Associate Director, Regulatory Affairs Advertising and Promotion Daiichi Sankyo, Inc.Associate Director, Regulatory Affairs Advertising and PromotionBasking Ridge, NJ$166,720–$250,080 / yearFull timeThe Associate Director, Regulatory Affairs Advertising and Promotion (RAAP) provides strategic and tactical regulatory support for U.S. promotional and selected non-promotional communications across assigned products, disease-state initiatives, and related external-facing materials within the Daiichi Sankyo portfolio. Partner with Medical, Legal, Compliance, Commercial, Clinical, Labeling, Public Affairs, Corporate Communications, Market Access, including alliance partners to support aligned, efficient, and compliant review of promotional materials.
Executive Director, Head of Clinical Supply Planning and Operations SCM Daiichi Sankyo, Inc.Executive Director, Head of Clinical Supply Planning and Operations SCMBasking Ridge, NJ$255,000–$425,000 / yearFull timeAdditionally, as the regional head of DSI (US) CSO, this position will 1) Oversee all the Clinical Supply Operation-related functions in DSI, 2) Ensure alignment between DSI-CSO and TECH Unit sub-functions (Project Lead (CMC), Regulatory Affairs CMC, Process Technology Research, Formulation Technology Research, and Analytical & Quality Evaluation Research), 3) Make the best effort to increase the total performance of the TECH Unit. Responsible for leading all Clinical Supply Operation (CSO)-related activities for oncology and specialty medicine drug candidates from early development to launch and life cycle management of products globally to achieve the business success of Daiichi Sankyo Group and managing the Global-CSO function from Daiichi Sankyo Inc. (DSI).
Manager, Global Vendor Quality, Global R&D & PV QA Daiichi Sankyo, Inc.Manager, Global Vendor Quality, Global R&D & PV QABasking Ridge, NJ$127,280–$190,920 / yearFull timeThis position focuses on operational execution, oversight, and continuous improvement of vendor quality activities, contributing subject-matter expertise while working under the direction of senior vendor quality leadership. The Manager, Global Vendor Quality (Global R&D & PV QA) supports the development, implementation, and execution of the GCP/GLP/GVP vendor quality program across Daiichi Sankyo group companies.
Head of Quality Assurance, Drug Product, GMP QA Daiichi Sankyo, Inc.Head of Quality Assurance, Drug Product, GMP QABasking Ridge, NJ$226,275–$377,125 / yearFull timeAs a member of SLT/SMT, the role will provide oversight of manufacturing sites according to the product lifecycle, collaborate with Quality teams to complete PPQ planning and the transition to commercial manufacturing activities for the product portfolio, and provide technical expertise to their team of MSMQs. Resolve issues in internal and external manufacturing site quality performance escalated from MSMQs in collaboration and negotiation with Tech Unit Senior Leaders (L-2 Leaders) and other internal peer groups, and escalate issues to GMQ Head as necessary for resolution and approval.
Director, PV QA DSI Daiichi Sankyo, Inc.Director, PV QA DSIBasking Ridge, NJ$184,240–$276,360 / yearFull timeThe role will participate in other PV QA projects, tasks, and initiatives as needed and as instructed, including but not limited to including planning and PV QA executing the Pharmacovigilance Quality Strategy Plan in alignment with the DSI business objectives, review of key REMS documents, Health Authority Commitments, Quality Event management, escalation process and the CAPA oversight across applicable functional areas. Lead the PV inspection management activities by ensuring readiness, compliance, and inspection preparedness for the respective regulatory inspections in alignment with regulatory and company strategy, including coordinating and supporting preparation of CSPV teams and active participation and management of these processes, specifically in the US.
Senior Director, Clinical Safety Scientist Daiichi Sankyo, Inc.Senior Director, Clinical Safety ScientistBasking Ridge, NJ$242,700–$404,500 / yearFull timeLead scientist team to collaborate with safety physicians, regulatory affairs, clinical development, other functions and external partners to deliver high-quality safety assessments, regulatory submissions, aggregate reports, and responses to health authority queries. In addition to operational oversight, this role contributes to the development of global safety processes, talent capability building, and strategic alignment across the broader Clinical Safety and Pharmacovigilance (CSPV) function and the enterprise.
Associate Director, External Supplier QA GMP Daiichi Sankyo, Inc.Associate Director, External Supplier QA GMPBasking Ridge, NJ$153,600–$230,400 / yearFull timeCross-Functional Team Participation: Responsible for working with Quality Leaders in each operating site to influence and affect the necessary operations managed through the leadership teams and will partner closely with other Subject Matters Expert across all the Functional Units (Global ADC Team Members, Pharmaceutical Technology, QA-GMP and QA R&D functional areas, Regulatory Affairs – CMC, Pharmacovigilance, Medical Affairs and Supply Chain) to ensure compliant operations. Quality Management System (QMS): Ensures and support that a robust QMS is in place at CMOs with respect to the facility, equipment & lab instruments, engineering, maintenance, computerized systems and validation activities which complies with GMP guidelines such as ICH and PIC/s as well as FDA regulation requirements, industry best practices and will withstand regulatory inspections by regulatory authorities and regular audits.
