- Jazz Pharmaceuticals (San Jose, CA)
- …Jazz employee please apply via the Internal Career site. Jazz Pharmaceuticals is a global biopharma company whose purpose is to innovate to transform the lives of ... Description: As a member of the REMS Strategy and Operations department, the Senior Manager, REMS Data Programmer will provide support for FDA mandated Risk… more
- Formation Bio (New York, NY)
- …to bring new treatments to patients faster and more efficiently.About the PositionThe Senior Director , Regulatory Affairs lead is responsible for developing ... marketing Formation Bio's assets. This role includes the lead regulatory responsibility for support of global registration...the lead regulatory responsibility for support of global registration and life cycle support and the leadership… more
- Merck & Co. (Upper Gwynedd, PA)
- …analysis, regulatory reporting, and publication. -- Responsibilities: Specifically, the Senior Director may be responsible for: -Analyzing and summarizing ... Job DescriptionOur company is a global health care leader with a diversified portfolio...radically changes the way we approach serious diseases. --The Senior Director will report to an Associate… more
- Merck & Co. (North Wales, PA)
- …relevant teams, driving the strategy from ideation to value realization.- The Senior Director will: Drives Alignment and Strategic PlanningInspires teams toward ... compliance of the teams executing processes according to SOP to meet global regulatory and internal standards. Champions Continuous ImprovementLeads or supports… more
- Insmed Incorporated (NJ)
- …for each other, and for the future of science, we're in. Are you?About the Role:The Senior Director , Head of US HCP Marketing for our TPIP program in Pulmonary ... tactical execution tailored to each geography.Franchise CollaborationPartner closely with the Senior Director , HCP Marketing Lead (PH-ILD/IPF/PPF) to ensure… more
- Formation Bio (New York, NY)
- …on-board products with strong IP potential, and thereafter coordinate patent and regulatory activities to deliver best-in-class IP positions. We expect this person ... out-licensing transactions Demonstrated ability to manage multiple law firms / global patent portfolios Experience drafting claims and prosecuting patents (with… more
- Insmed Incorporated (NJ)
- …for each other, and for the future of science, we're in. Are you?About the Role:The Senior Director , Head of US HCP Marketing for our brensocatib program in HS ... Supply, Global Brand Strategy Team, etc)Work closely with Legal, Regulatory , Compliance, Medical Affairs, Market Access, Advocacy, and Commercial Operations team… more
- Insmed Incorporated (San Diego, CA)
- …strategy, identifying risks, interpreting regulations and providing guidance to ensure global regulatory compliance and the development of assigned programs ... future of science, we're in. Are you?About the Role:The Director , Regulatory Affairs will serve as the...Regulatory Affairs, lead the development and implementation of global regulatory strategy plans to facilitate efficient… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Senior Director of Human Factors (HF) will provide visionary leadership and strategic direction for the HF function within our company. This ... principles to enhance patient safety and product usability. The Senior Director will champion enterprise-wide HF strategy,...growing HF teams in a regulated environment.Deep knowledge of global HF regulatory requirements, FDA guidance, and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Summary The Associate Director , Global Oncology Medical Affairs, Medical Analytics will be responsible ... for cardiovascular diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily… more
- Eisai, Inc (Nutley, NJ)
- …mgmt. activities. #LI-CCEisai Salary Transparency Language:The base salary range for the Senior Director , Clinical Quality Assurance - Remote-Based is from ... (QAP) position is responsible for design, delivery and execution of the global Clinical Quality Assurance (CQA) strategy including audit and inspection management,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …community. Relationships The Director , Real World Science reports to the Senior Director of Real-World Data Strategy, Informatics and Science. The ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...you ready to make a difference? The Position The Director , Real World Science leads the evidence strategy and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Global Product Team in collaboration with Clinical Development, Regulatory , Project Management, Biostatistics, Pharmacology, and other departments to ... diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi...rare diseases and immune disorders. Job Summary: The Sr. Director , Clinical Safety MD, will lead the development and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …priorities. This role translates the corporate digital vision set by the Senior Director into best-in-class digital experiences, driving audience engagement, ... the Director , Digital, Content & Channels. Key relationships include senior leaders, corporate communications, product communications, Brand teams and Global … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Reports to the Director , Media & Stakeholder Relations, and interacts with senior leaders across all areas of Novo Nordisk US Operations (USO), including USO ... work together to change lives for the better. The Position The Associate Director , Media Relations & Issues Management is accountable for establishing and leading… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …(drug/event), narrative development, and case assessment Ensure alignment with evolving regulatory requirements and industry best practices Global Coordination ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...within Intake and Triage, Medical Review, Submissions and Compliance, Global Safety, and centralized teams (eg, Training and Documentation,… more
- Legend Biotech USA, Inc. (Philadelphia, PA)
- …PA or Somerset, NJ. Role OverviewWe are seeking a highly experienced and strategic Senior Director of Toxicology to lead and oversee all nonclinical safety ... Legend Biotech is a global biotechnology company dedicated to treating, and one...the treatment of multiple myeloma.Legend Biotech is seeking Sr. Director of Toxicology as part of the Clinical Development… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Global Clinical Supply (GCS) organization is accountable for managing the 'end-to-end' integrated clinical supply chain across our company ... (as a lead GCS Planning program representative) such as clinical development, regulatory , quality and other supply chain areas to negotiate timelines, strategies and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- … leaders, stakeholders and VP with other operational units across NNI and global functions; Drive effective decision-making within CDSE senior leadership Support ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...effective deliverables Prior experience influencing effectively in a matrixed, global environment Novo Nordisk is currently in the process… more
- Merck & Co. (North Wales, PA)
- …role will focus on supporting HPV. Under the guidance of an Executive Director , within the Value and Implementation, Outcomes Research the incumbent has the ... of patient reported outcomes, epidemiological studies and economic modeling.The Director also works closely with Product Development Teams, Franchise Teams,… more
