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United Therapeutics jobs in Durham, NC

- 81 jobs
  • Warehouse Supervisor (Materials Management)

    United Therapeutics Corporation 4.8company rating

    United Therapeutics Corporation job in Raleigh, NC

    California, US residents click here. The job details are as follows: Who We Are We are the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit corporation. Our public benefit purpose is to provide a brighter future for patients through the development of novel pharmaceutical therapies; and technologies that expand the availability of transplantable organs. United Therapeutics (Nasdaq: UTHR) seeks to travel down the corridors of indifference to develop treatments for rare, deadly diseases. We were founded in 1996 by a family seeking a cure for their daughter's pulmonary arterial hypertension( PAH). Today, we have six FDA-approved therapies that treat PAH, pulmonary hypertension associated with interstitial lung disease (PH-ILD) and neuroblastoma, a rare pediatric cancer. Our near-term pipeline seeks to develop additional therapies for PAH and pulmonary fibrosis (PF). The cure for end-stage life-threatening diseases like PAH, PH-ILD, PF, and many others is an organ transplant, but only a small percentage of donated organs are available to address the vast need. For this reason, we are working to create bio-artificial organs to address the shortage of kidneys, hearts, lungs, and livers available for transplant. We believe an unlimited supply of tolerable, transplantable organs will eliminate the transplant waiting list and cure end-stage organ diseases for which transplant is not currently an option. Who You Are You are a natural leader who thrives on building structure from the ground up. You're passionate about creating efficient processes, mentoring a team, and driving operational excellence in a fast-paced, highly regulated environment. You take pride in ensuring accuracy, compliance, and quality at every step-from receiving GMP materials to shipping finished products. With a keen eye for improvement and a hands-on approach, you're ready to implement innovative solutions, lead automation projects, and set the standard for a world-class warehouse operation. If you're energized by the challenge of shaping something new and making a lasting impact, this is your opportunity to lead and grow. The Warehouse Supervisor, Dry Powder Inhalation (DPI) is responsible for overseeing incoming GMP material receipts, expensed supplies and material receipts, control and issuance of materials, and final preparation of product shipments. This role is also responsible for personally training, mentoring, and leading warehouse operations staff in supporting a cGMP warehouse operation in accordance with UT policies and procedures. A key responsibility of this role is to guarantee that their team adheres to UT corporate policies and procedures, with focus on proper non-exempt time management. Ensure warehouse team is completing daily tasks in a timely manner and in compliance with UT standards while looking for ways to improve these processes. Lead in the development and implementation of updated warehouse automation projects. * Oversee warehouse team in the prioritization of warehouse tasks and activities for completion of inbound material processing and outbound product shipment requirements * Direct and manage direct reports to include responsibilities for training, goal setting & achievement, performance evaluations/management, coaching, mentoring, career development and provide support for recruitment process (as needed) * Oversee the receiving process of GMP and expensed materials according to SOPs * Supervise outbound product shipments in support of the distribution schedule, including but not limited to booking carriers, preparing bills of lading, and obtaining receipt confirmations * Enter and oversee warehouse material control transactions in SAP * Track GMP and expensed material stock levels * Perform as well as oversee disposal of hazardous, non-hazardous, and general waste materials according to SOPs * Ensure that the warehouse and all material storage areas are maintained in a clean and orderly fashion * Oversee inventory and ensure shipping supplies are ordered to meet distribution requirements * Coordinate with Quality Assurance department to ensure that materials are tested and released in a timely manner * Oversee and ensure GMP materials are staged according to pick list requirements for production and packaging operations * Assist in the completion of year end physical inventory count * Coordinate with EHS to repot any potential safety issues * Ensure that non-inventoried ancillary supplies are always on hand and that we are sourcing these items from the best vendors for our needs * Coordinate the material flow between multiple RTP warehouses * All other duties as assigned Minimum Requirements * H.S. Diploma or General Education Degree (GED) * 9+ years of warehouse experience in a regulated manufacturing environment with a H.S. Diploma/GED OR 7+ years of warehouse experience in a regulated manufacturing environment with an Associate Degree * Knowledge and understanding of cGMPs for warehouse operations, manufacturing, and material control * Previous experience with operation of mechanical warehouse equipment * Previous experience with SAP/ERP systems * Training and experience with the handling and storage of hazardous materials * Ability to execute a work plan and adapt to schedule changes * Good organizational skills * Ability to train and mentor teammates in processing GMP material control tasks for inbound and outbound requirements * Ability to communicate effectively with other departments within the company Preferred Qualifications * Associate Degree * Ability to author and edit warehouse SOP's Job Location United Therapeutics requires this candidate to be on-site at our Durham, North Carolina location 100% of the time. Physical Demands This position will require frequent standing and walking, as well as pushing and pulling up to 300 pounds. There may be occasional lifting and carrying up to 50 pounds of weight. At United Therapeutics, our mission and vision are one. We use our enthusiasm, creativity, and persistence to innovate for the unmet medical needs of our patients and to benefit our other stakeholders. We are bold and unconventional. We have fun, we do good. Eligible employees may participate in the Company's comprehensive benefits suite of programs, including medical / dental / vision / prescription coverage, employee wellness resources, savings plans (401k and ESPP), paid time off & paid parental leave benefits, disability benefits, and more. For additional information on Company benefits, please visit ****************************************************** United Therapeutics Corporation is an Equal Opportunity Employer, including veterans and individuals with disabilities.
    $43k-56k yearly est. Auto-Apply 6d ago
  • Pharmaceutical Packaging Technician I

    United Therapeutics Corporation 4.8company rating

    United Therapeutics Corporation job in Raleigh, NC

    California, US residents click here. The job details are as follows: Who we are We are the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit corporation. Our public benefit purpose is to provide a brighter future for patients through the development of novel pharmaceutical therapies; and technologies that expand the availability of transplantable organs. United Therapeutics (Nasdaq: UTHR) seeks to travel down the corridors of indifference to develop treatments for rare, deadly diseases. We were founded in 1996 by a family seeking a cure for their daughter's pulmonary arterial hypertension (PAH). Today, we have six FDA-approved therapies that treat PAH, pulmonary hypertension associated with interstitial lung disease (PH-ILD) and neuroblastoma, a rare pediatric cancer. Our near-term pipeline seeks to develop additional therapies for PAH and pulmonary fibrosis (PF). The cure for end-stage life-threatening diseases like PAH, PH-ILD, PF, and many others is an organ transplant, but only a small percentage of donated organs are available to address the vast need. For this reason, we are working to create manufactured organs to address the shortage of kidneys, hearts, lungs, and livers available for transplant. We believe an unlimited supply of tolerable, transplantable organs will eliminate the transplant waiting list and cure end-stage organ diseases for which transplant is not currently an option. Who you are We are seeking a detail-oriented Pharmaceutical Packaging Technician I to join our team at the RTP facility. In this role, you will be responsible for setting up, operating, and cleaning pharmaceutical packaging equipment, including bottle lines, blister lines, cartoning lines, and manual kitting operations. Under direct supervision, you will support packaging and kitting operations, perform in-process checks, equipment adjustments, yield calculations, and batch reconciliations-ensuring strict adherence to company SOPs, MBRs, cGMPs, and safety regulations. If you have a keen eye for accuracy, a commitment to compliance, and a passion for pharmaceutical packaging, we'd love to hear from you! For this role you will need Minimum Requirements * H.S. Diploma or General Education Degree (GED) * Basic computer skills Preferred Qualifications * Associates Degree * 1+ years of hands-on experience in a pharmaceutical manufacturing, packaging or warehouse environment (will consider commensurate experience and/or combination of education and experience) * Ability to navigate sophisticated HMI control systems on automated pharmaceutical packaging equipment * Experience with GMP documentation requirements and have experience with completing batch packaging records, reading and understanding SOPs, and working with packaging machinery Job Location United Therapeutics requires this candidate to be on-site at our Durham, North Carolina location 100% of the time. At United Therapeutics, our mission and vision are one. We use our enthusiasm, creativity, and persistence to innovate for the unmet medical needs of our patients and to benefit our other stakeholders. We are bold and unconventional. We have fun, we do good. Eligible employees may participate in the Company's comprehensive benefits suite of programs, including medical / dental / vision / prescription coverage, employee wellness resources, savings plans (401k and ESPP), paid time off & paid parental leave benefits, disability benefits, and more. For additional information on Company benefits, please visit ****************************************************** United Therapeutics Corporation is an Equal Opportunity Employer, including veterans and individuals with disabilities.
    $33k-41k yearly est. Auto-Apply 12d ago
  • Intern - Human Resources - HR Shared Services

    Gilead Sciences 4.5company rating

    Raleigh, NC 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 As a Gilead intern you will contribute to high-impact meaningful projects that will not only further advance our company's mission but will allow you to gain real world experience at one of the most innovative organizations in the world. You will also have opportunities to participate in special events including professional development and leadership presentations, social/network building activities and local community volunteer programs. Key Responsibilities will include, but are not limited to the following: Perform all assigned tasks accurately, efficiently and in accordance with applicable policies and procedures Work closely with members of assigned team to develop subject matter knowledge Attend company/department/team trainings and meetings as appropriate Maintain accurate and updated employee records in accordance with company policies and government regulations Provide answers to employee questions and problem-solves as needed Assist in the development and improvement of HR processes and procedures Compose competent employee communications regarding HR information and process changes Prepare HR-related reports and surveys Showcase your work with a final presentation (PPT) near the conclusion of your internship Required Qualifications: Must be at least 18 years old Must have a minimum GPA of 2.8 Authorized to work in the United States without Sponsorship now or in the future or CPT/OPT through your University. Must be currently enrolled as a full-time student in a Bachelor's/Masters/MBA/PhD program at an accredited US based university or college Must be a Rising Sophomore, Junior, or Senior in undergrad or a Graduate or Doctoral Student Must be enrolled full-time in the Fall Semester at an accredited university/college after the completion of the internship Must be able to complete a 10-12 consecutive week internship between May and August Must be able to relocate if necessary and work at the designated site for the duration of the internship Preferred Qualifications: Preferred Degree qualification: master's or undergraduate in fields of mathematics or business administration Proficiency with MS Office Suite Ability to identify issues and seek solutions Ability to work both independently and collaboratively Demonstrated commitment to inclusion and diversity in the workplace Efficient, organized, and able to handle short timelines in a fast-paced environment Good analytical skills with attention to detail Ability to maintain high standards of confidentiality Show strong passion for building a career in Human Resources Workday or ServiceNow knowledge a plus but not required Gilead Core Values: Integrity (Doing What's Right) Inclusion (Encouraging Diversity) Teamwork (Working Together) Excellence (Being Your Best) Accountability (Taking Personal Responsibility) The expected hourly range for this position is $19.00 - $55.00. Gilead considers a variety of factors when determining base compensation, including education level and geographic location. These considerations mean actual compensation will vary. Benefits include paid company holidays, sick time, and housing stipends for eligible employees. 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.
    $19-55 hourly Auto-Apply 25d ago
  • Scientist - Matrix Biology

