Staff Engineer, Packaging - Wayne, NJ Getinge GroupStaff Engineer, Packaging - Wayne, NJWayne, NJWith a firm belief that every person and community should have access to the best possible care, Getinge provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows. Develop and approve validation strategies and protocols including: IQ, OQ, PQ, Process validation, Packaging validation, Package integrity testing, Transportation simulation testing, Accelerated and real-time aging studies, and Labeling system validation.
Principal Scientist, Clinical Research, Thoracic Oncology Merck & Co IncPrincipal Scientist, Clinical Research, Thoracic OncologyRahway, NJ$255,800–$402,700 / yearSpecifically, the Clinical Director may be responsible for: Evaluating pre-clinical and translational work for the purpose of generating early clinical development plan and Investigational New Drug applications; Developing of clinical development strategies for investigational or marketed Oncology drugs; Planning clinical trials (design, operational plans, settings) based on these clinical development strategies; Monitoring and managing the conduct of ongoing or new clinical trials for investigational or marketed Oncology drugs; Analyzing and summarizing the clinical findings from studies to support decisions regarding safety and efficacy as well as new drug applications, clinical study reports, or publication; and. The Clinical Director is responsible for maintaining a strong scientific fund of knowledge by: Maintaining awareness of scientific developments within his/her area of expertise, in terms of new scientific findings, research methodologies; Identification of scientifically and operationally strong investigators who can assist in the development of our companies investigational and marketed drugs; Establishing communications with prominent clinical investigators in his/her particular field of interest, particularly those who will be willing and able to assist in the evaluation of our drugs; and.
USA_Regulatory Associate - Level 3 LancesoftUSA_Regulatory Associate - Level 3Warren, NJCompetencies and Skills: Agile, attention to detail, written and verbal communication skills using evidence and applying judgement to. The purpose of this role is to execute OTC regulatory activities for new products registrations and life cycle.
Clinical Trial Associate Integrated Resources, IncClinical Trial AssociateWoodcliff Lake, New JerseyContractorOur methods include applying domain expertise in specific industry segments, utilizing a highly-skilled workforce, leveraging a proven global delivery model, implementing structured and scalable quality processes and methodologies and yet, staying cost-effective. Job Title: Clinical Trials Disclosure Associate Duration: 1 year+ Location: Woodcliff Lake, NJ The Clinical Disclosure Associate will work across multiple disciplines within and outside Regulatory Affairs to drive departmental and project objectives.
Director/Senior Director, Clinical Development MD Axsome Therapeutics IncDirector/Senior Director, Clinical Development MDNew York, NYRemote$240,000–$300,000 / yearOur industry-leading neuroscience portfolio includes FDA-approved treatments for major depressive disorder, excessive daytime sleepiness associated with narcolepsy and obstructive sleep apnea, and migraine, and multiple late-stage development programs addressing a broad range of serious neurological and psychiatric conditions that impact over 150 million people in the United States. The Director/Senior Director, Clinical Development will help shape clinical strategy, contribute to protocol design and key regulatory and clinical documents, and serve as a clinical representative with regulators, investigators, and cross-functional partners.
Medical Governance, Evidence and Operations Lead Novartis AGMedical Governance, Evidence and Operations LeadEast Hanover, NJ$75,880–$108,400 / yearExpected Annual Base Salary Range for role: 75,880.00 - 108,400.00 - 140,920.00 EUR Annual The base salary offered is determined based on gender-neutral objectives, such as relevant skills, competencies and experience in accordance with the Novartis pay setting policy and upon joining Novartis will be reviewed periodically. Lead evidence generation activities including observational studies, local clinical studies, and real-world evidence (RWE) programs aligned with integrated evidence plans and strategic priorities.
Associate Director, Health Authorities ImmunityBioAssociate Director, Health AuthoritiesSummit, 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. Lead external stakeholder engagement throughout the submission lifecycle, coordinating with CROs, external regulatory consultants, and subject matter experts / key opinion leaders to gather data, craft high‑quality RFI responses, and foster constructive agency relationships.
