Regulatory Affairs Specialist OrganOxRegulatory Affairs SpecialistMadison, NJ$120,000–$135,000 / yearThe role works closely with Regulatory Affairs team members responsible for software, hardware, disposable products, labelling, and other regulatory disciplines to support submission activities, maintain accurate regulatory records, and ensure alignment across product areas and markets. It has been utilized in over 7,000 liver transplants to date to keep donor livers in a metabolically active state outside the body enabling longer preservation times and functional assessment of the organ prior to transplant, leading to an increased number of organs available for transplant.
Senior Policy Manager Pride Technologies LLCSenior Policy ManagerNew York, NY$70–$85 / hourThis applies to direct care staff (Examples: RN, LPN, Nurse Aides, Therapists) referred to Kentucky nursing facilities, assisted living communities, or long-term care facilities, in accordance with KRS 216.793. Develop and advocate for policies supporting the growth of biking and walking, public transit, and emerging mobility solutions by building relationships with elected officials and nonprofit leaders and leading advocacy campaigns.
NewAssociate Principal Scientist, Regulatory Affairs Merck & Co IncAssociate Principal Scientist, Regulatory AffairsRahway, NJ$142,400–$224,100 / yearExperience in biologics regulatory Chemistry, Manufacturing and Control in both pre-approval and registration required, with experience authoring agency interactions, responses to questions, and Investigational New Drug Application, Investigational Medicinal Product Dossier, and Biologics License Application sections. Required Experience and Skills: Prior Biologics Investigational New Drug Application (IND), License Application (BLA) and/or post approval filing experience with at least 10 years subject matter expertise in biologics Chemistry, Manufacturing, and Controls development or manufacturing.
NewVice President, Health Digital/Social Strategy FleishmanHillardVice President, Health Digital/Social StrategyNew York, NY$77,000–$175,000 / yearFleishmanHillard was named 2020, 2021 and 2022 Campaign Global PR Agency of the Year; 2023 ICCO Large Agency of the Year – The Americas; 2022 and 2023 PRWeek U.S. Agency of the Year; 2022 and 2023 PRWeek U.S. Outstanding Extra-Large Agency of the Year; 2023 Campaign US PR Agency of the Year; 2021 PRovoke APAC Consultancy of the Year; and 2021 PRWeek UK Large Consultancy of the Year. This is a critical role on our social and digital team, with the opportunity to support leading pharmaceutical companies—including work related to a first-of-its-kind treatment in an expanding area of medicine—and collaborate with talented colleagues across strategy, creative, analytics, media, and healthcare communications.
Regulatory Affairs Admin Asst Life's WORCRegulatory Affairs Admin AsstGarden City, New York$45,240–$48,000 / yearExcellent verbal & written communication skills, excellent organizational & time management skills, as well as excellent customer service skills. Assist with follow up on incident items needed from various departments to ensure incidents are completed/closed within the regulatory timeframe.
New Product Planning Manager, Digital and Connected Care Zoll Medical CorpNew Product Planning Manager, Digital and Connected CareParsippany, NJRemote$135,000–$155,000 / yearThe New Product Planning Manager, Digital & Connected Care, for ZOLL Cardiac Management Solutions is an upstream marketing role at the intersection of digital health, patient engagement, and physician workflow adoption in the care and treatment of acute heart disease. This role is responsible for shaping product strategy for digital and connected solutions in the ZOLL CMS portfolio that transform patient-facing digital experiences as well as how physicians consume, interpret, and act upon longitudinal insights generated from products in the ZOLL CMS portfolio.
Senior Associate, US Regulatory Affairs BeOne Medicines AGSenior Associate, US Regulatory AffairsNY$93,600–$123,600 / yearThe Sr Associate will assist the Regulatory Affairs team member on cross-functional project teams and will assist on authoring and preparation of annual reporting, and will manage regulatory submissions and regulatory archive. Essential Functions of the job: With minimal supervision, plan and manage regulatory activities related to assigned projects that span technical areas including clinical, non-clinical, and CMC.
Specialty Business Manager, Derm - Bronx, NY Takeda Pharmaceutical Co LtdSpecialty Business Manager, Derm - Bronx, NYBronx, NYRemote$63.51–$87.31 / hourEstablish professional working relationships with Health Care Providers decision makers, support staff, and other stakeholders within assigned customers, to support the safe and effective use of the company's products - through developing and applying clinical and business expertise, and effective selling skills. Develop and deliver a targeted sales message to HCPs to support patients' safe and effective use of assigned product based on accurate clinical information, utilizing approved marketing materials and medical reprints, and discuss therapeutic strategies to inform and educate decision makers.
Senior Regulatory Affairs Specialist - Software OrganOxSenior Regulatory Affairs Specialist - SoftwareMadison, NJ$115,000–$140,000 / yearUnder direction from the Director, Regulatory Affairs, Software and Innovation, the Senior Regulatory Affairs Specialist will be responsible for: · Providing regulatory affairs support for projects related to Digital Health, Software, Cybersecurity, Electromechanical devices and Regulatory Intelligence. Founded in 1921, Terumo Corporation strives to fulfill its mission of “Contributing to Society through Healthcare” by providing a comprehensive range of solutions in the fields of therapeutic procedures, hospital operations, and life sciences in more than 160 countries and regions.
NewManager, Clinical Science & Site Educator Alto Neuroscience IncManager, Clinical Science & Site EducatorNYRemote$160,000–$175,000 / yearWe are seeking an experienced Manager, Clinical Science & Site Education to lead a team responsible for providing scientific, clinical, and protocol-specific education to clinical trial sites. This role will oversee day-to-day site education and engagement activities, support team development and performance, and serve as a key liaison between Clinical Development, Clinical Operations, and investigational sites.