    United Therapeutics Corporation 4.8company rating

    United Therapeutics Corporation job in Raleigh, NC

    California, US residents click here. The job details are as follows: Who We Are We are the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit corporation. Our public benefit purpose is to provide a brighter future for patients through the development of novel pharmaceutical therapies; and technologies that expand the availability of transplantable organs. United Therapeutics (Nasdaq: UTHR) seeks to travel down the corridors of indifference to develop treatments for rare, deadly diseases. We were founded in 1996 by a family seeking a cure for their daughter's pulmonary arterial hypertension (PAH). Today, we have six FDA-approved therapies that treat PAH, pulmonary hypertension associated with interstitial lung disease (PH-ILD) and neuroblastoma, a rare pediatric cancer. Our near-term pipeline seeks to develop additional therapies for PAH and pulmonary fibrosis (PF). The cure for end-stage life-threatening diseases like PAH, PH-ILD, PF, and many others is an organ transplant, but only a small percentage of donated organs are available to address the vast need. For this reason, we are working to create manufactured organs to address the shortage of kidneys, hearts, lungs, and livers available for transplant. We believe an unlimited supply of tolerable, transplantable organs will eliminate the transplant waiting list and cure end-stage organ diseases for which transplant is not currently an option. How you'll contribute We are looking for our missing puzzle piece, an extracellular matrix (ECM) enthusiast who is looking to apply that expertise to a scale with impact that could change the world? This position will advance progress towards the generation of a functional engineered lung, with a specific focus on the role of the lung scaffold during cellular repopulation, including cell-matrix interactions, matrix changes during culture, and the impact of matrix properties on cellular repopulation. Interested? We can't wait to meet you - let's chat soon! * Characterize the stability of matrix components, identify relevant degradation profiles, and mitigate degradation of key components, as appropriate * Identify potential process changes or storage conditions to mitigate stability concerns, and contribute to the evaluation and implementation of changes to process or storage conditions * Analyze recellularization outcomes to understand the role of the ECM scaffold in the biology of regeneration in engineered lung constructs * Evaluate and optimize scaffold ECM stability from decellularization through recellularization and terminal pulmonary function assessments * Determine the proper chemical conditions for ECM stability, ECM component supplementation and adsorption, and ECM-cell interactions * Analyze matrix composition, turnover, and cell-derived matrix deposition in engineered tissues, interpret these findings, and provide insightful and actionable methods to improve or stabilize the function of the engineered tissues which may include supplementation with bioactive matrix or matrix-associated molecules * Assess the mechanical function of the scaffold at the organ (pulmonary mechanics) and tissue (interstitial, alveolar, and microvascular integrity) levels and develop methods to promote the proper organization and function of the matrix molecules to achieve optimal regeneration of native organ function * Evaluate the consistency of findings between in vitro assays and large-scale recellularization studies, adjusting or developing new assays as necessary * Independently integrate analyses from experiments across multiple sub-teams to determine key factors which drive outcomes, as needed * Develop new techniques, laboratory procedures, and/or protocols to support lung scaffold recellularization and characterization efforts, as needed * Proficiently perform complex scientific tasks and independently make complex technical or scientific decisions * Proficiently analyze data, potentially utilizing sophisticated or in-depth analyses, and through such analyses, identify novel data trends * Evaluate new technologies or methods, applying scientific insights to the process. Coordinate tech transfer with academic & industrial collaborators. * Develop and implement novel, impactful, and/or complex experimental plans. Generate insightful complex hypotheses and conclusions. Apply scientific knowledge and literature evidence to experimental planning. * Prepare and present regular reports on research strategy and progress * Independently contribute to focused research areas through maintenance and continued development of knowledge using past and current scientific literature as well as collaborative thinking * Commit to supporting individual, group, and departmental goals to achieve key objectives * Appropriately document performance and methods * Help maintain smooth operations of the lab, including maintaining lab supplies, monitoring equipment and providing lab support * Perform other duties as assigned For this role you will need Minimum Requirements * Masters degree with 6+ years of related industry or academic faculty-level experience or a PhD with 2+ years of related industry or academic faculty-level experience * 5+ years of experience and comfort developing, optimizing ,and performing analytical assays, evaluating and interpreting data, and optimizing and troubleshooting analytical assays * Experience includes proficiency with at least 4 of the following analytical tools in support of research efforts: histology, immunohistochemistry, image analysis, SEM/TEM, biochemistry, ELISA, Western Blot, and/or proteomics/glycomics, mechanical testing * Experience with statistical analysis utilizing JMP, GraphPad Prism, R or other comparable program * Proficiency and experience developing, optimizing ,and performing analytical assays, evaluating and interpreting data, and optimizing and troubleshooting analytical assays * Proficient in applying Design of Experiments (DOE) principles and advanced statistical methods for experimental planning and data interpretation * Familiarity with material and device biocompatibility evaluation and associated regulatory requirements Preferred Qualifications * Doctor of Philosophy (PhD) in protein/cell biology, biomaterials, biotechnology, biomedical engineering, biomechanics, or related field * Performs and interprets results of uniaxial mechanical testing * Experience with MatLab and/or Python * Comparative Proteomic Quantitation/Comparative Analysis Program(s) * Previous regenerative medicine or tissue engineering experience involving cellular and matrix or scaffold interactions * Experience/knowledge in one or more of the following: - Mechanical characterization of biomaterials, Chemical modifications of extracellular matrix, - Immunological techniques (IHC, ELISA), - Accelerated degradation study of biomaterials, product or prototype characterization of proteins, and/or - Protein detection, western blot or ELISA especially as applied to ECM component or degradative products * Contribution to regulatory filing(s) in support of clinical candidate development Eligible employees may participate in the Company's comprehensive benefits suite of programs, including medical / dental / vision / prescription coverage, employee wellness resources, savings plans (401k and ESPP), paid time off & paid parental leave benefits, disability benefits, and more. For additional information on Company benefits, please visit ****************************************************** United Therapeutics Corporation is an Equal Opportunity Employer, including veterans and individuals with disabilities.
    $59k-93k yearly est. Auto-Apply 29d ago
  • Patient Navigator, Patient Support Operations

    United Therapeutics Corporation 4.8company rating

    United Therapeutics Corporation job in Morrisville, NC

    California, US residents click here. The job details are as follows: Who we are We are the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit corporation. Our public benefit purpose is to provide a brighter future for patients through the development of novel pharmaceutical therapies; and technologies that expand the availability of transplantable organs. United Therapeutics (Nasdaq: UTHR) seeks to travel down the corridors of indifference to develop treatments for rare, deadly diseases. We were founded in 1996 by a family seeking a cure for their daughter's pulmonary arterial hypertension (PAH). Today, we have six FDA-approved therapies that treat PAH, pulmonary hypertension associated with interstitial lung disease (PH-ILD) and neuroblastoma, a rare pediatric cancer. Our near-term pipeline seeks to develop additional therapies for PAH and pulmonary fibrosis (PF). The cure for end-stage life-threatening diseases like PAH, PH-ILD, PF, and many others is an organ transplant, but only a small percentage of donated organs are available to address the vast need. For this reason, we are working to create manufactured organs to address the shortage of kidneys, hearts, lungs, and livers available for transplant. We believe an unlimited supply of tolerable, transplantable organs will eliminate the transplant waiting list and cure end-stage organ diseases for which transplant is not currently an option. Who you are You are someone who believes in delivering "best in class" customer service. You are a calm and patient listener and love to research issues and find compliant and helpful solutions. You are excited to work for a company that is passionate, inspiring and always patient-centric. The Patient Navigator, Patient Support Operations, plays a pivotal role in educating customers about our PAH and PH-ILD products, while also providing essential services that streamline patient access to therapy. Compliantly adhering to FDA and other regulatory guidelines, the Patient Navigator takes ownership of the patient journey, expertly guiding individuals through the complexities of obtaining prescribed medication. By acting as a bridge between patients, caregivers, and healthcare providers (HCPs), this role effectively eliminates non-clinical barriers to therapy. The Patient Navigator has a strong sense of ownership, adept problem-solving abilities, and provides compassionate, patient-centered care from case initiation to closure. Moreover, the Patient Navigator uses exceptional interpersonal skills to provide support and education to patients regarding their disease state, understanding of medical and pharmacy benefits, as well as thorough product education and service explanations. The objective of our overall Patient Support Program is to ensure patients have the knowledge, resources, and logistical support necessary to help effectively manage their conditions and adhere to treatments as prescribed by their HCP. This role will contribute to our overall Patient Support vision by: Providing a "Best in Class" customer experience for our patients, prescribers and caregivers Removing non-clinical barriers to therapy Operating in compliance with FDA and Standard Operating Procedures Supporting a culture that ignites passion. Minimum Requirements Associates Degree in life sciences, business, or a related field with 4+ years of relevant experience in case management, customer service, or patient experience management or, Bachelor's Degree with 2+ years of relevant experience in case management, customer service, or patient experience management. Strong sense of ownership, adept problem-solving abilities, exceptional interpersonal skills and ability to offer compassionate, patient-centered care, support and education Professional telephone etiquette; effective verbal and written communication skills Strong communication and interpersonal skills, with the ability to effectively engage on the phone or in person with patients, healthcare professionals, and cross-functional teams Empathy, compassion, and a patient-centric mindset to provide the “best in class” customer service Adaptive, anticipating the needs of the business and patients, while being open to feedback. Ability leading without authority, possessing a drive for results Excellent problem solving, time management and organization skills Candidate must be able to work onsite M-F from 10:00 a.m. - 7:00 p.m. ET Preferred Qualifications Bachelor's Degree in life sciences, business, or a related field Strong proficiency with Microsoft Office suite Experience working in an SOP environment Prior case management ownership of a territory Experience utilizing CRM (e.g. Health cloud, Salesforce) to carry out patient support related activities Experience working with patient support programs, case management, and adherence program designs Rare disease and / or complex therapy administration experience Experience with text or chat HIPAA compliant communication methods Bilingual Spanish Job Location This position will be located at our Morrisville, NC office. Currently this job is a fully onsite role. At United Therapeutics, our mission and vision are one. We use our enthusiasm, creativity, and persistence to innovate for the unmet medical needs of our patients and to benefit our other stakeholders. We are bold and unconventional. We have fun, we do good. Learn more about United Therapeutics Cares: ************************************ Eligible employees may participate in the Company's comprehensive benefits suite of programs, including medical / dental / vision / prescription coverage, employee wellness resources, savings plans (401k and ESPP), paid time off & paid parental leave benefits, disability benefits, and more. For additional information on Company benefits, please visit ****************************************************** United Therapeutics Corporation is an Equal Opportunity Employer, including veterans and individuals with disabilities.
    $35k-44k yearly est. Auto-Apply 3d ago
  • Intern - IT - Enterprise Data & Analytics

