NewAssociate Principal Scientist, Global Regulatory Lead Organon & CoAssociate Principal Scientist, Global Regulatory LeadFlorham Park, NJ$125,400–$213,100 / yearRepresent our company with external organizations through direct communication with the FDA, EMA, or other EU regulatory agencies, including telephone calls and e-mail; chair meetings between company and FDA or EMA; prepare our company's teams for meetings with FDA or EMA at any phase of drug development. Associate Principal Scientist, Global Regulatory Lead reporting to the Executive Director, Fertility Lead will be responsible for the development and implementation of world-wide regulatory strategies, including CMC elements, for the medical devices and combination products (MDCP) portfolio.
Sr. Software Engineer (Operational Systems Team) CleerlySr. Software Engineer (Operational Systems Team)New York, NY$153,000–$179,000 / yearCandidates located in higher-cost labor markets , including California, Washington, New York, New Jersey, Connecticut, Massachusetts, and Washington, DC represent the middle to high end of the range, while candidates located in all other U.S. locations represent the low to middle end of the range. *Total Target Compensation (TTC): Total Cash Compensation (including base pay, variable pay, commission, bonuses, etc.) Additionally, stock options, paid benefits, and employee perks are part of your total rewards.
Executive Director, Clinical Science, Ophthalmology & Neuroscience Merck & Co IncExecutive Director, Clinical Science, Ophthalmology & NeuroscienceRahway, NJ$255,800–$402,700 / yearRequired Skills: Advanced Analytics, Artificial Intelligence (AI), Clinical Development, Clinical Sciences, Cross-Functional Leadership, Drug Development, Executive Leadership, Global Clinical Studies, Innovation, Matrix Leadership, Neuroscience, Ophthalmology, Regulatory Submissions, Strategic Leadership, Talent Development. Partner withthe Ophthalmology and Neuroscience Therapeutic Area Heads and leaders across Clinical Operations, Regulatory Affairs, Biostatistics and Data Management, Drug Safety and Pharmacovigilance, Translational Medicine, and Medical Affairs to drive development strategy execution and delivery of key portfolio milestones.
Director, Global Medical Affairs, Omnichannel Transformation & Customer Experience BeOne Medicines AGDirector, Global Medical Affairs, Omnichannel Transformation & Customer ExperienceNY$192,100–$252,100 / yearThe Director, GMA Omnichannel Innovation & Customer Experience will help lead this evolution by translating medical strategy, customer insights, scientific priorities, and key messages into clear engagement plans that connect content, channels, timing, field interactions, and measurement into coordinated and data driven customer journeys. Computer Skills: Strong proficiency in Microsoft 365 and omnichannel engagement platforms, CRM, NBA, analytics dashboards, CMS/DAM systems, Medical/Legal/Regulatory review platforms, HCP insights platforms, Veeva/Vault Medical, third-party media platforms, Generative AI and AI-enabled engagement and content capabilities.
Associate Director, KOL Engagement Achondroplasia BridgeBio Pharma IncAssociate Director, KOL Engagement AchondroplasiaNY$175,900–$222,000 / yearPartner closely with internal teams to ensure we are using appropriate insights and metrics to inform the KOL management strategy and activities - directly to KOLs and with KOLs toward community physicians. Success will be measured by gaining and sharing of key insights, and the development of knowledge related to an asset and/or disease state and well as the development of mutually beneficial partnerships with relevant stakeholders.
Manager, Legal Affairs Tapestry, Inc.Manager, Legal AffairsNew York, NY$80,000–$95,000 / yearCourage: Doesn't hold back anything that needs to be said; provides current, direct, complete, and "actionable" positive and corrective feedback to others; lets people know where they stand; faces up to people problems on any person or situation (not including direct reports) quickly and directly; is not afraid to take negative action when necessary. Building Effective Teams: Blends people into teams when needed; creates strong morale and spirit in their team; shares wins and successes; fosters open dialogue; lets people finish and be responsible for their work; defines success in terms of the whole team; creates a feeling of belonging in the team.
Executive Director, Clinical Science, Oncology, Genitourinary, Melanoma, and Women's Cancers Merck & Co IncExecutive Director, Clinical Science, Oncology, Genitourinary, Melanoma, and Women's CancersRahway, NJ$255,800–$402,700 / yearRequired Skills: Advanced Analytics, Artificial Intelligence (AI), Clinical Development, Clinical Sciences, Cross-Functional Leadership, Executive Leadership, Global Clinical Studies, Innovation, Matrix Leadership, Oncology, Oncology Drug Development, Regulatory Submissions, Strategic Leadership, Talent Development. The Executive Director, Clinical Science is a senior leader within Oncology Clinical Development responsible for providing strategic, scientific, operational, and people leadership across a portfolio of oncology programs spanning multiple therapeutic areas (Genitourinary, Melanoma, and Women's Cancers) and stages of development.
