Director, Biostatistics SyndaxDirector, BiostatisticsNew York, NY$235,000–$260,000 / yearThe Role: This role provides expertise and guidance in collaboration with cross-functional groups broadly across the organization in establishing study design and analyses in addition to strategy, and institutes best practices with regards to planning, execution, interpretation and regulatory submission of clinical projects and studies. Base pay is just one element of our package and is determined within a range based on several factors including market data, experience, qualifications, demonstrated skills, relevant education or training, travel requirements and internal equity.
Director, Omnichannel - Global Oncology Medical Affairs Daiichi Sankyo, Inc.Director, Omnichannel - Global Oncology Medical AffairsBasking Ridge, NJ$189,600–$284,400 / yearFull timeDemonstrated experience in content management strategy including digitalizing and modularizing medical content; Proven leadership skills in a cross-functional global team environment; Experience in managing cross-functional teams, collaborating with diverse stakeholders and with the ability to influence without authority; Strong knowledge of industry best practices; Strong understanding of regulatory requirements and compliance considerations in the pharmaceutical industry; Excellent leadership and communication skills, with the ability to partner and work with teams across regions and functions required. Cross-team Collaboration: Work with a cross-functional medical affairs team including Franchise and GMAT leads, Region (Medical, Omnichannel, and Analytics) leads, Affiliate Medical Directors, Content Team, Scientific Engagement Team, Analytics and Data Teams to enable medical engagement strategy (i.e. medical journeys with associated outcomes) and enable capability pull-through.
Head, Global Oncology Medical Affairs, Clinical Trial Management, Resources, Operations & Governance Daiichi Sankyo, Inc.Head, Global Oncology Medical Affairs, Clinical Trial Management, Resources, Operations & GovernanceBasking Ridge, NJ$271,500–$452,500 / yearFull timeEnsure all key internal stakeholders are aligned on the approach and the conduct of a global studies/programs that will be implemented in multi-regions (US, Europe, ASCA, Japan)- including Regional Medical, Regional Operations, Safety, Regulatory, Quality, Legal/Compliance, Clinical Supply Operations, Global Program Teams, GMAT Leads, GMA leadership. Responsible for primary data evidence generation delivery of GMA programs: Company Initiated studies (CIS), Non-Interventional Studies (NIS) and Expanded Access Programs (EAP) delivery across countries in Oncology Business Unit and other Regions.
Senior Project Manager, CMC Operations Medexus Pharmaceuticals IncSenior Project Manager, CMC OperationsNY$140,000–$180,000 / yearThe Senior Project Manager sets clear plans and priorities, drives accountability, manages risks and decisions, and builds strong working relationships across Technical Operations, Quality, Regulatory Affairs, Supply Chain, Finance, Commercial, and external partners. The Senior Project Manager, CMC Operations leads cross-functional CMC and manufacturing projects that support commercial supply, product lifecycle management, and technical operations across Medexus Pharma.
Deputy General Counsel SiriusPointDeputy General CounselNew York City, New York$325,000–$350,000 / yearThis executive will act as a trusted advisor to the Chief Legal Officer, the Executive Leadership Team and members of senior management on a wide range of matters, including securities law compliance, public company reporting obligations, mergers and acquisitions, capital raising activities, investment, treasury and financing transactions, shareholder matters, strategic investments, and significant commercial arrangements. The Deputy General Counsel serves as a senior member of the Legal, Regulatory & Compliance leadership team and is responsible for leading the company's capital markets, strategic transactions, corporate legal affairs, corporate secretary and legal operations.
Associate Director, Consumer US Marketing Daiichi Sankyo, Inc.Associate Director, Consumer US MarketingBasking Ridge, NJ$162,400–$243,600 / yearFull timeWith a legacy of innovation since 1899, a presence in more than 30 countries, and more than 19,000 employees, we are advancing breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders. Guided by our 2030 vision to "be an innovative global healthcare company contributing to the sustainable development of society", we are shaping a healthier, more hopeful future for patients, their families, and society.
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).
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.
Sales Training Senior Manager/Director Aquestive Therapeutics Inc.Sales Training Senior Manager/DirectorWarren, NJAs a key member of the commercial organization, this individual will be responsible for building a comprehensive learning curriculum that equips sales leaders and specialty sales representatives with the knowledge, skills, and behaviors necessary for launch success and growth. The Director will partner closely with Sales, Marketing, Medical Affairs, Market Access, Legal, Regulatory, Compliance, and external partners to translate commercial strategy into effective, compliant, and measurable learning experiences.
Senior Manager, Regulatory Affairs, Advertising & Promotion Regeneron PharmaceuticalsSenior Manager, Regulatory Affairs, Advertising & PromotionSleepy Hollow, NY$150,500–$245,500 / yearHelp lead and assist in all interactions with the FDA Office of Prescription drug Promotion (OPDP) for assigned company products, responsible for helping to maintain working relationship and effective communication with FDA OPDP reviewers with respect to advertising and promotion matters, including request for advisory submissions. Provide timely regulatory advice and guidance, with minimal guidance from Regulatory Affairs, Advertising & Promotion Director, to Commercial teams and Medical Affairs with respect to conference exhibit activities, disease awareness and speaker programs.