    Gilead Sciences 4.5company rating

    Raleigh, NC 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 As a Gilead intern you will contribute to high-impact meaningful projects that will not only further advance our company's mission but will allow you to gain real world experience at one of the most innovative organizations in the world. You will also have opportunities to participate in special events including professional development and leadership presentations, social/network building activities and local community volunteer programs. Key Responsibilities will include, but are not limited to the following: Learning Objectives: US Commercial Data, AWS and Databricks data pipelines, Gilead culture Data & Analytics DevOps: Assist the team in adhoc DevOps manager tasks GenAI: Lead Innovation POCs with GenAI-first approach to improve team operations and end-user experience Strategy & Roadmap: Influence cross-functional partners like the Platform team to streamline team's technical Roadmap intake and monitor its execution Team support: Assist the team in broader communication activities like newsletters, QBRs and team events organization Showcase your work with a final presentation (PPT) near the conclusion of your internship Required Qualifications: Must be at least 18 years old Must have a minimum GPA of 2.8 Authorized to work in the United States without Sponsorship now or in the future or CPT/OPT through your University. Must be currently enrolled as a full-time student in a Bachelor's/Masters/MBA/PhD program at an accredited US based university or college Must be a Rising Sophomore, Junior, or Senior in undergrad or a Graduate or Doctoral Student Must be enrolled full-time in the Fall Semester at an accredited university/college after the completion of the internship Must be able to complete a 10-12 consecutive week internship between May and August Must be able to relocate if necessary and work at the designated site for the duration of the internship Preferred Qualifications: Preferred Degree qualification: BA/BS Proficiency with MS Office Suite Ability to identify issues and seek solutions Ability to work both independently and collaboratively Demonstrated commitment to inclusion and diversity in the workplace Efficient, organized, and able to handle short timelines in a fast-paced environment Gilead Core Values: Integrity (Doing What's Right) Inclusion (Encouraging Diversity) Teamwork (Working Together) Excellence (Being Your Best) Accountability (Taking Personal Responsibility) The expected hourly range for this position is $19.00 - $55.00. Gilead considers a variety of factors when determining base compensation, including education level and geographic location. These considerations mean actual compensation will vary. Benefits include paid company holidays, sick time, and housing stipends for eligible employees. 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.
    $36k-46k yearly est. Auto-Apply 33d ago
  • Associate Director, Clinical Data Science Compliance Oversight

    Gilead Sciences, Inc. 4.5company rating

    Raleigh, NC 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: * Lead in the development and implementation of quality strategy and associated capabilities to support the CDS objectives * Manage quality review of clinical trial documents, workflows, and outputs within the CDS organization to ensure clinical trials are conducted in compliance with Gilead procedures, GCP and applicable global regulations * Analyze trends to identify process gaps, improvement opportunities and areas requiring corrective/preventive actions * Lead new quality focused initiatives focused on new learnings, findings, and observations to continuously improve CDS quality practices and methods * Work closely with Gilead CDS study team to provide expert advice on compliance issues and risk mitigation actions * Collaborate with the audit, inspection and CAPA management team within Gilead R&D Quality on internal audits, regulatory agency inspections, risk assessment, deviations and CAPA activities * Liaison and coordinate with business experts and stakeholders to support resolution of audit outcomes which require further action or response. Partner closely with business units to lead, track and manage corrective actions or risk mitigation activities * Serve as a Change Champion for Gilead QMS-related communications to the CDS organization consolidating and channeling just-in-time information and resources to prepare the organization for change * Analyze new regulations and polices with emphasis Good Clinical Practices (GCP) and partner with business experts and stakeholders to update internal documentation and practices accordingly based on areas of impact * Foster a commitment to quality in individuals and a culture of quality across the CDS organization and with CDS related service providers 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 relevant experience with a BS degree in life sciences or related field with significant experience advising business functions in the biopharma industry on quality and compliance requirements, evolving regulations, risk minimization and mitigation, and vendor management * 8 years of relevant experience with a Master's degree in life sciences or related field with significant experience advising business functions in the biopharma industry on quality and compliance requirements, evolving regulations, risk minimization and mitigation, and vendor management * Experience working across a broad spectrum of quality and compliance activities, including authoring and reviewing SOPs, facilitating internal audits, supporting regulatory inspections, developing and managing CAPAs and deviations, and training others on quality and compliance requirements * Significant experience participating in cross-functional projects and teams with responsibilities related to clinical trials or other drug development activities * Familiar with the practice of recording and monitoring quality observations through a Quality Management System (QMS) Knowledge & Other Requirements: * In-depth knowledge of regulatory requirements applicable to the conduct of clinical trials and guidelines (e.g., FDA, EMA, ICH) and related industry standards and trends * Through knowledge of the drug development process, including all key functions involved in the various stages of drug development from early research through post-marketing * Strong analytical skills to assess quality issues and lead the resolution in a collaborative manner across functions * Significant experience advising business function and senior leadership team on quality & compliance requirements, evolving regulation, risk mitigation, and continuous improvement * Strong track record of cultivating and maintaining strategic relationships and collaboration both internally and externally 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: Bay Area: $182,070.00 - $235,620.00. Raleigh: - . 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.
    $182.1k-235.6k yearly Auto-Apply 45d ago
  • Senior Specialist, Marketing

    Merck 4.6company rating

    Raleigh, NC job

    **Reporting to the CFA Strategy and Operations Lead, the Customer Facing Application (CFA) Strategy and Operations Senior Specialist executes the strategic roadmap for US Commercial customer-facing applications, including the evolution of Veeva and Veeva Account Management.** **Through a deep understanding of customer-facing roles, including that of the Field Sales Representative and Key Account Manager, this individual will partner closely with internal stakeholders across business and technical teams, as well as external providers to evolve our strategic customer engagement model. The CFA senior specialist will directly contribute to the transformation to a bi-directional engagement model through our Veeva capabilities and processes for field representatives.** **The individual will condense the desired changes or strategic platform enhancement requests into consumable artifacts for distribution/sharing with impacted stakeholders to address both long and short-term issues facing field sales. The individual will represent the field facing channel to drive an omnichannel experience with our customers. The individual will triage and address operational issues that arise related to capability modifications. These capabilities align to key field sales competencies, namely, customer activity reporting, product promotion and business acumen.** **Success in this role will require strong project management skills and an effective partnership across many functions including Sales Leadership, Account Executive Leadership, US Market Operations, Technical, Training, Compliance and Communications teams.** **This role will ensure:** **Realization of the US Commercial CFA roadmap** **Drive an omnichannel experience with our customers representing the field facing channel** **CFA capabilities are functioning as intended** **Related business processes are executed to ensure capabilities continue to be fully realized** **Processes are aligned with compliance requirements** **Core strategic platform upgrades are prepared for from a business perspective** **Operational issues are triaged and addressed in a manner that meets the needs of the business** **Responsibilities and deliverables include, but are not limited to:** **Drive creation of planned approach, identify expert stakeholders for engagement and contribution to scope of work** **Facilitate close collaboration with US Market Operations, Sales Operations, Communication and other critical stakeholder teams to execute against planned approach** **Engage with legal, compliance, and other similar bodies to seek guidance and alignment on new/novel approaches for customer interactions with the field** **Communicate with senior Sales and Account Leadership to align on approach, share progress, and for risk mitigation** **Partnering with technical and/or strategic partners to lead the implementation of capabilities** **Define and execute against a plan to measure success** **Required Education:** **Bachelor's degree** **Required Experience and Skills:** **Strong project management skillset** **Business analysis, problem solving, understanding of sales and marketing strategic priorities** **Minimum 3 years' experience in Sales/Marketing Operations, field sales, or account management** **Demonstrated ability to collaborate, plan and execute** **Experience in the development or implementation of capabilities (e.g., requirements definition, user acceptance testing)** **Communication and cross-functional collaboration** **Business process design/re-design** **Strategic thinking, business acumen, problem solving, understanding of sales and marketing** **Ability to negotiate and influence key stakeholders, and lead without authority** **Strong verbal and written communication skills** **High Compliance IQ: A strong understanding of field sales policy and compliance priorities within a pharmaceutical organization, including the ability to apply to a variety of real-world scenarios.** **Ability to articulate customer-facing challenges or opportunities to simplify and improve processes to a large matrix cross functional team** **Leadership Skills including:** **Entrepreneurship: Having patient and customer orientation; placing a high priority on the internal or external customer's perspective when making decisions and taking action; implementing service practices that meet the customers' and own organization's needs.** **Ownership and Accountability: taking ownership; setting high standards of performance for self and others; assuming responsibility and accountability for successfully completing assignments or tasks; self-imposing standards of excellence rather than having standards imposed** **Execution Excellence: taking prompt action to accomplish work goals, per compliance standards; taking action to achieve results beyond what is required; being proactive.** **Strategic Planning - prioritizing and planning; establishing an action plan for self and others to complete work efficiently and on time by setting priorities, establishing timelines, leveraging resources** **Change Catalyst: demonstrating adaptability; maintaining effectiveness when experiencing major changes in work responsibilities or environment (e.g., people, processes, structure, or culture); adjusting effectively to change by exploring the benefits, trying new approaches and collaborating with others to make the change successful** **Preferred Experience and Skills:** **Experience working in Veeva** **Passion for working with technology products and solving consumer needs** **Knowledge/experience with the US marketplace** **Understanding of launch products and timelines** **Required Skills:** Account Management, Account Management, Adaptability, Agile Methodology, Animal Health Sales, Business Acumen, Business Management, Business Processes, Communication, Company Due Diligence, Creative Campaign Development, Customer Engagement, Entrepreneurship, Interpersonal Relationships, Marketing, Marketing Budget Management, Marketing Data Analysis, Marketing Management, Marketing Strategy Implementation, Market Research, Pricing Strategies, Product Lifecycle Management (PLM), Product Roadmap, Project Management, Strategic Customer Development {+ 5 more} **Preferred Skills:** Current Employees apply HERE (***************************************************** Current Contingent Workers apply HERE (***************************************************** **US and Puerto Rico Residents Only:** Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here (*************************************** if you need an accommodation during the application or hiring process. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights (****************************************************************************************** EEOC GINA Supplement We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts (********************************************** **U.S. Hybrid Work Model** Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as "remote". The salary range for this role is $114,700.00 - $180,500.00 This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable. We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at ****************************************************** . You can apply for this role through **************************** (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting. **San Francisco Residents Only:** We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance **Los Angeles Residents Only:** We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance **Search Firm Representatives Please Read Carefully** Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. **Employee Status:** Regular **Relocation:** No relocation **VISA Sponsorship:** No **Travel Requirements:** 10% **Flexible Work Arrangements:** Remote **Shift:** 1st - Day **Valid Driving License:** No **Hazardous Material(s):** N/A **Job Posting End Date:** 12/17/2025 ***A job posting is effective until 11:59:59PM on the day** **BEFORE** **the listed job posting end date. Please ensure you apply to a job posting no later than the day** **BEFORE** **the job posting end date.** **Requisition ID:** R377014
    $114.7k-180.5k yearly 2d ago
  • Principal Controls Engineer, Operational Technology