Executive Director, Global Clinical Lead Daiichi Sankyo, Inc.Executive Director, Global Clinical LeadBasking Ridge, NJ$329,025–$548,375 / yearFull timeProvides senior level clinical representation at meetings with health authorities; Leads the creation of developmental and regulatory strategy; Accountable for performance of CROs; Routine interactions with senior management of CRO/ARO, as needed; Accountable for clinical development plans, protocol profiles and sections of key submission documents; Represents Clinical Development as team leader or as supervisor of team leaders; Accountable for Clinical Development input into commercial strategy including Translational Medicine and biomarker strategy; Thought partner in driving Business Development decisions in collaboration with External Scientific Affairs dept. Study planning and execution: Develops prospective contingency plans for management of key risks across a large project or a portfolio of projects or across the Therapeutic Area; Clearly defines priorities and high level execution plans across projects within and outside of Daiichi Sankyo; Supports effective communication and decision-making process cross-functionally and cross-regionally at department level.
NewSenior Marketing Manager TeneoSenior Marketing ManagerNew York, NY$170,000–$180,000 / yearOur full range of advisory services includes strategic communications, investor relations, financial transactions and restructuring, management consulting, physical and cyber risk, organizational design, board and executive search, geopolitics and government affairs, corporate governance and ESG. Base Salary Range: $170,000-180,000 (Compensation for this role will depend on several factors, including a candidates qualifications, skills, competencies, and experience that may fall outside of the range listed.).
NewTravel RN - Telemetry - $2,124 per week HonorVet TechnologiesTravel RN - Telemetry - $2,124 per weekNew York, NYRole models the tenets of Mount Sinai Relationship Centered Care (MSHRCC) through facilitation of the following actions including, but not limited to, Admission Welcome, Bedside shift Report, HELP (High Risk Medications, Equipment, Lines/Drains/Airway, Pain and Plan of Care) AM/PM Care, 5 Minute Sit Down, Purposeful Hourly Rounding, Medication Review, Discharge Wrap Up, and MD/RN Unit Collaboration. As a Joint Commission-certified clinical staffing agency , we deliver unmatched expertise in placing top-tier healthcare professionals—RNs, LPNs/LVNs, CNAs/CMAs, and NPs—across diverse facilities, including hospitals, clinics, rehabilitation centers, old-age homes, schools, correctional facilities, and more.
NewChief Financial Officer - IPO IPO Kforce Inc.Chief Financial Officer - IPO IPONew York, NYRemote$300,000–$373,750Demonstrated government and regulatory experience, such as engaging with government agencies, navigating public policy, securing incentives/grants, or managing relations with regulatory bodies (e.g., experience in sectors with heavy government oversight like infrastructure, defense, energy, or regulated industries). Experience leading/contributing to an IPO process, including f S-1 filings, SEC compliance, roadshows, and transition to public company reporting (prior successful IPO as CFO highly preferred; Experience in pre-IPO readiness or public company finance acceptable).
Scientific Director Senior Medical Director Multiple Myeloma International Medical Affairs AbbVie IncScientific Director Senior Medical Director Multiple Myeloma International Medical AffairsFlorham Park, NJThe Scientific Director / Senior Medical Director provides specialist medical and scientific input into core strategic and operational medical affairs activities such as: health-care professional and provider interactions; generation of clinical and scientific data (enhancing therapeutic benefit and value); educational initiatives (medical education, scientific communications, and value proposition) and safeguarding patient safety (risk minimization activities and safety surveillance activities). Acts as a clinical interface and actively solicits opinion through leader interactions related to the molecule and disease area; partners with Medical Affairs, Commercial and other functions in these activities as required, consistent with corporate policies, to ensure that broad cross-functional perspectives are incorporated into Clinical Development Plans and protocols as appropriate.
Program Manager, Fellowship Affairs Council on Foreign RelationsProgram Manager, Fellowship AffairsNew York, New York$78,000–$87,000 / yearTo that end, CFR is dedicated to continuing to advance diversity, equity, and inclusion throughout its work and workplace by building a more diverse membership and staff, producing and dispensing thoughtful analysis on a broad range of foreign policy issues, and developing relevant, wide-reaching programming that also serves to expand the foreign policy talent pipeline to underrepresented populations. About CFR: The Council on Foreign Relations (CFR) is committed to fostering a foreign policy community in the United States that is more representative of American society, recognizing that diverse backgrounds and perspectives contribute to broader, more informed participation in the foreign policy debate and lead to an enhanced understanding of the world and the United States’ role therein.