Senior Director of Provider Network Operations Metroplus Health Plan IncSenior Director of Provider Network OperationsNew York, NY$220,000–$230,000 / yearSuccess in this role will be measured by high-performing and successful provider partnerships, ensuring excellent provider experience, accuracy of our provider directory and optimal results with access and availability leading to positive member experiences. Required Education, Training & Professional Experience: Bachelor's Degree in Business Administration, Healthcare, or any analytical field required; Master's Degree preferred.
Director, Compliance Risk QcellsDirector, Compliance RiskTeaneck, NJFull timeBachelor’s degree or equivalent work experience and a minimum of 12+ years of professional work experience including 10+ years of experience in consumer lending regulatory compliance, preferably within fintech and/or bank partnership models and 5+ years of progressive leadership experience with direct people/team management. Mobility Standing 20% of time Sitting 70% of time Walking 10% of time Strength Pulling up to 10 Pounds Pushing up to 10 Pounds Carrying up to 10 Pounds Lifting up to 10 Pounds Dexterity (F = Frequently, O = Occasionally, N = Never) Typing F Handling F Reaching F Agility (F = Frequently, O = Occasionally, N = Never) Turning F Twisting F Bending O Crouching O Balancing N Climbing N Crawling N Kneeling N .
NewSr. Manager, Sustaining & LifeCycle Engineering Getinge ABSr. Manager, Sustaining & LifeCycle EngineeringWayne, NJ$190,000–$215,000 / yearLeads multidisciplinary Sustaining Engineering and Product Lifecycle Management teams to ensure the continued safety, quality, reliability, regulatory compliance, and profitability of commercially released products throughout their lifecycle. Directs and coordinates engineering activities related to design changes, product enhancements, component obsolescence, supplier changes, cost reduction initiatives, complaint investigations, CAPAs, and manufacturing support.
Sr. Director/Executive Director, R&D/Clinical QA Tris PharmaSr. Director/Executive Director, R&D/Clinical QAMonmouth Junction, NJ$235–$255 / yearEXECUTIVE DIRECTOR: Bachelors degree in science or related field and minimum 15 years quality and/or compliance experience in the pharmaceutical or biotechnology industry in positions of increasing technical responsibility (minimum 10 of those years in roles with Quality Assurance leadership and/or management responsibility within R&D or Clinical Development). SR DIRECTOR: Bachelors degree in science or related field and minimum 12 years quality and/or compliance experience in the pharmaceutical or biotechnology industry in positions of increasing technical responsibility (minimum 8 of those years in roles with Quality Assurance leadership and/or management responsibility within R&D or Clinical Development).
NewDirector, Medical Information Compass PathwaysDirector, Medical InformationNew York, NYRemote$210,000–$255,000 / yearWorking cross-functionally across Medical Affairs, Scientific Communications, Medical Education, Evidence Generation, Pharmacovigilance, Regulatory, Legal, Compliance, and Commercial, this individual will help ensure Medical Information strategies are aligned with broader organizational objectives and evolving scientific priorities. The Director will also be responsible for identifying opportunities to optimize Medical Information processes, leveraging insights from medical inquiries to inform Medical Affairs strategy, and driving innovation through best-in-class technologies, analytics, and service delivery models.
Director Commercial Quality US Teva Pharmaceutical Industries LtdDirector Commercial Quality USParsippany, NJ$173,000–$216,000 / yearThe Director Commercial Quality US is responsible for the Commercial Quality activities in the United States, covering the responsibilities of the US Quality Systems of product distribution, warehousing, importation, team budget and associated resources, compliance activities including complaints and recall management, regulatory event reporting, drug shortage reporting, Health Authority, US FDA interactions and expectations, continuous improvement initiatives, strategic business plans impacting quality and compliance such as new product launch quality oversight and quality regulatory compliance of commercial engagements (internal and external). Additional benefits include, but are not limited to, Employee Assistance Program, Employee Stock Purchase Plan, Tuition Assistance, Flexible Spending Accounts, Health Savings Account, Life Style Spending Account, Volunteer Time Off, Paid Parental Leave, if eligible, Family Building Benefits, Virtual Physical Therapy, Accident, Critical Illness and Hospital Indemnity Insurances, Identity Theft Protection, Legal Plan, Voluntary Life Insurance and Long Term Disability and more.