Principal / Director, Product Origination & Distribution Strategy, Insurance KKR & Co IncPrincipal / Director, Product Origination & Distribution Strategy, InsuranceNew York, NY$160,000–$250,000 / yearThe group partners closely with investment teams, commercial team, insurance leadership, and external clients and distribution partners to diversify KKR's funding sources and grow assets under management across new channels and geographies. Own the Defined Contribution channel strategy for insurance -building the roadmap for entry and scale and partnering with key leaders across both functions to define, evaluate, and recommend specific growth opportunities for insurance within Defined Contribution.
Oncology Nurse Practitioner Outpatient Leukemia and Lymphoma Hackensack University Medical CenterOncology Nurse Practitioner Outpatient Leukemia and LymphomaHackensack, NJThe Oncology Advanced Practice Nurse (APN) for outpatient Multiple Myeloma utilizes a patient-centered coordinated care model, demonstrating competencies in leadership, direct clinical practice, consultation/collaboration, coaching/guiding, research, and ethical decision-making. The posted rate of pay in this job posting is a reasonable good faith estimate of the minimum base pay for this role at the time of posting in accordance with the New Jersey Pay Transparency Act and does not reflect the full value of our market-competitive total rewards package.
PA/NP Emergency Medicine Per Diem Hackensack University Medical CenterPA/NP Emergency Medicine Per DiemHackensack, NJThe Per Diem Emergency Medicine Physician Assistant or Nurse Practitioner utilizes a patient-centered coordinated care model, demonstrating competencies in leadership, direct clinical practice, consultation/collaboration, coaching/guiding, research, and ethical decision-making. The posted rate of pay in this job posting is a reasonable good faith estimate of the minimum base pay for this role at the time of posting in accordance with the New Jersey Pay Transparency Act and does not reflect the full value of our market-competitive total rewards package.
NP/PA - Interventional Pain Management Hackensack University Medical CenterNP/PA - Interventional Pain ManagementHackensack, NJThe Nurse Practitioner or Physician Assistant for Interventional Pain Managemen utilizes a patient-centered coordinated care model, demonstrating competencies in leadership, direct clinical practice, consultation/collaboration, coaching/guiding, research, and ethical decision-making. The posted rate of pay in this job posting is a reasonable good faith estimate of the minimum base pay for this role at the time of posting in accordance with the New Jersey Pay Transparency Act and does not reflect the full value of our market-competitive total rewards package.
Senior Manager, Regulatory Affairs BeOne Medicines AGSenior Manager, Regulatory AffairsNY$139,800–$184,800 / yearThe Manager will represent Regulatory Affairs on cross-functional project teams, will provide input to the project team, will lead authoring and preparation of annual reporting, and will manage regulatory submissions. Essential Functions of the Job: With minimal supervision, plan and manage regulatory activities related to assigned projects that span technical areas including clinical, non-clinical, and CMC.
Senior Specialist, Regulatory Affairs ImmunityBio IncSenior Specialist, Regulatory AffairsSummit, NJImmunityBio, Inc. (NASDAQ: IBRX) is a commercial-stage biotechnology company developing cell and immunotherapy products that are designed to help strengthen each patient's natural immune system, potentially enabling it to outsmart the disease and eliminate cancerous or infected cells. ImmunityBio is developing cutting-edge technology with the goal to transform the lives of patients with cancer and develop next-generation therapies and vaccines that complement, harness and amplify the immune system to defeat cancers and infectious diseases.
2027 Future Talent Program - Global Regulatory Affairs - Oncology - Co-op Merck & Co Inc2027 Future Talent Program - Global Regulatory Affairs - Oncology - Co-opRahway, NJRequired Skills: Clinical Research, Cloud Data Catalog, Collaboration, Critical Thinking, Data Analysis, Database Management, Data Science, Data Security, Leading Project Teams, Life Science, Pharmaceutics, Regulatory Affairs Management, Regulatory Management, Regulatory Processes, Regulatory Reporting, Regulatory Submissions, Scientific Writing. 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.
NP/PA - Trauma Outpatient (Weekday) Hackensack University Medical CenterNP/PA - Trauma Outpatient (Weekday)Hackensack, NJThe Nurse Practitioner / Physician Assistant utilizes a patient-centered coordinated care model, demonstrating competencies in leadership, direct clinical practice, consultation/collaboration, coaching/guiding, research, and ethical decision-making. The posted rate of pay in this job posting is a reasonable good faith estimate of the minimum base pay for this role at the time of posting in accordance with the New Jersey Pay Transparency Act and does not reflect the full value of our market-competitive total rewards package.
NP/PA - General Neurology Inpatient Per Diem Night Hackensack University Medical CenterNP/PA - General Neurology Inpatient Per Diem NightHackensack, NJGeneral Neurology Inpatient APP Per Diem NIGHT utilizes a patient-centered coordinated care model, demonstrating competencies in leadership, direct clinical practice, consultation/collaboration, coaching/guiding, research, and ethical decision-making. The posted rate of pay in this job posting is a reasonable good faith estimate of the minimum base pay for this role at the time of posting in accordance with the New Jersey Pay Transparency Act and does not reflect the full value of our market-competitive total rewards package.
NP - OBGYN Outpatient Part Time Hackensack University Medical CenterNP - OBGYN Outpatient Part TimeNJThe Advanced Practice Nurse (APN) utilizes a patient-centered coordinated care model, demonstrating competencies in leadership, direct clinical practice, consultation/collaboration, coaching/guiding, research, and ethical decision-making. The posted rate of pay in this job posting is a reasonable good faith estimate of the minimum base pay for this role at the time of posting in accordance with the New Jersey Pay Transparency Act and does not reflect the full value of our market-competitive total rewards package.