+ Alternatively, you should have an equivalent combination of education, training and experience
If you want to make an impact in the global research market, where we are working to make a real difference in patient health, we ask you to apply now and join our team.
\#CRASDAJD
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at **********************
IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law. **********************/eoe
The potential base pay range for this role, when annualized, is $64,000.00 - $189,000.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide.
To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us.
EEO Minorities/Females/Protected Veterans/Disabled
Associate Director, Liver (PBC) Franchise Marketing - Regional Engagement Lead (East)
Parsippany-Troy Hills, NJ job
At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.
Every member of Gilead's team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we're looking for the next wave of passionate and ambitious people ready to make a direct impact.
We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.
**Job Description**
The Associate Director (AD), Liver Franchise Marketing - Regional Engagement, Insights and Events will report directly to the Senior Director, US Liver Franchise Opinion Leader Programming. This role will have an impact across the Liver franchise, with a focus on Primary Biliary Cholangitis (PBC). The successful candidate will be a strategic thinker who is able to uphold high execution standards for the Opinion Leader Programming team. They must be able to exercise strong leadership skills, uphold a compliance mindset and collaborate with a diverse set of internal stakeholders and external opinion leaders. The AD will be responsible for the essential duties and job functions listed below. This is a field-based role in the East Region with the preferred candidate being in New Jersey, New York or Pennsylvania.
**Essential Duties and Job Functions**
+ Support the development and execution of the PBC Marketing strategic plan focusing on the regional engagement initiatives, insight gathering and events management.
+ Work to pull through Liver Franchise strategic priorities with key stakeholders ensuring coordination across Marketing & Sales teams, as well as cross functionally.
+ Drive the development and implementation of key regional priority opportunities and activations.
+ Foster Gilead's Liver leadership narrative while amplifying key partnership activities.
+ Develop and execute insight plan for key stakeholders, inclusive of speaker bureau and regional advisory boards when appropriate
+ Orchestrate Gilead's presence at key Liver events and sponsorships ensuring engagement across the organization and alignment with our commercial strategic priorities
+ Manages and direct agency partners to deliver on the annual tactical plan within the assigned budget.
+ Develop and deliver presentations to a range of internal stakeholders and external audiences
+ Ensure compliance with all relevant laws, regulations and policies
**Basic Qualifications:**
Bachelor's Degree and Ten Years' Experience
OR
Masters' Degree and Eight Years' Experience
OR
PhD and Two Years' Experience
**Preferred Qualifications**
+ 10 years of professional experience,
+ 8+yrs MS/MA or MBA
+ Bachelor's degree in marketing or related fields required.
+ Familiarity with marketing fundamentals, strategy, sales and commercial policies and practices.
+ Previous experience in marketing research and/or pharmaceutical sales desired.
+ MBA or other advanced business or public health degree is desired.
+ Liver experience and relationships is preferred
+ Strong customer focus
+ Adept at forming and maintaining a collaborative work environment
+ Strong interpersonal, verbal communication, and writing skills, including the ability to simplify complex topics
+ Listens carefully to others' points of view, adapts style and content based on audience, and seeks to understand others' motivations and needs
+ Demonstrated excellence in project management, effectively managing multiple projects/priorities
+ This role will require up to 75% travel
**People Leader Accountabilities**
+ Create Inclusion - knowing the business value of diverse teams, modeling inclusion, and embedding the value of diversity in the way they manage their teams.
+ Develop Talent - understand the skills, experience, aspirations, and potential of their employees and coach them on current performance and future potential. They ensure employees are receiving the feedback and insight needed to grow, develop, and realize their purpose.
+ Empower Teams - connect the team to the organization by aligning goals, purpose, and organizational objectives and holding them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem.
The salary range for this position is: $177,905.00 - $230,230.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*.
For additional benefits information, visit:
******************************************************************
* Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.
**For jobs in the United States:**
Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact ApplicantAccommodations@gilead.com for assistance.
For more information about equal employment opportunity protections, please view the 'Know Your Rights' (********************************************** poster.
NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT (*********************************************************
YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT
Gilead Sciences will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, (c) consistent with the legal duty to furnish information; or (d) otherwise protected by law.
Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.
Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.
**For Current Gilead Employees and Contractors:**
Please apply via the Internal Career Opportunities portal in Workday.
Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.