    United Therapeutics Corporation 4.8company rating

    United Therapeutics Corporation job in Raleigh, NC

    California, US residents click here. The job details are as follows: Who We Are We are the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit corporation. Our public benefit purpose is to provide a brighter future for patients through the development of novel pharmaceutical therapies; and technologies that expand the availability of transplantable organs. United Therapeutics (Nasdaq: UTHR) seeks to travel down the corridors of indifference to develop treatments for rare, deadly diseases. We were founded in 1996 by a family seeking a cure for their daughter's pulmonary arterial hypertension (PAH). Today, we have six FDA-approved therapies that treat PAH, pulmonary hypertension associated with interstitial lung disease (PH-ILD) and neuroblastoma, a rare pediatric cancer. Our near-term pipeline seeks to develop additional therapies for PAH and pulmonary fibrosis (PF). The cure for end-stage life-threatening diseases like PAH, PH-ILD, PF, and many others is an organ transplant, but only a small percentage of donated organs are available to address the vast need. For this reason, we are working to create manufactured organs to address the shortage of kidneys, hearts, lungs, and livers available for transplant. We believe an unlimited supply of tolerable, transplantable organs will eliminate the transplant waiting list and cure end-stage organ diseases for which transplant is not currently an option. Who You Are You're a well-rounded expert in controls engineering and automation with an eye towards the future. We're counting on you to help guide our Operational Technology teams strategy as we expand operations and eventually look to explore new technologies including the expanded use of Machine Learning and Generative AI in support of our packaging, manufacturing and building automation needs. The Principal Controls Engineer will provide expert knowledge, guidance, and leadership in the design, implementation, and support of complex distributed control systems, manufacturing and packaging automation systems, and environmental monitoring systems including Schneider EcoStruxure, AVEVA (WW) Archestra, Delta V, and Elpro in a regulated, validated environment. * Provide leadership and guidance to the Operational Technology Automation team * Participate in and lead projects as a subject matter expert in automation systems for upgrades and/or new implementations. Provide expert support of distributed control systems, manufacturing and packaging automation systems, and environmental monitoring systems. * Troubleshoot and maintain PLCs, HMIs and field devices under strict change control. Perform preventative maintenance procedures on systems and/or equipment as required. Perform network troubleshooting, database troubleshooting, and code troubleshooting and revisions. * Collaborate with engineering, manufacturing, information technology, and validation teams on system configuration, network architecture, software requirements, graphics, programming, and sequence of operations * Review automation system specifications, programming standards and implementation plans. Verify standards are met; ensure GAMP/cGxP procedures and testing are followed. For this role you will need Minimum Requirements * Associate Degree in information technology or engineering or Bachelor's Degree in information technology or engineering * 12+ years of automation experience including PLC programming and connectivity, Industrial Networking and Schneider EcoStruxure, Wonderware Archestra, Delta V, and Elpro Environmental Monitoring with an Associate's Degree or 10+ years of automation experience including PLC programming and connectivity, Industrial Networking and Schneider EcoStruxure, Wonderware Archestra, Delta V, and Elpro Environmental Monitoring with a Bachelor's Degree * Prior experience working in an FDA regulated pharmaceutical manufacturing environment * Prior experience working on construction projects * Organizational skills including, but not limited to, the ability to handle multiple demands and assignments, the ability to prioritize tasks effectively and efficiently, and the ability to effectively manage resource procurement and utilization * Superior database maintenance / development experience * Computer hardware / software validation and change control experience * PLC programming and connectivity * Industrial Networking * Schneider EcoStruxure, AVEVA (WW) Archestra, and Delta V * Experience working in small, fast paced project teams; ability to work under pressure and adhere to deadlines Preferred Qualifications * 2+ years of supervisory experience * Certified Project Management Professional (PMP)-PMI Job Location United Therapeutics requires this candidate to be on-site at our Durham, North Carolina location 100% of the time. Approximately 15% travel is expected for this position. At United Therapeutics, our mission and vision are one. We use our enthusiasm, creativity, and persistence to innovate for the unmet medical needs of our patients and to benefit our other stakeholders. We are bold and unconventional. We have fun, we do good. Eligible employees may participate in the Company's comprehensive benefits suite of programs, including medical / dental / vision / prescription coverage, employee wellness resources, savings plans (401k and ESPP), paid time off & paid parental leave benefits, disability benefits, and more. For additional information on Company benefits, please visit ****************************************************** United Therapeutics Corporation is an Equal Opportunity Employer, including veterans and individuals with disabilities.
    $75k-106k yearly est. Auto-Apply 8d ago
  • Case Manager

    Johnson & Johnson 4.7company rating

    Raleigh, NC job

    At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at ******************* Job Function: Customer Management Job Sub Function: Customer Service Operations Job Category: Business Enablement/Support All Job Posting Locations: Orlando, Florida, United States of America, Phoenix, Arizona, United States, Pittsburgh, Pennsylvania, United States of America, Raleigh, North Carolina, United States Job Description: Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at *******************/innovative-medicine We are searching for the best talent for a Case Manager located in Pittsburgh, PA; Raleigh, NC; Orlando, FL; or Phoenix, AZ. Purpose: The Case Manager is a client-facing role responsible for responding to inquiries about patient programs, referral status, benefits verification, and financial assistance for Patient Service Center (PSC). They serve as the primary contact for Healthcare Providers (HCPs), patients, internal and external teams, ensuring clear communication, efficient case navigation, and access to therapy. Responsibilities: * Act as the primary point of contact and case manager for client, provider and customer inquiries and escalations. * Support patients and providers with program enrollment, benefits verification and referral to specialty pharmacies. * Conduct initial patient onboarding calls and ongoing support outreach. * Maintain regular communication to update all parties on case status and next steps. * Process PAP (patient assistance program) requests and re-approvals promptly. * Refer patients to external programs as appropriate * Identify and document adverse events and product complaints timely. * Independently manage an assigned territory making timely decisions for case resolution. * Demonstrate the ability to prioritize and balance the needs of patients, HCP offices utilizing program business. * Provide concierge-level service resolve issues efficiently and escalate when necessary. * Collaborate with field teams, manufacturer reps, providers, and internal/external teams to resolve complex cases. * Maintain accurate, compliant documentation and communication to support program goals. * Uphold patient privacy laws and foster collaborative team relationships. * Other duties as assigned. Required Qualifications: * High school diploma or equivalent. * Minimum of 4 years of working experience with at least 2 years' experience in customer service, call center, or insurance roles preferably within a healthcare or pharmacy setting. * Ability to work assigned 8 hr shift between program operating hours of 8am-8pm EST. * Strong communication and interpersonal skills with a focus on customer service. * Proven ability to manage a case load, prioritize tasks, and build relationships. * Ability to efficiently navigate multiple screens and systems to perform work. * Ability to proficiently use Microsoft programs. Preferred Qualifications: * Undergraduate degree * Certified Pharmacy Technician (CPhT) * Bilingual Spanish speaking and writing * Knowledge of benefit verification, foundation programs, plan types, and insurance structures. #Li-Remote Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via *******************/contact-us/careers, internal employees contact AskGS to be directed to your accommodation resource. Required Skills: Preferred Skills: Accountability, Communication, Customer Support Operations, Customer Support Trends, Detail-Oriented, Inquiry Handling, Issue Escalation, Process Oriented, Service Excellence
    $58k-74k yearly est. Auto-Apply 3d ago
  • Research Associate I - HLA/SLA

    United Therapeutics 4.8company rating

    United Therapeutics job in Morrisville, NC

    California, US residents click here (******************************************************************************************************************************************* . **The job details are as follows:** **Who We Are** We are the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit corporation. Our public benefit purpose is to provide a brighter future for patients through the development of novel pharmaceutical therapies; and technologies that expand the availability of transplantable organs. United Therapeutics (Nasdaq: **UTHR** ) seeks to travel down the corridors of indifference to develop treatments for rare, deadly diseases. We were founded in 1996 by a family seeking a cure for their daughter's pulmonary arterial hypertension ( **PAH** ). Today, we have six FDA-approved therapies that treat PAH, pulmonary hypertension associated with interstitial lung disease ( **PH-ILD** ) and neuroblastoma, a rare pediatric cancer. Our near-term pipeline seeks to develop additional therapies for PAH and pulmonary fibrosis ( **PF** ). The cure for end-stage life-threatening diseases like PAH, PH-ILD, PF, and many others is an organ transplant, but only a small percentage of donated organs are available to address the vast need. For this reason, we are working to create manufactured organs to address the shortage of kidneys, hearts, lungs, and livers available for transplant. We believe an unlimited supply of tolerable, transplantable organs will eliminate the transplant waiting list and cure end-stage organ diseases for which transplant is not currently an option. **Who You Are** The Research Associate I - HLA/SLA (Xeno/RMO) is responsible for assisting developing, validating, and performing immunogenetics testing to support xenotransplantation research and regulatory milestones. This role focuses on performing assays to characterize swine leukocyte antigen (SLA) and human leukocyte antigen (HLA) compatibility, optimizing crossmatch and antibody screening assays, and ensuring high-quality, reproducible data to guide clinical and preclinical decision-making. The position plays a key role in advancing translational research by collaborating with multidisciplinary teams to refine protocols, analyze results, and support regulatory submissions. + Perform routine and complex immunogenetics testing (e.g., PCR-based typing, Next-Generation Sequencing, Luminex/Intelliflex assays) on human and porcine samples + Assist in development, validation, and optimization of assays for histocompatibility testing (HLA/SLA) + Isolate, culture, and prepare PBMCs, endothelial cells, and other relevant cell populations for compatibility testing + Troubleshoot technical issues, maintain assay performance, and document deviations or corrective actions + Maintain and calibrate laboratory equipment, ensuring readiness for regulated testing and audits + Contribute to scientific manuscripts, abstracts, and conference presentations + Stay current with relevant literature, technologies, and regulatory guidelines in HLA/SLA testing and xenotransplantation research + Document all laboratory activities in compliance with GLP, CLIA, CAP, EFI, and/or FDA regulatory requirements + Assist in writing, reviewing, and updating SOPs, validation protocols, and quality records + Participate in internal audits, CAP inspections, and regulatory reviews + Assist in training junior staff and collaborators in proper laboratory techniques and assay workflows + Collaborate with clinicians and R&D scientists to design experiments and refine donor-recipient matching strategies Minimum Requirements + Bachelor's Degree in a related field + 1+ years of histocompatibility experience + Proficiency in laboratory techniques (pipetting, cell handling, molecular assays, flow cytometry) + Capacity to participate in multiple projects with competing timelines in a fast-paced research and clinical environment + Effective problem-solving skills to troubleshoot assay failures and identify root causes + Competence with electronic laboratory notebooks (ELN), LIMS systems, and basic bioinformatics workflows + Ability to work flexible hours including evenings and weekends on an ad hoc basis. Preferred Qualifications + ABHI - American Board of Histocompatibility and Immunogenetics Certified Histocompatibility Technologist (CHT) or Supervisor (CHS) + Strong understanding of immunogenetics, including HLA and SLA systems, antigen presentation, and transplant immunology + Familiarity with xenotransplantation models, including swine genetics, immunobiology, and donor-recipient matching considerations + Working knowledge of cell culture techniques, including PBMC and endothelial cell isolation and maintenance + Knowledge of crossmatch methodologies (CDC, flow cytometry) and interpretation of cytotoxicity/antibody binding data + Excellent technical documentation skills for SOP writing, assay reports, and regulatory submissions Job Location This job is an Onsite role requiring 5 days per week in the Morrisville, NC location. At United Therapeutics, our mission and vision are one. We use our enthusiasm, creativity, and persistence to innovate for the unmet medical needs of our patients and to benefit our other stakeholders. We are bold and unconventional. We have fun, we do good. Eligible employees may participate in the Company's comprehensive benefits suite of programs, including medical / dental / vision / prescription coverage, employee wellness resources, savings plans (401k and ESPP), paid time off & paid parental leave benefits, disability benefits, and more. For additional information on Company benefits, please visit ****************************************************** United Therapeutics Corporation is an Equal Opportunity Employer, including veterans and individuals with disabilities. _We strive to be an organization that engages the minds, hearts, and most spirited efforts of each of our employees. Our sense of purpose transforms what we do from work into mission, occupation into vocation and achievement into success._ _We challenge our employees with innovative and revolutionary projects, offer an environment which fosters high-level job performance and provide a highly competitive total rewards package. This is what makes United Therapeutics a stimulating place to work._
    $55k-72k yearly est. 38d ago
  • Technician Maintenance (SkillBridge)