Executive Director, Clinical Science, Cardiometabolic Merck & Co IncExecutive Director, Clinical Science, CardiometabolicRahway, NJ$255,800–$402,700 / yearRequired Skills: Advanced Analytics, Artificial Intelligence (AI), Cardiometabolic, Cardiovascular Medicine, Clinical Development, Clinical Sciences, Cross-Functional Leadership, Drug Development, Executive Leadership, Global Clinical Studies, Innovation, Matrix Leadership, Regulatory Submissions, Strategic Leadership, Talent Development. The Executive Director, Clinical Science is a senior leader within Non-Oncology Clinical Development responsible for providing strategic, scientific, operational, and people leadership across a portfolio of cardiometabolic programs including cardiovascular, respiratory, metabolism and atherosclerosis, and spanning multiple stages of development.
Medical Science Liaison - Transplant / Infectious Diseases (Great Plains region) Veloxis Pharmaceuticals, IncMedical Science Liaison - Transplant / Infectious Diseases (Great Plains region)New York, New York$170,000–$207,000Identifies and conducts outreach to key HCPs within the assigned territory to build and strengthen relationships and represent the Company's interests, including those in national and regional healthcare systems, integrated delivery systems, payors, and group purchasing organizations in the areas of medical education, clinical, non-clinical and health economics and outcomes research. The Medical Science Liaison contributes to the Company's success by utilizing scientific exchange and interpersonal skills to develop relationships with healthcare practitioners (HCPs), including key opinion leaders, seeking to optimize patient outcome through proper understanding of the disease state, appropriate patient identification and appropriate utilization of the Company's product.
Director, IVD Regulatory Consulting Precision Medicine Group LLCDirector, IVD Regulatory ConsultingNY$162,000–$243,000 / yearPosition Summary: The Director, CDx Regulatory Consultant will be responsible for applying deep expertise in companion diagnostic regulatory strategy, IVD development, quality system expectations, and global marketing authorization pathways to advise pharmaceutical, biotechnology, and diagnostic clients on the development, clinical trial use, approval, and lifecycle management of companion diagnostics. Direct the preparation of global regulatory submissions and supporting documentation for companion diagnostics and clinical trial assays, including FDA Q-Submissions, Pre-IDE packages, IDEs, PMAs, PMA supplements, EU IVDR Annex XIV performance study applications, technical documentation, and other country-specific submissions.
NewDirector, Corporate Affairs Strategy, Analytics & Insights BeOne Medicines AGDirector, Corporate Affairs Strategy, Analytics & InsightsNY$169,000–$229,000 / yearThe role partners closely with the Head of Global Corporate Affairs Strategy, Analytics & Insights to translate strategy into execution, drive organizational alignment, strengthen decision-making through data and insights, and build scalable capabilities that increase the impact and effectiveness of Corporate Affairs. General Description: BeOne Medicines is seeking an accomplished and forward-thinking Director of Corporate Affairs Strategy, Analytics & Insights to help drive the evolution of a high-performing, insight-led global Corporate Affairs function.
Director, Nonclinical Development Organon & CoDirector, Nonclinical DevelopmentFlorham Park, NJ$152,300–$259,200 / yearSupport Regulatory activities for global products such as, annual reporting of nonclinical activities and literature, support new regional drug applications, regional license renewals, author responses to questions from global Heath Authorities. This position will report to the Executive Director, Translational Sciences and Nonclinical Development and work collaboratively with early clinical development, late-clinical development, regulatory affairs, safety and pharmacovigilance, chemistry, manufacturing and control (CMC), medical affairs and business development as necessary.
NewSenior Director, Global Regulatory Affairs - Biotech Unit BeOne Medicines AGSenior Director, Global Regulatory Affairs - Biotech UnitNY$211,200–$281,200 / yearEssential Functions of the Job: Accountable for providing high level strategic and operational regulatory direction and mentorship on projects including, but not limited to general regulatory strategies, regulatory requirements for clinical studies and marketing approval in multiple countries, regulatory strategic development plans and risk assessments, critical issue management and advice on Health Authority interactions. Leveraging deep therapeutic and functional area expertise, the Regulatory Affairs Lead is accountable for developing, implementing, and advising on global regulatory strategies for development programs to secure and maintain market access for products in line with the partnership program's goals, and in coordination with key Advisory Committee and Execution Unit.
