- Insmed Incorporated (NJ)
- …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 global ... meaningful progress. That commitment has earned us recognition as Science magazine's No. 1 Top Employer for four consecutive...submission activities. The GRL will serve as the global regulatory lead for documentation review prepared by… more
- Merck & Co. (North Wales, PA)
- …with Agencies and attending Agency meetings as needed to assist the global regulatory lead .Participating as an active member on the global regulatory ... people and animals. We use the power of leading-edge science to save and improve lives around the world.... precedence, and competitive intelligence to facilitate development of regulatory strategy.Assisting the global regulatory lead… more
- Merck & Co. (Rahway, NJ)
- …President, Clinical and Development Digital Solutions (CDDS IT), the Executive Director, Digital Regulatory and Safety, will lead our efforts in transforming ... people and animals. We use the power of leading-edge science to save and improve lives around the world.Reporting...Develop and promote a multiyear product strategy for Digital Regulatory & Safety, aligning with IT and Research and… more
- Formation Bio (New York, NY)
- …pertaining to developing and marketing Formation Bio's assets. This role includes the lead regulatory responsibility for support of global registration and life ... patients faster and more efficiently.About the PositionThe Senior Director, Regulatory Affairs lead is responsible for developing...BSc, MS, MSc, PhD, PharmD, JD, or MD in science or healthcare preferred or equivalent relevant experience. Has… more
- Insmed Incorporated (NJ)
- … regulatory strategies for post-approval changes. This role will also lead CMC regulatory strategy development and implementation in coordination with ... meaningful progress. That commitment has earned us recognition as Science magazine's No. 1 Top Employer for four consecutive..., we're in. Are you?About the Role:The Associate Director, Regulatory Affairs, CMC will be responsible for reviewing the… more
- Merck & Co. (Durham, NC)
- …12.5 hour (6:30 PM-6:30AM) rotation (2-2-3). - The Vaccine Manufacturing Facility Lead Technician is an excellent opportunity for highly motivated individuals with ... expertise working in aseptic production and manufacturing operations. -The Lead Technician is a manager developmental role and will serve on the Operations… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …outcomes. Are you ready to realize your potential? The Position The Regional Lead of State Government Affairs sits within the State Government Affairs Team. This ... organizations that could negatively affect our business or patients. The Regional Lead is accountable for relationships with state level appointees within an… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 125 years of scientific expertise and ... areas centered around rare diseases and immune disorders. SummaryThe Study Delivery Lead (SDL) leads the cross functional core and extended clinical study team… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking QA Investigations Lead I as part of the Quality team based in Raritan, NJ. Role ... OverviewThe QA Investigation Lead is an exempt level position reporting to the...in the delay of investigation closure and product release.Support regulatory inspections and audits by ensuring inspection readiness within… more
- Novo Nordisk Inc. (WA)
- …health outcomes. Are you ready to realize your potential? The Position The Team Lead , State Government Affairs oversees the State Lobbyist team, in all aspects of ... effective collaboration and ensure progress toward Novo Nordisk legislative and regulatory objectives Builds organizational alignment on key issues by informing and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …the lives of more patients than ever before. The Position The Brand Strategy Lead is pivotal in developing brand level objectives and strategic priorities. They will ... including sales, marketing, medical affairs, market access and policy/advocacy (MAPA), regulatory affairs, and other relevant NNI departments to ensure alignment of… more
- Genmab (NJ)
- …compassionate, candid, and purposeful, and our business is innovative and rooted in science . We believe that being proudly authentic and determined to be our best ... RoleGenmab is currently seeking a Director, HEOL (Health Evidence and Outcomes Liaison) Team Lead to be a part of an exciting, passionate, high profile, high impact… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking QA Investigations Lead III as part of the Quality team based in Raritan, NJ. Role ... OverviewThe QA Investigations Lead is responsible for providing quality oversight over the production of a personalized cell therapy to support both clinical and… more
- Merck & Co. (North Wales, PA)
- …biostatistical support for related drug/vaccine projects in Late Development Statistics. Lead the interaction with Clinical, Regulatory , Statistical Programming, ... Clinical Trials, Clinical Trials Analysis, Data Analysis, Data Management, Data Science , Numerical Analysis, Project Management, Regulatory Compliance, … more
- Insmed Incorporated (NJ)
- …contributions to meaningful progress. That commitment has earned us recognition as Science magazine's No. 1 Top Employer for four consecutive years, certification as ... patients, for each other, and for the future of science , we're in. Are you?About the Role:We are seeking...diseases. Reporting to the SVP, Technical Operations, you will lead all Chemistry, Manufacturing, and Controls (CMC) activities for… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From healthcare provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Syner-G BioPharma Group (Boston, MA)
- …DESCRIPTION: Syner-G is a science -led, strategic partner for life science companies. We provide integrated regulatory and biopharmaceutical development ... supporting critical phases of the drug development lifecycle, from discovery and regulatory approval to technology transfer and the support in capital projects. We… more
- Merck & Co. (Lower Gwynedd, PA)
- …we will combine the power of innovative robotics, IT platforms, and science to accelerate vaccines and enable late-stage clinical trials through the generation ... utilized to generate pivotal safety and efficacy clinical patient data required for regulatory filings. -As the AdVAnce facility will not be fully constructed and… more
- Merck & Co. (Rahway, NJ)
- …strategic direction for a global, cross-modality technical team. The Director will lead a team of technical experts responsible providing Center of Excellence ... substance and drug product container closure systems including mold qualification and regulatory compliance.- To act as master data stewards and support enterprise… more
- Insmed Incorporated (NJ)
- …contributions to meaningful progress. That commitment has earned us recognition as Science magazine's No. 1 Top Employer for four consecutive years, certification as ... patients, for each other, and for the future of science , we're in. Are you?About the Role:We are seeking...diseases. Reporting to the SVP, Technical Operations, you will lead our gene therapy and large molecules pipeline from… more