    Merck 4.6company rating

    Durham, NC job

    **Job Requirements** Technician is a skilled technician with a moderate level of industry experience, responsible for performing routine operational and maintenance activities within an assigned suite or area. This role requires proficiency in mechanical and technical tasks, adherence to current Good Manufacturing Practices (cGMP), and a commitment to environmental, health, and safety (EH&S) standards. The Technician O2 works with moderate supervision, demonstrates mechanical aptitude, and actively contributes to team performance and process improvements. **Key Responsibilities** + **Operational Proficiency:** + Fully qualified to independently operate within the assigned suite or area + Performs all routine operational activities and preventative maintenance tasks independently. + Demonstrates mechanical aptitude and executes basic repairs for assigned equipment; + **Compliance and Documentation:** + Takes ownership of cGMP compliance, ensuring adherence to Standard Operating Procedures (SOPs), maintenance task lists, and proper documentation. + Proactively identifies and resolves compliance issues in the assigned suite, escalating to higher levels when necessary. + Maintains 100% training status without requiring coach input. + **Business Systems Proficiency:** + Proficient in business systems such as SAP, SAP Mobile, DeltaV, and other relevant platforms, performing tasks and transactions independently with minimal assistance. + **Problem Solving and Process Improvement:** + Recognizes operational and technical problems, using established procedures to assess and implement solutions. + Performs routine troubleshooting for assigned equipment or systems, escalating complex issues to higher-level technicians (O3/O4) as needed. + **EH&S and Team Accountability:** + Contributes to maintaining positive EH&S performance in the assigned area, actively identifying and resolving potentially unsafe conditions. + Demonstrates inclusion principles, collaborates with team members, and actively participates in team meetings, including Tier discussions. + Complies with safety and environmental regulations and guidelines. + **Work Management and Prioritization:** + Works independently to meet timeframes set by others, demonstrating reliability and follow-through on commitments. + Acts with urgency for emerging issues as directed by leadership. + **Leadership and Communication:** + Provides and receives timely, constructive one-on-one feedback to improve performance. + Listens, collaborates, and supports team decisions to meet collective goals. + **Additional Duties:** + Communicate with other departments, contractors, or disciplines + Assists with automation, validation, and additional testing as required. + Contributes to Continuous Improvement of existing processes + Complies with safety and environmental regulations and guidelines. + Other tasks that may be assigned by leadership **Work Experience** + **Minimum 3 years of plant maintenance or technical experience.** + Proficiency in **one** of the technical craft skills, including instrumentation, electrical, plumbing, or advanced mechanical systems. + Familiarity with regulatory requirements in accordance with cGMP manufacturing operations or other regulated industry. + Effective communication skills, both written and oral. + Ability to work with moderate supervision in non-routine situations. + This is a Skillbridge opportunity; candidates must be active duty military and eligible for Skillbridge opportunities. **Requisition ID:** P-100948
    $48k-63k yearly est. 4d ago
  • Supervisor, Bulk Manufacturing (Dry Powder Inhalation)

    United Therapeutics Corporation 4.8company rating

    United Therapeutics Corporation job in Raleigh, NC

    California, US residents click here. The job details are as follows: What We Do We build on the strength of our research and development expertise and a distinctive, entrepreneurial culture that encourages diversity, innovation, creativity, sustainability, and, simply, fun. Since inception, our mission has been to find a cure for pulmonary arterial hypertension and other life-threatening diseases. Toward this goal we have successfully gained FDA approval for five medicines, we are always conducting new clinical trials, and we are working to create an unlimited supply of manufactured organs for transplantation. We are the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit corporation (PBC). Our public benefit purpose is to provide a brighter future for patients through (a) the development of novel pharmaceutical therapies; and (b) technologies that expand the availability of transplantable organs. At the same time, we seek to provide our shareholders with superior financial performance and our communities with earth-sensitive energy utilization. Our company was founded by an entrepreneur whose daughter was diagnosed with a life-threatening condition. She sought to find treatment options and a cure for her daughter and patients like her. We are founder-led, and relentless in our pursuit of "medicines for life". We continue to research and develop treatments for cardiovascular and pulmonary diseases, and other orphan diseases. How you'll contribute United Therapeutics supplies Dry Powder Inhalation (DPI) medicines from the RTP, NC facility. This Supervisor is responsible for overseeing the setup, operation, and cleaning of all Bulk manufacturing operations equipment, ensuring that all machines within the supervised area(s), run efficiently and meet operations targets. The Bulk Supervisor will also lead a team of technicians, assigning tasks, monitoring performance, coaching and mentoring, and ensuring the smooth flow of operations across different workstations. * Provide leadership and guidance to technicians assigned to a given operations area, including but not limited to: performing and documenting all start-up checks, in-process checks, equipment adjustments, and batch reconciliations * Effectively direct and manage direct reports to include responsibilities for training, goal setting & achievement, coaching, mentoring; provide input to performance evaluations, and support career development, retention, and recruitment process. Promote open communication, address concerns promptly, and foster a positive and collaborative work environment while ensuring an uninterrupted operations flow. * Responsible for scheduling of operations personnel based on daily deliverables and personnel constraints * Effectively communicate operations needs and/or issues with leadership * Coordinate with warehouse staff for components needed for each operation; with QA staff for batch record issuance, room clearances and batch record checks as required; with manufacturing staff to issue labels and manage additional staffing needs; with maintenance staff for equipment troubleshooting and preventative maintenance * Ensure all operations completed in full compliance with company SOPs as well as GMPs. Ensure batch documentation as well as all cleaning records and labels are complete and accurate. Participate in resolving any non-conformance events; responsible for strict adherence to all OSHA and Company Safety Policies. * Author SOPs, batch documents and investigation reports * Perform all other duties as assigned For this role you will need Minimum Requirements * H.S. Diploma or General Education Degree (GED) * 9+ years of hands-on experience in a cGMP manufacturing, packaging or warehouse environment with a H.S. Diploma/GED or * 7+ years of hands-on experience in a cGMP manufacturing, packaging or warehouse environment with an Associates Degree or * 5+ years of hands-on experience in a cGMP manufacturing, packaging or warehouse environment with a Bachelor's Degree * Must have (or be willing and able to obtain) a valid Passport * Ability to navigate sophisticated equipment control systems on semi- and fully automated pharmaceutical equipment * Familiarity with the use and operation of in-process test equipment such as scales, balances, torque tester, and count checker * Experience with GMP documentation requirements * Must possess excellent written and oral communication skills * Ability to interact with other departments effectively * Ability to review work performed by other personnel, communicate problems and deficiencies, elicit corrections, and enforce company policy and procedures as they relate to manufacturing requirements * Ability to write and contribute to the development of SOP's and standard work instructions * Ability to work either a 24/5 or 24/7 work schedule Preferred Qualifications * Associates Degree or Bachelor's Degree in a relevant field * 2+ years of experience as an Operations Supervisor or equivalent * Knowledge of complex products and processes in a drug manufacturing facility At United Therapeutics, you'll realize quickly that it is not an ordinary place to work! When you join our company, you will learn, grow, contribute, have fun, and be challenged... all while making a difference in the lives of our patients. Eligible employees may participate in the Company's comprehensive benefits suite of programs, including medical / dental / vision / prescription coverage, employee wellness resources, savings plans (401k and ESPP), paid time off & paid parental leave benefits, disability benefits, and more. For additional information on Company benefits, please visit ****************************************************** United Therapeutics Corporation is an Equal Opportunity Employer, including veterans and individuals with disabilities.
    $74k-99k yearly est. Auto-Apply 4d ago
  • Manager, IT Engineering