Clinical Research Associate (CRA) - Immunology-Remote Merck & Co IncClinical Research Associate (CRA) - Immunology-RemoteRahway, NJRemote$96,200–$151,400 / yearRequired Skills: Adverse Event Reporting System, Clinical Research Methods, Clinical Site Management, Clinical Study Management, Clinical Trial Planning, Clinical Trials, Clinical Trials Monitoring, Core Competencies, Early Clinical Development, Policy Development, Preventive Action, Protocol Adherence, Regulatory Affairs Compliance, Regulatory Compliance, Site Management, Training Team Members. Conducts site visits including but not limited to validation visits, initiation visits, monitoring visits, close-out visits and records clear, comprehensive and accurate visit & non-visit contact reports appropriately in a timely manner.
Clinical Research Associate (CRA) - Cardiovascular (Remote) Merck & Co IncClinical Research Associate (CRA) - Cardiovascular (Remote)Rahway, NJ$96,200–$151,400 / yearConducts site visits including but not limited to validation visits, initiation visits, monitoring visits, close-out visits and records clear, comprehensive and accurate visit & non-visit contact reports appropriately in a timely manner. Works in partnership with GCTO country operations, finance, regulatory affairs, pharmacovigilance, legal and regional operations, HQ functional areas and externally with vendors and IRB/IECs and Regulatory Authorities in support of assigned sites.
Director, Commercial Data & Digital Solutions Teva Pharmaceutical Industries LtdDirector, Commercial Data & Digital SolutionsParsippany, NJ$161,000–$202,000 / yearThis role partners closely with Marketing, Sales, Commercial Operations, Patient Services, Medical Affairs, Market Access, and external partners to create scalable, compliant, and insight driven solutions that accelerate brand performance and customer engagement. The IT Director, Commercial Data & Digital Solutions will lead the strategy, delivery, and continuous evolution of data, analytics, and digital capabilities that power Commercial excellence across innovative pharmaceutical brands.
Associate Director, Regulatory Affairs - CMC PTC TherapeuticsAssociate Director, Regulatory Affairs - CMCWarren, NJ$169,100–$212,800 / yearLeads global post-approval CMC regulatory strategy for commercial products, providing CMC regulatory leadership for lifecycle changes (e.g., manufacturing site changes, scale-up/tech transfer, process improvements, control strategy updates, and analytical method changes) to ensure supply continuity and align data packages to regional requirements. Works with CMC Writing, Regulatory Operations, and Submission Project management to support development of internal processes to improve the CMC aspects in regulatory documents, including the writing, review, and approval process, critical review and reconciliation of team comments, and ensuring documents are of high-quality.
Distinguished Scientist, Companion Diagnostics Merck & Co IncDistinguished Scientist, Companion DiagnosticsRahway, NJ$210,400–$331,100 / yearThe Distinguished Scientist/ Executive Director within Companion Diagnostics (CDx) Development, will lead one of our company's Diagnostic Development Teams (DxDTs), supervising PhD-/MD-level employees, developing and overseeing CDx strategy development, alignment and execution for specific projects, including associated digital pathology (DP) projects when applicable. Primary Responsibilities: Lead cross-functional DxDT including Regulatory, Commercial, Business Development, Project Management, Operations, Clinical Development, Statistics, Bioinformatics, etc. to drive CDx strategy, development and implementation of CDx projects - and associated DP when relevant - for a portfolio of various assets/biomarkers, mainly in the therapeutic area of Oncology.
Regulatory Compliance Manager Sterling Engineering, Inc.Regulatory Compliance ManagerLodi, NJ$120,000–$140,000 / yearThis individual will lead compliance initiatives related to domestic and international regulations, sustainability, environmental reporting, and product compliance while partnering with cross-functional teams to support new product development and business growth. A growing manufacturing organization is seeking an experienced Regulatory Compliance Manager to oversee regulatory programs across a diverse product portfolio.
Head of Medical Information Bristol-Myers Squibb CoHead of Medical InformationNY$210,572–$255,164 / yearThe team member will serve as a subject matter expert for internal and external audiences, act as the primary liaison to Bristol Myers Squibb's (BMS) Medical Information organization to ensure alignment of processes, systems, and shared services, and contribute to cross-functional Medical Affairs initiatives supporting RayzeBio's radiopharmaceutical portfolio. Based on eligibility*, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day.