New["Regulatory Affairs Mfg Consultant","Regulatory Affairs Mfg Consultant"] Millenniumsoft["Regulatory Affairs Mfg Consultant","Regulatory Affairs Mfg Consultant"]Franklin LakesRequires the analysis of data, problem solving analysis, in depth evaluations of various factors and project management. This position is responsible for the preparation of International regulatory submissions required to market new or modified medical devices in Outside of the US (OUS).
Senior Director Regulatory Affairs Liaison- General Medicine Merck & Co IncSenior Director Regulatory Affairs Liaison- General MedicineRahway, NJ$190,800–$300,300 / yearRequired Skills: Corporate Commercial, Cross-Cultural Awareness, Drug Development, Exercises Judgment, Global Health, Global Market, Healthcare Innovation, Interpersonal Relationships, In Vitro Diagnostics (IVD), Multiple Therapeutic Areas, Oral Communications, Orphan Drugs, Pharmaceutical Regulatory Affairs, Process Improvements, Regulatory Affairs Compliance, Regulatory Affairs Management, Regulatory Communications, Regulatory Compliance, Regulatory Issues, Regulatory Management, Regulatory Strategy Development, Written Communication. As the Global Regulatory Lead (GRL), the Senior Principal Scientist functions as the regulatory single, accountable, global point of contact on the project team and interacts with the global regulatory agencies and/or subsidiaries with regard to global regulatory strategy/registration requirements for one or more company investigational and marketed drugs/biologics in early- and/or late-stage development.
Program Coordinator, Student Affairs Columbia UniversityProgram Coordinator, Student AffairsNew York, NY$67,300–$75,000 / yearCreate and monitor the application platform in the spring semester to ensure program policies and timelines are in accordance with University rules and regulations; collect application materials submitted by students and respond to student questions throughout the application process; collate application materials and submit to MARSEA Directors for review; convene and participate in meetings with directors to select students and determine financial aid offers; notify students of application status; process applications according to University rules. In support of the Directors of the Institute's Master of Arts in Regional Studies-East Asia (MARSEA) program, the incumbent will manage the administration of the Institute's graduate program, including (30%): Coordinate with various University student services offices as needed to ensure that optimal programs, courses, and support services are available for WEAI students.
NewRegulatory Affairs/Quality Affairs Specialist ElliquenceRegulatory Affairs/Quality Affairs SpecialistBALDWIN, NYFull timeCreate documentation in response to customer regulatory requests which includes regulatory letters, authorization letters, certifications, attestations, technical packages, etc. for tenders and for pre-market clearance. This role collaborates cross-functionally across the organization to prepare, submit, and maintain regulatory filings with agencies such as the U.S. FDA, European Notified Bodies, and other international authorities.
Director, Regulatory Affairs Liaison, Vaccines & Infectious Diseases Merck & Co IncDirector, Regulatory Affairs Liaison, Vaccines & Infectious DiseasesRahway, NJ$210,400–$331,100 / yearRequired Skills: Biological Sciences, Biostatistics, Clinical Judgment, Clinical Trial Planning, Clinical Trials, Communication, Cross-Functional Collaboration, Detail-Oriented, Infectious Disease, Leadership, Medical Writing, Pharmaceutical Regulatory Affairs, Pharmacovigilance, Regulatory Affairs Compliance, Regulatory Affairs Management, Regulatory Intelligence, Regulatory Issues, Regulatory Strategy Development, Regulatory Writing. Primary activities include, but are not limited to: Functions with a high degree of independence and provides regulatory oversight for assigned products, functioning as the single, accountable, global regulatory point of contact on those projects within Global Regulatory Affairs and Clinical Safety (GRACS) and external to GRACS.
New York Director, Government Affairs Natural Resources Defense CouncilNew York Director, Government AffairsNew York, NY$150,000–$170,000 / yearNRDC combines the power of more than 3 million members and online activists with the expertise of some 800 policy advocates, lawyers, scientists, and communication experts to confront the climate crisis, protect nature, ensure the rights of all people to clean air, clean water, and healthy communities. Our team works across the United States and around the world, from offices in Chicago, Denver, Los Angeles, New York City, San Francisco, and Washington, D.C., as well as in Beijing, London, and New Delhi (a subsidiary of NRDC India Pvt.
Associate Director, US Government Affairs Genscript Biotech CorpAssociate Director, US Government AffairsPiscataway, NJ$150,000–$160,000 / yearLeverage learnings with key elected officials to update message points to ensure GenScript and ProBio can (1) describe succinctly what we do, (2) the impact we have in the biotech ecosystem, (3) respond to any concerns raised, or anticipated to be raised, by elected officials, and (4) prepare what we need from each elected official in anticipation of being asked this question from an elected official. Founded in 2002 in New Jersey, GenScript Biotech Corporation accelerates innovation in biotech and healthcare by providing researchers and companies with the building blocks needed to develop groundbreaking treatments and products.