- Insmed Incorporated (NJ)
- …each 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 ... product development and submission activities. The GRL will serve as the global regulatory lead for documentation review prepared by other technical… more
- Merck & Co. (Rahway, NJ)
- …resource allocation, organizational structures, and alignment with R&D and regulatory requirements.Team Leadership: Lead , mentor, and develop a high-performing ... Job DescriptionRole Overview:The Customer Marketing Director will be responsible for shaping and spearheading the development and global deployment of the… more
- Merck & Co. (Rahway, NJ)
- …ONSITE 3 DAYS PER WEEK)The Submissions Content Source Management Business Operations Lead is expected to understand the end-to-end regulatory submission process. ... include:Function as Business System Owner (BSO) of the current Documentum-based global submission content management solutionCo- lead the implementation of the… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …meetings Lead cross-functional improvement projects with stakeholders from Quality, Regulatory Affairs, IT, and Global Units Manage change initiatives to ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...The Position The Patient Safety, Compliance & Operational Excellence Lead is responsible for driving efficiency, quality, and innovation… more
- Formation Bio (New York, NY)
- …and marketing Formation Bio's assets. This role includes the lead regulatory responsibility for support of global registration and life cycle support ... treatments to patients faster and more efficiently.About the PositionThe Senior Director , Regulatory Affairs lead is responsible for developing and directing… more
- Genmab (NJ)
- …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 Medical ... diseases. We strive to create, champion and maintain a global workplace where individuals' unique contributions are valued and...and work in a highly dynamic and collaborative setting.The Director , HEOL Team Lead is part of… more
- Insmed Incorporated (San Diego, CA)
- … Regulatory Affairs, lead the development and implementation of global regulatory strategy plans to facilitate efficient and driven product ... strategy, identifying risks, interpreting regulations and providing guidance to ensure global regulatory compliance and the development of assigned programs… more
- Insmed Incorporated (NJ)
- …understanding of US, EU, and Japanese regulations for human drugs/biologics.Knowledge of global regulatory guidance documents and regulations with emphasis on ... of science, we're in. Are you?About the Role:The Associate Director , Regulatory Affairs, CMC will be responsible... strategies for post-approval changes. This role will also lead CMC regulatory strategy development and implementation… 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)
- …patient counts - and so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare ... 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 creating… more
- Insmed Incorporated (NJ)
- …patient counts - and so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare ... future of science, we're in. Are you?About the Role:The Director of Clinical Supply Chain Operations is responsible for...of Clinical Supply Chain Operations is responsible for leading global demand planning and ensuring the successful delivery of… more
- Insmed Incorporated (NJ)
- …regulatory documents for agency meetings.Provide interpretation of applicable FDA/EMA/ICH/WHO global regulations to ensure CMC compliance within regulatory ... methodologies to ensure the company's RA CMC activities are aligned with regulatory expectations. Lead and mentor a team of CMC professionals, encouraging… 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
- Insmed Incorporated (NJ)
- …global policies and procedures. Ensure compliance with all Company/ Regulatory requirements & TMF quality standards.Work with outsourcing/procurement management to ... so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of...can be hybrid or remote.What You'll Do: Primary operational lead over an 1-2 indications within one compound, in… more
- Insmed Incorporated (NJ)
- …patient counts - and so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare ... the future of science, we're in. Are you?About the Role:The Associate Director , Patient Services Quality & Process leads quality assurance and process improvement… more
- Insmed Incorporated (NJ)
- … regulatory requirements while maintaining operational excellence. The Executive Director , Cybersecurity & Risk Management plays a critical leadership role in ... patient counts - and so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare… 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
- Genmab (NJ)
- …like a fit? Then we would love to have you join us!The Regional Business Director will help recruit, hire, develop, and lead his/her sales team in hematology ... and serious diseases. We strive to create, champion and maintain a global workplace where individuals' unique contributions are valued and drive innovative solutions… more
- Merck & Co. (Rahway, NJ)
- …and lead a cross functional team members to support global commercialization and technology transfer activities and drive product robustness for sustained ... Job DescriptionJob Summary: -The Associate Director of Device Technology is a key leadership role within the Device Development and Technology Organization. This… more
- Merck & Co. (Rahway, NJ)
- …with a focus on autoinjectors, prefilled syringes, and other drug delivery systems. The director will lead a team of engineers and technical staff to support ... Job DescriptionJob Summary: The Director , Combination Product Commercialization is a key leadership... global and site-specific projects, facilitate technology transfer, and drive… more