    Gilead Sciences 4.5company rating

    Raleigh, NC 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 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 pursuing scientific invention to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. Gilead has operations in more than 35 countries worldwide, with headquarters in Foster City, California. You will be part of a team that is helping millions of people live healthier, more fulfilling lives. We are a close community where every individual matters and everyone has a chance to enhance their skills through ongoing development. Inclusion is one of our core values, which means we are creating and fostering a work environment where our differences are valued, and everyone feels respected and empowered to bring their authentic selves to work. Summary: This role sits within the global Gilead IT organization within the US Commercial Field Enablement IT team with the primary responsibility of supporting IT operations for Field Enablement applications. This role reports to the US Commercial IT Field Enablement lead. This role will support and liaise with a broad business team including Gilead Commercial Operations, Medical Affairs and Business Conduct. The role will also engage across IT teams who manage/support systems within the Capability ecosystem, i.e., integration touchpoints with tools such as Master Data Management platform and Commercial Analytics Hub as well as the broader IT team that enable the overall working experience for the business teams we support. This role would act as a liaison between CRM, Events and Account Management capability leads and the vendor MSP teams to manage and deliver on IT operations for field applications. This role would enable Next Gen CRM program by consolidating IT operations for field applications, quickly identifying and mitigating end user impacts and enabling focus on field experience with technology and IT change management. Some of the key activities that this role would lead include managing IT support operations teams, tracking and reporting on service requests and incidents, providing hands-on support and oversight for complex / priority tickets and escalations, participating in system testing and user acceptance testing, and managing deployment and hypercare. Core Tasks, Responsibilities & Scope of Authority: Utilize ServiceNow to record and track incidents, service requests including report requests Hands-on leadership and execution of IT support operations activities, working with MSP resources Engage with offshore service teams and onshore business and IT partners daily to deliver support operations Build and maintain a track of operational requests over time to advise leadership on trends with a key metric around first call resolution, warm transfers and minimizing field user time spent chasing IT support issues Support field events such as National Sales Meeting with onsite presence when necessary Proactive readiness and planning to support new product launches including onboarding field user groups Support launch of new applications such as Veeva Align, Next Gen CRM, ongoing platform and application enhancements Build and maintain relationships with individual field users and other support groups and product teams Lead IT operations for the field teams in a secure and compliant manner, adhering to appropriate SOPs and work instructions Additionally: Works closely with the respective Product Owners for Veeva / Vault CRM, Events Management, Align and other field applications to ensure end user experience for field applications remains positive Leads operational reporting services delivered within the platform / application using Salesforce / Vault platform reporting, MyInsights / X-Pages Basic Qualifications: Doctorate OR Master's and 4+ years of relevant experience OR Bachelor's and 6+ years of relevant experience OR Preferred Qualifications: Strong techno-functional knowledge of Veeva Commercial Cloud, including but not limited to Align, Veeva / Vault CRM, Veeva Events Management as well as Salesforce platform, Vault platform Strong problem-solving skills, experience in identifying and preventing issues from recurring, debugging and fixing code Ability to prioritize incidents and service requests based on priority levels and knowledge of support escalation paths High level of personal integrity consistent with Gilead's core values (Excellence, Accountability, Teamwork, Integrity and Inclusion) Service-oriented, willingness to put in the extra yards to provide an outstanding experience to end users Experience working in a multi-vendor scenario; vendor management experience is a plus Strong communication skills to engage directly with business users, IT and vendor teams Knowledge of ITIL framework and best practices Knowledge of working with ServiceNow IT service management platform The salary range for this position is: $126,565.00 - $163,790.00. 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.
    $126.6k-163.8k yearly Auto-Apply 2d ago
  • Lead Site Auditor

    Merck 4.6company rating

    Durham, NC job

    The Quality Associate Director/GMP Lead Site Auditor will have leadership responsibility for the site internal audit program, encompassing the full scope of site operations. Collaboration is required with site leadership, regional compliance leadership and Divisional Quality Assurance to elevate site audit program to achieve excellence and ensure program is effective. The position requires ability to lead and perform the operational aspects of the audit program, apply risk-based principles, communicate results to stakeholders, and evaluate/verify CAPA closure. Position requires risk communication related to the totality of audit and inspection findings at the site. Ability to lead an audit program that is focused on early detection and robust remediation of observation across the site. Ability to play a lead role in hosting Health Authority inspections and Divisional Audits at the site. **Position Responsibilities:** + Actively manage, mentor, and support site auditors to ensure performance of auditors contributes to the effectiveness of the site audit program + Function as a change agent related to culture and audit program performance + Lead change and process improvement initiatives related to Auditing, Inspections, CAPA, and other compliance topics + Perform routine risk communication pertaining to audits/inspection to Site, Regional, and Divisional Management + Mentor new auditors to ensure comprehensive training and full understanding of auditor roles and responsibilities + Achieve and maintain auditor qualification status through robust training and continuing education + Lead training/orientation for new Quality Auditing staff + Ensure preparation of annual audit schedule, using risk-based approaches + Schedule and perform assigned audits for site program. + Ensure timelines and quality of content for audit execution (audit pre-work, conducting audit, issuance of audit report, CAPA review and verification) meet established expectations. + Perform, lead, and mentor other auditors during site audits; participate in opportunities to audit at regional sites + Review, and approve Audit Reports + Actively monitor, report and trend observations/CAPAs, along with standard site audit metrics to Quality Council and Management + Actively participate and take a leadership role in the Auditor Community of Practice and Guest Auditor Program + Review and ensure CAPA responses to Audits and Inspections are robust + Perform a risk-based verification and effectiveness check on key CAPAs from audits and inspections + Recommend and lead implementation of improvements to the Audit and Inspection Management programs based on new regulations, guidance documents, and industry standards + Lead company and site preparation activities for support of regulatory and customer inspections + Provide compliance advice to site, development and commercial product teams + Supports and continually enhance the ongoing site Permanent Inspection Readiness status + Obtain and maintain cutting-edge knowledge and auditing techniques across applicable technical/Quality topics **Education Minimum Requirement:** + Bachelor's degree in engineering, Biology, Chemistry or related field **Required Experience and Skills:** + Minimum of five (5) years of manufacturing, technology, laboratory, and/or quality operations experience within GMP environment + GMP Compliance knowledge and proficiency in interpreting and applying domestic and international regulatory requirements + Knowledge of Quality Systems within a GMP environment + Demonstrated ability to establish and maintain collaborative relationships with key stakeholders + Ability to work independently with limited supervision + Ability to build relationships and influence across disciplines and all levels **Preferred Experience and Skills:** + GMP Audit experience in the pharmaceutical industry (CQA or other certification preferred) + Experience with leading effective audits and obtaining meaningful audit observations + "Subject Matter Expertise", including knowledge and demonstrated application in one or more of the following areas, based on site activities; Medical Device/Combination products, Biologics, Vaccines, API's or Non Sterile or Sterile Drug Product + Specific technical knowledge in areas pertaining to the hiring site (e.g, Quality Systems, Manufacturing, Testing/Stability, Microbiology testing, Packaging, Distribution, Data Integrity, Automation) + Knowledge of QBD development & submission requirements, as applicable to site + Ability to lead, motivate, develop and mentor other auditors + Knowledge of and experience in Quality Risk Management methods + Knowledge of US and European cGMP guidelines, ICH and other international regulatory requirements, as applicable + Experience with hosting or participating in Health Authority inspections and/or Divisional audits + Highly motivated, flexible, and have excellent organizational and communication skills + Excellent verbal and written communication skills + Ability to prioritize and balance work from multiple projects in parallel **Required Skills:** Accountability, Accountability, Aseptic Processing, Audit Management, Biological Sciences, cGMP Training, Customer-Focused, Detail-Oriented, Driving Continuous Improvement, Ethical Standards, GMP Compliance, Immunochemistry, Internal Auditing, IS Audit, Management Process, Medical Devices, Molecular Microbiology, Quality Auditing, Quality Control Documentation, Quality Control Management, Quality Management Systems (QMS), Quality Metrics, Quality Risk Assessment, Quality Risk Management, Regulatory Compliance Consulting {+ 5 more} **Preferred Skills:** Current Employees apply HERE (***************************************************** Current Contingent Workers apply HERE (***************************************************** **US and Puerto Rico Residents Only:** Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here (*************************************** if you need an accommodation during the application or hiring process. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights (****************************************************************************************** EEOC GINA Supplement We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts (********************************************** **U.S. Hybrid Work Model** Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as "remote". The salary range for this role is $126,500.00 - $199,100.00 This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable. We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at ****************************************************** . You can apply for this role through **************************** (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting. **San Francisco Residents Only:** We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance **Los Angeles Residents Only:** We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance **Search Firm Representatives Please Read Carefully** Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. **Employee Status:** Regular **Relocation:** Domestic **VISA Sponsorship:** No **Travel Requirements:** 10% **Flexible Work Arrangements:** Hybrid **Shift:** 1st - Day **Valid Driving License:** No **Hazardous Material(s):** N/A **Job Posting End Date:** 12/24/2025 ***A job posting is effective until 11:59:59PM on the day** **BEFORE** **the listed job posting end date. Please ensure you apply to a job posting no later than the day** **BEFORE** **the job posting end date.** **Requisition ID:** R375871
    $63k-80k yearly est. 3d ago
  • Neuro Sales Representative - Raleigh

