- Insmed Incorporated (NJ)
- …other, and for the future of science, we're in. Are you?About the Role:The Global Regulatory Lead (GRL) will be responsible for formulating and implementing ... contributions to meaningful progress. That commitment has earned us recognition as Science magazine's No. 1 Top Employer for...global regulatory strategies and plans to enable… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are ... and cutting-edge therapeutics for patients worldwide.Legend Biotech entered into a global collaboration agreement with Janssen, one of the pharmaceutical companies… 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...in the treatment of multiple myeloma.Legend Biotech is seeking Sr . Director of Toxicology as part of… more
- Insmed Incorporated (NJ)
- …for each other, and for the future of science, we're in. Are you?About the Role:The Sr . Director CMC QA will lead QA CMC oversight for drug products, biologics, ... so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of...contributions to meaningful progress. That commitment has earned us recognition as Science magazine's No. 1 Top Employer for… more
- Repligen (Waltham, MA)
- …global public company is seeking a strong, experienced, and technically sound Senior Director , Assistant Corporate Controller who will oversee the Company's ... OverviewMake a global impact-join Repligen.We're united by a mission to...accordance with GAAP.Ensure timely and accurate financial reporting to senior management and external stakeholders, including quarterly and annual… 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
- Insmed Incorporated (NJ)
- …and for the future of science, we're in. Are you?About the Role:The Senior Director , Medical Services will provide strategic leadership to Insmed's independent ... so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of...strategies to fill core educational and research gaps. The Senior Director , Medical Services will drive operational… 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
- Insmed Incorporated (NJ)
- …and for the future of science, we're in. Are you?About the Role:The Director , EHS (Environmental, Health, and Safety) isa senior -level role responsible for ... so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of...contributions to meaningful progress. That commitment has earned us recognition as Science magazine's No. 1 Top Employer for… 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders. Job Summary: The Sr . Director , Clinical Safety MD, will lead the development and ... Global Product Team in collaboration with Clinical Development, Regulatory , Project Management, Biostatistics, Pharmacology, and other departments to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …all Medical Affairs programs. This role involves deputizing for the Sr . Director , representing the Quality organization at senior levels. The Director ... studies, non-interventional studies, Compassionate Use or Managed Access Programs.Collaborate with the Sr Director , Medical Affairs QA to conduct quality reviews… 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
- Insmed Incorporated (NJ)
- …lead over an 1-2 indications within one compound, in collaboration with the Senior Director , Clinical Operations. Ensures consistent and successful execution of ... global policies and procedures. Ensure compliance with all Company/ Regulatory requirements & TMF quality standards.Work with outsourcing/procurement management to… 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