Associate Manager, Regulatory Affairs Strategy - Oncology Regeneron Pharmaceuticals IncAssociate Manager, Regulatory Affairs Strategy - OncologyTarrytown, NY$109,900–$179,300 / yearDiscover your role: Coordinating the preparation, submission, management and maintenance of global regulatory submissions related to clinical and nonclinical aspects of product development in oncology therapeutic area, including, but not limited to, the following: INDs/CTAs, amendments and information requests, Orphan drug applications, Annual Reports and Investigator's Brochure. The Associate Manager, Regulatory Affairs will report to the Global Regulatory Liaison (GRL) and provides support to the GRL in all aspects of regulatory affairs related to the development of novel therapeutics including quality, preclinical and clinical areas of drug development and the policies/procedures required to ensure compliance with regulations.
Manager, Policy and Regulatory Affairs EnergyHubManager, Policy and Regulatory AffairsNew York, NY$115,000–$130,000 / yearWe collect and use those categories of Personal Information about you for human resources and other business management purposes, including identifying and evaluating you as a candidate for potential or future employment or future positions, recordkeeping in relation to recruiting and hiring, conducting analytics, and ensuring compliance with applicable legal requirements and Company policies. Work with the latest technologies: You'll gain exposure to a broad spectrum of IoT, SaaS and machine learning obstacles, including distributed fault-tolerance, device control optimization, and process modeling to support scalable interaction with disparate downstream APIs.
Legal Counsel Of Corporate And Regulatory Affairs Atlantic Health SystemLegal Counsel Of Corporate And Regulatory AffairsMorristown, NJDraft, review, negotiate, and interpret a broad range of commercial agreements, including professional services agreements, physician and provider arrangements, purchasing and supply chain contracts, consulting agreements, confidentiality agreements, technology and software agreements, revenue-generating partnerships, and other operational contracts. As a member of a collaborative in-house legal department, Counsel will work closely with executive leadership, clinical and operational teams, compliance professionals, and business partners to develop practical legal solutions that advance innovation while ensuring regulatory compliance and protecting the organization's mission.
Legal Counsel of Corporate and Regulatory Affairs Atlantic Health System IncLegal Counsel of Corporate and Regulatory AffairsMorristown, NJDraft, review, negotiate, and interpret a broad range of commercial agreements, including professional services agreements, physician and provider arrangements, purchasing and supply chain contracts, consulting agreements, confidentiality agreements, technology and software agreements, revenue-generating partnerships, and other operational contracts. As a member of a collaborative in-house legal department, Counsel will work closely with executive leadership, clinical and operational teams, compliance professionals, and business partners to develop practical legal solutions that advance innovation while ensuring regulatory compliance and protecting the organization''s mission.
Global Regulatory Affairs (GRA) Fellow BeOne Medicines AGGlobal Regulatory Affairs (GRA) FellowNYGeneral Description: The BeOne Medicines Global Regulatory Affairs (GRA) Fellow will engage in a one-year rotational program that includes working in various departments within GRA to support BeOne regulatory drug development in Global Regulatory Policy and Intelligence (GRPI), Regulatory Strategy, Advertising and Promotion, and Labeling. Essential Functions of the job: The GRA Fellow will rotate throughout the Global Regulatory Affairs Department in the four below sub-departments and perform the tasks identified below under the supervision of each respective sub-department: Global Regulatory Policy and Intelligence (GRPI).
Senior Principal Scientist, Clinical Research, Thoracic Malignancies Merck & Co IncSenior Principal Scientist, Clinical Research, Thoracic MalignanciesRahway, NJ$282,200–$444,200 / yearMonitoring 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. Assist the Senior/Executive Director in ensuring that appropriate corporate personnel are informed of the progress of studies of our Company's and competitors' drugs and internal and external expert opinion on scientific questions relevant to his/her areas of responsibility.
Principal Scientist, Translational Medicine, Neuroscience Merck & Co IncPrincipal Scientist, Translational Medicine, NeuroscienceRahway, NJ$255,800–$402,700 / yearPrimary responsibilities for the Principal Scientist include the following: Working with basic science teams on specific diseases and therapeutic areas, providing clinical expertise for identification and validation of novel targets, including the design of preclinical and clinical experiments to validate targets and/or pathways, and leveraging this work for development of novel therapeutics. Translational Medicine is specifically responsible for: Contributing to the identification of novel targets by partnering with Discovery Sciences to bring a clinical perspective into the earliest stages of target identification and validation, and to execute clinical studies to evaluate the relevance of potential targets to human disease in order to justify full development.
Director US Advertising and Promotion Global Regulatory Affairs SanofiDirector US Advertising and Promotion Global Regulatory AffairsMorristown, NJ$178,500–$257,833.33 / yearThe Director is responsible for decision-making, direction, and oversight of the day-to-day activities of their assigned products, departmental activities, and direct reports (if applicable) in order to meet internal and external customer needs. About the job: As the Director, US Advertising and Promotion, Global Regulatory Affairs within our GRA Advertising and Promo Team, you will be responsible for decisions, providing strategic direction and oversight for the day-to-day activities for assigned products.
Director US Advertising And Promotion Global Regulatory Affairs SanofiDirector US Advertising And Promotion Global Regulatory AffairsMorristown, NJ$178,500–$257,833.33 / yearThe Director is responsible for decision-making, direction, and oversight of the day-to-day activities of their assigned products, departmental activities, and direct reports (if applicable) in order to meet internal and external customer needs. About the job: As the Director, US Advertising and Promotion, Global Regulatory Affairs within our GRA Advertising and Promo Team, you will be responsible for decisions, providing strategic direction and oversight for the day-to-day activities for assigned products.
Clinical Director, Oncology Early Development Merck & Co IncClinical Director, Oncology Early DevelopmentRahway, NJ$255,800–$402,700 / yearThe 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. The Clinical Director (Principal Scientist) has primary responsibility for planning and directing clinical research activities involving new or marketed medicines in the Early Oncology therapeutic area.