    Johnson & Johnson 4.7company rating

    Raleigh, NC job

    At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at ******************* Job Function: Pharmaceutical Sales Job Sub Function: Sales - Neuroscience (Commission) Job Category: Professional All Job Posting Locations: Raleigh, North Carolina, United States : Neuro Sales Representative - Raleigh At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at *******************/. Johnson & Johnson has entered into an agreement to acquire Intra-Cellular Therapies, Inc, a biopharmaceutical company focused on the development and commercialization of therapeutics for central nervous system (CNS) disorders. With a differentiated commercialized therapy and promising clinical-stage pipeline that complements our current areas of focus, this acquisition brings us one step closer to achieving our ambition of becoming the #1 neuroscience company worldwide. Intra-Cellular Therapies, a Johnson & Johnson company, is on the path to be the #1 leader in neuroscience. With an exceptional suite of products and a commitment to transforming patient lives, we are expanding our CAPLYTA medical team to support our growing impact in psychiatry. The Neuroscience Sales Representative has overall responsibility for meeting or exceeding sales expectations within their assigned geographies in an ethical and compliant manner. The NSR is responsible for understanding and identifying customer needs, aligning marketing resources and supporting pull-through activities. They are also accountable for embodying and communicating Intra-Cellular's corporate vision of delivering innovative treatments to improve the lives of individuals with neuropsychiatric, neurologic, and other disorders to improve the lives and reduce the burden on patients and caregivers. The Neuroscience Sales Representative will develop superior product and disease state knowledge that allows them to compliantly engage in in-depth clinical dialogue with healthcare professionals. Additionally, they will have responsibility for the creation of local strategic and tactical plans, differential resource allocation, and accountability for effective application of budget and expense management within their assigned territory. We are looking for sales professionals who have a passion for patients, tenacity for results, ability to adapt and evolve, entrepreneurial thirst for working in an energizing and winning culture. Job Responsibilities: Following compliance guidelines, drives sales performance to ensure sales forecasts are met or exceeded within assigned territory by calling on predominantly Primary Care HCP offices and select PC targets within both in-person and virtually. Develop superior product and disease state knowledge and effectively educate and engage healthcare professionals in dialogue about clinical evidence, approved indications, and product efficacy/safety profiles to support on-label prescribing for appropriate patients. Effectively uses assigned budgets to achieve territory objectives. Customizes discussions and client interactions based on customer's needs in a compliant and ethical manner. Function independently with sales proficiency to drive sales performance and ensure sales forecasts and assigned budgets meet or exceed therapeutic and territory expectations. Maintains current understanding of local market, practice structures, evolving customers, and key influencers. Routinely shares such information with relevant internal Intra-Cellular stakeholders. Provides input into resource allocation decisions across customers/region. Identifies and selects programs/resources available and appropriate for each customer, practice, and/or system. Provides special education to healthcare providers through appropriate programs that fall within ITCI's ethical guidelines. Works with District Manager and key stakeholders to develop a local business plan that ensures achievement of all business objectives. Capitalizes on formulary approvals and other business opportunities through effective implementation of the strategic plan. Collaborates with other Neuroscience Sales Specialist-II's on common objectives and sharing of best practices. Accountable for providing timely and accurate administrative management of work hours, sales call data, customer objectives, communication responses, synchronization, sample and expense reporting. Expected to meet or exceed all NSR deliverables. Effectively create and build a compliant business plan based on depth and breadth of customer business needs, resources and products. Complete all company and job-related training as assigned within the required timelines. Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice. Job Requirements: Must have Bachelor's degree from an accredited college or university as well as a valid driver's license and safe driving record. Must have 1+ years of documented success in B2B sales experience required; previous sales experience in pharmaceuticals, biologics, and/or medical device sales preferred Antipsychotic, and/or bi-polar sales experience is a plus. Must have strong desire and passion for improving the lives of patients and their caregivers. Ideal candidate emulates patient-centricity. Must act with high integrity and always in accordance with the Company's Compliance policies and procedures. Must have strong sense of self-motivation, initiative, and entrepreneurial thirst, excellent decision-making judgment, strong teaming/collaboration and cross-functional skills. A proven track record of success in learning and adapting to an evolving environment such as Covid-19 in order to overcome obstacles and challenges. Must have ability to be agile and adapt to the changing telemedicine/virtual environment. Ability to analyze data/metrics to assess progress against objectives as well as diagnose performance issues and identify new opportunities. Must have strong verbal, presentation, and listening skills. Experience establishing new customer relationships and communicating technical information to a diverse customer audience. Work hours may include meetings scheduled outside of normal working hours. Territories may require some overnight travel depending on geography. Some domestic travel to corporate headquarters, training and sales meetings will also be required on a periodic basis. Must be able to perform all essential functions of the position, with or without reasonable accommodation. #ITCIBuild2025 Salary range for this position: $79,000 - $130,000 Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via *******************/contact-us/careers . internal employees contact AskGS to be directed to your accommodation resource. About Johnson & Johnson At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at *******************/. Required Skills: Preferred Skills: Analytical Reasoning, Business Behavior, Clinical Experience, Communication, Cross-Functional Collaboration, Cultural Competence, Customer Centricity, Data Savvy, Developing Partnerships, Execution Focus, Market Knowledge, Neuroscience, Pharmaceutical Industry, Pharmaceutical Sales Marketing, Problem Solving, Report Writing, Sales, Sales Support, Sales Trend Analysis, Strategic Sales Planning
    $42k-61k yearly est. Auto-Apply 28d ago
  • Senior District Manager, Advanced Oral Dermatology

    Johnson & Johnson 4.7company rating

    Raleigh, NC job

    At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at ******************* Job Function: Pharmaceutical Sales Job Sub Function: Sales - Immunology (Commission) Job Category: People Leader All Job Posting Locations: Camden, New Jersey, United States, Charleston, West Virginia, United States, Horsham, Pennsylvania, United States of America, Philadelphia, Pennsylvania, United States, Pittsburgh, Pennsylvania, United States of America, Raleigh, North Carolina, United States, Washington, District of Columbia, United States of America Job Description: Johnson & Johnson Innovative Medicine is recruiting for a Senior District Manager, Immunology-Dermatology, to support the Mid-Atlantic Advanced Oral team which includes Pittsburgh, PA, Charleston, WV, Philadelphia, PA, Raleigh, NC, Camden, NJ, Washington, DC, Wilmington, NC, Lancaster, PA, and Columbia, SC. Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Our Immunology team leads in the development of transformational medicines for immunological disorders and illnesses. You can influence where medicine is going by restoring health to millions of people living with immune diseases. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at *******************/innovative-medicine The Sr. District Manager (SDM) is a field-based role reporting to a Region Business Director. As a Sr. DM, you will: * Lead a diverse group of sales professionals to foster a culture of high performance, engagement and talent development * Manage and coach team to develop and execute high impact territory business plans for leading products and win for the patients * Continuously develop and demonstrate business, clinical and access acumen to compliantly guide the team to capitalize on opportunities in a highly competitive, dynamic environment * Connect and collaborate with internal and external customers to identify challenges/opportunities/solutions Required Qualifications: * A minimum of a Bachelor's degree is required * At least two (2) years of successful management and/or supervisory experience. * Five (5) or more years of documented successful pharmaceutical, biologic/biotech, or medical device sales experience in a competitive environment. * A valid Driver's License in one of the 50 United States * Ability to travel up to 60% * Reside within the geography or be willing to relocate to it Preferred Qualifications: * Knowledge of the Immunology/Dermatology field * Knowledge of Institutions in the district * Knowledge of access and fulfillment processes for biologic therapies Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via *******************/contact-us/careers and internal employees contact AskGS to be directed to your accommodation resource. Required Skills: Preferred Skills: The anticipated base pay range for this position is : $141,000-$243,800 Additional Description for Pay Transparency: Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. Subject to the terms of their respective plans, employees are eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)). This position is eligible to participate in the Company's long-term incentive program. Subject to the terms of their respective policies and date of hire, Employees are eligible for the following time off benefits: Vacation -120 hours per calendar year Sick time - 40 hours per calendar year; for employees who reside in the State of Washington -56 hours per calendar year Holiday pay, including Floating Holidays -13 days per calendar year Work, Personal and Family Time - up to 40 hours per calendar year Parental Leave - 480 hours within one year of the birth/adoption/foster care of a child Condolence Leave - 30 days for an immediate family member: 5 days for an extended family member Caregiver Leave - 10 days Volunteer Leave - 4 days Military Spouse Time-Off - 80 hours Additional information can be found through the link below. *********************************************
    $141k-243.8k yearly Auto-Apply 8d ago
  • NeuroPsych Account Specialist - Cary NC

    Neurocrine Biosciences 4.7company rating

    Cary, NC job

    Who We Are: At Neurocrine Biosciences, we pride ourselves on having a strong, inclusive, and positive culture based on our shared purpose and values. We know what it takes to be great, and we are as passionate about our people as we are about our purpose - to relieve suffering for people with great needs. What We Do: Neurocrine Biosciences is a leading neuroscience-focused, biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs. We are dedicated to discovering and developing life-changing treatments for patients with under-addressed neurological, neuroendocrine and neuropsychiatric disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia, endometriosis* and uterine fibroids,* as well as a robust pipeline including multiple compounds in mid- to late-phase clinical development across our core therapeutic areas. For three decades, we have applied our unique insight into neuroscience and the interconnections between brain and body systems to treat complex conditions. We relentlessly pursue medicines to ease the burden of debilitating diseases and disorders because you deserve brave science. For more information, visit neurocrine.com, and follow the company on LinkedIn, X and Facebook. ( *in collaboration with AbbVie ) About the Role:Responsible for a specific geographic territory and the successful promotion and growth of Neurocrine products. Manages and develops long-term relationships with physicians and other customers for targeted accounts in their assigned territory and represent Neurocrine brand(s) and their approved indications. This role also plays an important part in educating external customers such as physicians, nurses, medical assistants, case managers, etc. and helping them learn about the benefits of our product(s). _ Your Contributions (include, but are not limited to): Sales and Market Development Drives product acceptance and growth through targeted education and strategic account management Executes territory sales strategies to meet or exceed objectives via in-person and virtual communications Identifies and addresses territory-specific opportunities and barriers to product success Effectively manages promotional resources and budget Customer Relationship Management Builds and maintains relationships with key stakeholders including: Healthcare providers (Psychiatrists, Neurologists, NPs, PAs) Clinical staff (RNs, LPNs, PharmDs) Key opinion leaders and advocacy groups Community Mental Health Clinics and Long Term Care facilities Local/regional payers and pharmacies Cross-Functional Collaboration Establishes excellent communication with internal partners including managed care, Marketing, Patient Access, Medical Science Liaisons, and medical communications teams Professional Standards Upholds highest ethical standards, including FDA guidelines and pharmaceutical industry best practices Demonstrates integrity and models behaviors consistent with company values and compliance policies Work Expectations Maintains full field presence Monday-Friday with flexibility for occasional evening/weekend events Other duties as assigned Requirements: BS/BA degree in science or related field AND Minimum of 4 years of commercial pharma/biotech or related experience, including 3+ years of specialty pharmaceutical or LTC, Psychology, or Neurology sales experience is highly desired. Close-door or specialty pharmacy distribution experience is strongly preferred. Psychiatry, neurology or antipsychotic experience strongly preferred. Experience with business systems, salesforce automation platforms, and other business intelligence tools (e.g., Salesforce.com, Oracle database, SAP, Business Objects, COGNOS, QlikView, Veeva, etc.) OR Master's degree in science or related field AND 2+ years of similar experience noted above Professional Expertise Knowledge of best practices in the functional discipline and broader related business concepts Strong understanding of healthcare regulatory and enforcement environments Proven track record of meeting/exceeding sales objectives and launch success in complex environments Developing internal reputation in area of expertise Continuously works to improve tools and processes Leadership & Teamwork Ability to lead and participate in cross-functional teams Exhibits leadership skills, typically directing lower levels and/or indirect teams Builds trust and support among peers Acts as a settling influence in challenging situations Technical Skills Strong computer skills and working knowledge of business systems Proficiency with sales platforms and business intelligence tools (Salesforce.com, Oracle, SAP, Veeva, etc.) Excellent project management abilities Critical Thinking Sees broader organizational impact across departments/divisions Excellent analytical thinking and problem-solving skills Intellectual curiosity and ability to challenge status quo Able to decide and act without having the complete picture Communication & Relationship Management Excellent verbal and written communication skills Strong sales and account management disposition Ability to navigate complex accounts across varied care sites Understanding of specialty fulfillment and payer requirements Personal Attributes Results-oriented with high ethical standards Adaptable and effective in managing change Ability to meet multiple deadlines with accuracy and efficiency Thrives in performance-based, fast-paced environments Versatile learner who enjoys unfamiliar challenges Derives satisfaction through purposeful, passionate work Entrepreneurial attitude/experience Job-Specific Requirements Should reside within the geographic area of the assigned territory Valid driver's license and clean driving record (position requires frequent driving) Neurocrine Biosciences is an EEO/Disability/Vets employer. We are committed to building a workplace of belonging, respect, and empowerment, and we recognize there are a variety of ways to meet our requirements. We are looking for the best candidate for the job and encourage you to apply even if your experience or qualifications don't line up to exactly what we have outlined in the job description. _ The annual base salary we reasonably expect to pay is $120,600.00-$165,000.00. Individual pay decisions depend on various factors, such as primary work location, complexity and responsibility of role, job duties/requirements, and relevant experience and skills. In addition, this position is eligible participate in the Company's quarterly incentive compensation plan, which provides the opportunity to earn additional compensation based on individual performance results. This position is also eligible to participate in our equity based long term incentive program. Benefits offered include a retirement savings plan (with company match), paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage in accordance with the terms and conditions of the applicable plans.
    $52k-68k yearly est. Auto-Apply 17d ago
  • Regional Medical Scientific Director (Medical Science Liaison) - GI Immunology - Mountain West (MT, WY, UT, CO, NM) (Remote)