NewDirector, Medical Information Compass Pathways PlcDirector, Medical InformationNYRemote$210,000–$255,000 / yearWorking cross-functionally across Medical Affairs, Scientific Communications, Medical Education, Evidence Generation, Pharmacovigilance, Regulatory, Legal, Compliance, and Commercial, this individual will help ensure Medical Information strategies are aligned with broader organizational objectives and evolving scientific priorities. The Director will also be responsible for identifying opportunities to optimize Medical Information processes, leveraging insights from medical inquiries to inform Medical Affairs strategy, and driving innovation through best-in-class technologies, analytics, and service delivery models.
Director, Medical Safety Lead - DSPV, Gene Therapy Insmed IncDirector, Medical Safety Lead - DSPV, Gene TherapyNJRemote$247,000–$337,000 / yearFor New York City Residents: To assist in identifying candidates with qualifications matching those required and/or preferred for this role, Insmed uses an Automated Employment Decision Tool ("AEDT") that employs artificial intelligence to analyze and score information provided in resumes and application materials including, but not limited to, skills, work experience, education, and job-related qualifications. Work with the DSPV leadership to develop the strategy and implementation of safety and benefit-risk management for assigned products; develop key content of Risk Management documents (RMPs, REMS) for assigned products.
Staff Quality Specialist Katalyst Healthcares & Life SciencesStaff Quality SpecialistParsippany, NJRemoteAnalyze interactions and dependencies across QMS subprocesses including Change Control, Document Control, Training, CAPA, Nonconformance, Complaint Handling, Supplier Quality, Design Controls, Risk Management, Validation, Audits, and Management Review. Strong understanding of QMS subprocesses including Change Control, Document Control, CAPA, Nonconformance Management, Training, Audits, Supplier Quality, Design Controls, Risk Management, Validation, Complaints, and Management Review.
Manager Market Strategy & Analysis Calpine CorpManager Market Strategy & AnalysisRed Bank, NJ$91,895–$135,545 / yearThe primary focus of the position is retail electric markets in the Northeast and Midwest U.S. The candidate will support Calpine Retail supply, commercial and sales teams by (1) monitoring, analyzing and communicating key regulatory policy developments that may directly or indirectly impact the company and (2) advocating policies that enhance Calpine's business processes. Support Calpine Retail commercial, supply and sales efforts by monitoring market developments and performing comprehensive analysis of proposed/existing regulations and legislation; includes identifying, quantifying and communicating the impact of potential policy changes.
Associate Director, HCP Marketing Strategy - Neuromuscular Disease NovartisAssociate Director, HCP Marketing Strategy - Neuromuscular DiseaseEast Hanover, MassachusettsPartnering across Commercial, Medical Affairs, Customer Engagement, Market Access, Insights & Analytics, and Global teams, you will translate customer and market insights into impactful educational, engagement, and omnichannel strategies that prepare the market for launch, strengthen healthcare professional engagement, and support improved patient identification and care. Partner with Medical Affairs, Field Medical, Customer Engagement, Sales, Market Access, Insights & Analytics, Legal, Regulatory, Compliance, Global, Communications, and agency partners to ensure aligned strategy, compliant execution, and coordinated market preparation.
Associate Director, Patient Marketing Strategy - Neuromuscular Disease NovartisAssociate Director, Patient Marketing Strategy - Neuromuscular DiseaseEast HanoverWorking across Patient Services, Advocacy, Market Access, Medical Affairs, Customer Experience, and agency partners, you will play a key role in strengthening connections with the FSHD community, supporting treatment readiness, and building the capabilities and engagement infrastructure needed to support a successful launch and ongoing patient engagement. As the Associate Director, Patient Marketing Strategy, you will develop and execute patient-focused marketing initiatives that support disease awareness, engagement, and launch readiness, helping translate patient, caregiver, and advocacy insights into meaningful educational and marketing programs.
Veeva RIM Specialist ImmunityBioVeeva RIM SpecialistSummit, 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.