    Merck 4.6company rating

    Raleigh, NC job

    Responsibilities** + The Regional Medical Scientific Director (RMSD) is a credentialed (i.e., PhD, PharmD, DNP, MD) therapeutic and disease expert who engages in bidirectional exchange of scientific or medical information with Scientific Leaders (SLs). This MSL-type role provides balanced, factual, scientific information about non-product areas of interest to the Company and replies to scientific questions from SLs, including questions about Company products. The work of an RMSD is aligned to: Scientific Exchange, Research, Scientific Congress Support, and Scientific Insights. + RMSDs liaise between the scientific community and the Company to enhance the comprehension of scientific foundations and goals for approved, in-development, and active Company-sponsored trials and/or investigator-sponsored research studies. The RMSD serves as a role model for other field medical team members in ways that include on-boarding and/or sharing of therapeutic expertise. + This position will support our Company's Gastrointestinal (GI) Immunology program **Location details:** This role covers MT, WY, UT, CO, & NM. Candidates **must** reside within the territory; preference for the Denver and Salt Lake City areas. Travel up to 50% within the territory. **Responsibilities** **and Primary Activities** **Scientific Exchange** + Develops professional relationships and engages with national and regional SLs to ensure access to company-approved medical and scientific information on areas of therapeutic interest and Company products + Conducts peer-to-peer scientific discussions and maintains a reliable presence with those SLs to ensure they have a medical contact within the company + Addresses scientific questions and directs SL inquiries on issues outside of RMSD scope (e.g., grants) to appropriate company resources consistent with applicable policies + Maintains current knowledge and comprehension of dynamic scientific and clinical environment in the Company's Areas of Interest (AOI) for the RMSD's specific therapeutic area. **Research** + Upon request from Global Center for Scientific Affairs (GCSA), + Initiates discussions with SLs and/or potential investigators that include scientific/data exchange within our AOI to determine the alignment with our research strategies, studies concepts, scientific merit, and qualifications for a specific compound or trial + Enhances the comprehension of the scientific foundations and goals of investigator-sponsored research + Identifies barriers to patient enrollment and retention efforts to achieve study milestones + Upon request from Global Clinical Trial Operations (GCTO), + Recommends study sites and identifies potential investigators to participate in phase II-IV clinical development programs, conducts Site Initiation Visits (SIVs), and detects barriers to patient enrollment and retention efforts to achieve study milestones. + Protocol lead responsibilities in collaboration with GCTO + Addresses questions from investigators and provides information regarding participation in Company-sponsored clinical studies **Scientific Congress Support** + Engages in scientific congresses and medical meetings, facilitates scientific and data exchange for both Company and competitor data. **Scientific Insights** + Gathers feedback, data, or information during routine activities that can help the company better comprehend medical or scientific needs, priorities, or concerns of SLs and/or patients **Inclusive Mindset and Behavior** + Demonstrates eagerness to contribute to an environment of belonging, inclusion, equity, and empowerment + Leads by example and serves as a role model for creating, leading, and retaining a diverse and inclusive workforce **Required** **Qualifications** **, Skills, & Experience** **Minimum** + PhD, PharmD, DNP, DO, or MD + Proven competence and a minimum of 3 years of relevant therapeutic area experience beyond that obtained in the terminal degree program + Ability to conduct doctoral-level discussions with key external stakeholders + Dedication to scientific excellence with a strong focus on scientific education and dialogue + Excellent stakeholder management, communication, and networking skills + A thorough comprehension of FDA, OIG, HIPAA, and other ethical guidelines, laws, and regulations relevant to the pharmaceutical industry and its customers + Ability to organize, prioritize, and work effectively in a constantly changing environment + Strong working knowledge of Microsoft Office Suite (Word, PowerPoint, Excel, Teams, OneNote) + Familiarity with virtual meeting platforms + Desire to contribute to an environment of belonging, engagement, equity, and empowerment by: + Working to transform the environment, culture, and business landscape + Leveraging diversity and inclusion to ensure business value, per global diversity and inclusion strategy + Ensuring accountability to drive an inclusive culture + Strengthening the foundational elements of diversity + Consistent adherence to field and corporate policies and Global Medical Scientific Affairs (GMSA) strategy, including field standard operating procedures (SOPs), Good Clinical Practice (GCP) guidelines, and administrative/operational responsibilities **Preferred** + Field-based medical experience + Research Experience + Demonstrated record of scientific/medical publication \#eligiblefor ERP **Required Skills:** Clinical Research, Clinical Trials, Gastroenterology, Gastrointestinal Disease, Medical Affairs, Medical Relations, Pharmaceutical Medical Affairs, Stakeholder Engagement **Preferred Skills:** Current Employees apply HERE (***************************************************** Current Contingent Workers apply HERE (***************************************************** **US and Puerto Rico Residents Only:** Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here (*************************************** if you need an accommodation during the application or hiring process. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights (****************************************************************************************** EEOC GINA Supplement We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts (********************************************** **U.S. Hybrid Work Model** Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as "remote". The salary range for this role is $187,000.00 - $294,400.00 This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable. We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at ****************************************************** . You can apply for this role through **************************** (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting. **San Francisco Residents Only:** We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance **Los Angeles Residents Only:** We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance **Search Firm Representatives Please Read Carefully** Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. **Employee Status:** Regular **Relocation:** No relocation **VISA Sponsorship:** No **Travel Requirements:** 50% **Flexible Work Arrangements:** Remote **Shift:** Not Indicated **Valid Driving License:** Yes **Hazardous Material(s):** n/a **Job Posting End Date:** 12/13/2025 ***A job posting is effective until 11:59:59PM on the day** **BEFORE** **the listed job posting end date. Please ensure you apply to a job posting no later than the day** **BEFORE** **the job posting end date.** **Requisition ID:** R364045
    $89k-122k yearly est. 60d+ ago
  • Cloud Platform Engineering Architect (AWS)

    Gilead Sciences 4.5company rating

    Raleigh, NC 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 Gilead Cloud Platform Engineering (CPE) Architect role will provide architectural leadership to the CPE DevOps Team on both delivery and support. Description of Responsibilities Gilead Cloud core platform services and automation development (design, development and delivery of technical code) for the AWS Control Tower Landing Zone Terraform development impacting AWS account baselines, CI/CD integration with the platform, DMZ networking, and SCP management Core platform and automation security hardening Maintenance and support of core platform automation, guardrails and Security Control Policies (SCPs). Platform development, coding, automation, role-based access control, authentication, Cyber Security hardening and cloud support Continuous Integration/Continuous Delivery (CI/CD): Design, build, and maintain CI/CD DevSecOps pipelines to automate the building, testing, and deployment of applications. This includes Integration of CI/CD pipelines via automation with other services including security scanning, artifact repositories, ITSM, etc. Infrastructure as Code (IaC): Manage and provision cloud infrastructure using tools such as Terraform to ensure consistent and repeatable deployments. Cloud infrastructure management: Deploy, manage, and optimize cloud-based resources on platforms like AWS and Microsoft Azure. Containerization and orchestration: Work with container technologies like Docker and orchestration systems like Kubernetes to manage and scale applications. Monitoring and logging: Implement monitoring, logging, and alerting solutions to track application performance, system health, and security issues. Security and compliance: Ensure that cloud environments and deployment practices adhere to security best practices and compliance standards. Collaboration: Work closely with application teams, security, and quality assurance to troubleshoot issues and streamline processes. Automation: Identify and automate manual and repetitive processes to increase efficiency and reduce human error. Leverage AI tools for improved automation and scale. Troubleshooting: Perform root cause analysis and provide technical support to resolve issues in development, testing, and production environments. Provide daily technical leadership and guidance to the Cloud Platform Engineering Core and CI/CD Engineering Scrum Team Education and Experience Required: Minimum Required Education and Years of Experience: High School Degree and Fourteen Year's Experience OR Associates Degree and Twelve Years Experience OR Bachelor's Degree and Ten Years' Experience OR Masters' Degree and Eight Years' Experience Public Cloud Services knowledge of AWS, MS Azure (a plus) Development (coding) skills required, Terraform and GitHub expertise required CI/CD DevSecOps opinioned pipelines subject matter expertise Professional certifications a plus (Public Cloud, Architecture, Program Management etc.) Agile/Scrum knowledge and leadership skills Knowledge and Skills Required: Subject matter expert on AWS, MS Azure Public Cloud services Deep knowledge in Public Cloud Infrastructure and Application Architectures Knowledgeable in all facets of compute, network and storage as it relates to Public Cloud Application Architecture Subject matter expert in AWS Cloud Control Tower Landing Zone (CTLZ) architecture Advanced knowledge of CI/CD DevSecOps opinioned pipelines and GitHub self-hosted runner architecture Advanced code writing in multiple languages to design and deliver Gilead Cloud CI/CD pipeline services (primarily AWS, Azure a plus) Code development in multiple languages preferred, expert skills in Terraform and GitHub required Understanding and capability to Lead an Agile Scrum Team Strong root cause analysis skills to troubleshoot and resolve support escalations for Gilead Cloud core services Develop and publish infrastructure and Application architecture designs ITSM subject matter expertise to assist with implementation, integration, governance and improvement Reporting and Analytics tools and development Program Management skills - set up meetings, facilitate, assign actions, track/ follow up and report out Proficient with Atlassian (Confluence and Jira), MS DevOps, MS Office, especially Outlook, Excel and PowerPoint. Use of large/complex Excel files will be required. GitHub expertise a must. Advanced written and verbal communication skills Specific job duties may vary and will flex to align with business requirements. The salary range for this position is: Raleigh: $168,980.00 - $218,680.00. 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.
    $195.7k-253.2k yearly Auto-Apply 19d ago

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