- Insmed Incorporated (NJ)
- …You'll Do: Title/Level will be determined upon evaluation of credentials and experience . Lead development and execution of global regulatory strategies for ... future of science, we're in. Are you?About the Role:The Global Regulatory Lead (GRL) will be responsible...assigned programs. This role will provide regulatory input to global cross-functional project teams throughout product development … more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Executive Director and Global Lead , Patient Advocacy & Strategic Alliances position resides in the Value & Implementation (V&I) organization, ... team's engagement with Global Clinical Trial Operations (GCTO) and Data Project Lead (DLP) teams to ensure and assist awareness and recruitment efforts in the… 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 ... for the future of science, we're in. Are you?About the Role:The Director, Global Medical Training Strategy will be responsible for developing the strategic training… more
- Merck & Co. (Rahway, NJ)
- …with applicable regulatory, quality, company, and customer requirements.-This position will lead cross-functional development teams within and external to Device ... to positively support and influence clinical and commercial combination product development and launches.Principal Responsibilities: Lead and set direction for… more
- Merck & Co. (Durham, NC)
- Job DescriptionWe're looking for a Director of Quality Assurance to lead quality across the full value chain for a late-stage ophthalmic program. In this role, ... guiding strategy, ensuring compliance, and enabling manufacturing excellence from development through commercialization. You'll partner across Quality, Regulatory, Technical,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and groups throughout the US organization, Clinical Development , Research & Early Development , other affiliates, and the Global HQ teams. We are looking for ... of objectives based on engagement objectives and sales forecasts. Lead the development and execution of annual...liaison with the global launch office and global brand team for development of a… more
- Merck & Co. (Rahway, NJ)
- …include:Function as Business System Owner (BSO) of the current Documentum-based global submission content management solutionCo- lead the implementation of the ... ONSITE 3 DAYS PER WEEK)The Submissions Content Source Management Business Operations Lead is expected to understand the end-to-end regulatory submission process. The… more
- Insmed Incorporated (NJ)
- …Technical Operations leadership team and contribute significantly to our overall product development strategy.You'll lead both drug substance (API) and drug ... launch.Deep knowledge of small molecule process chemistry, formulation, and analytical development .Demonstrated success in regulatory submissions and global CMC… 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 ... intelligence to facilitate development of regulatory strategy.- Assist the global regulatory lead in authoring of regulatory strategy documents.Collaborating… more
- Insmed Incorporated (NJ)
- … development timelines and quality standards.This position offers the opportunity to lead cutting-edge gene therapy development while building and inspiring a ... so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of...seeking a highly experienced and visionary Vice President, Product Development - CMC, Gene Therapy and Large Molecules, to… more
- Insmed Incorporated (NJ)
- …business needs. This role requires strategic thought leadership and hands-on program development and facilitation in a fast-paced, global environment.What You'll ... Do: Develop, own, and continuously improve the learning curriculum for global senior leadershipDesign and deliver impactful executive development initiatives,… more
- Merck & Co. (North Wales, PA)
- … Lead is responsible for developing and implementing a global headquarters strategic patient engagement plan aligned with therapeutic objectives ensuring ... IT Global Medical Proficiency and External Affairs (GMPEA) Global Clinical Development (GCD)Required Qualifications, Skills, & ExperienceMinimumAdvanced… more
- Merck & Co. (Rahway, NJ)
- …to internal and external manufacturing sites, process validation, second generation process development and health authority licensure. - You'll lead the charge ... seeking a strategic and technical leader with expertise in cell culture development & commercialization to spearhead our ever growing and dynamic late-stage… more
- Merck & Co. (Boston, MA)
- …Therapeutic Area and strategy, bridging Discovery Research through Late-Stage Clinical Development . The Therapeutic Area (TA) Lead will provide strategic ... extensive network of key cross- functional partners both within TMed, Discovery, and Global Clinical Development .The candidate will be expected to understand the… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Development and Commercialization Team (DCT) leader is-accountable for delivering a fully integrated stage-appropriate CMC development and ... influence, advocacy, & negotiation with stakeholders. Influences and challenges the product development team's strategy to ensure a robust CMC strategy is achieved.-… more
- Merck & Co. (Rahway, NJ)
- …to deliver services and applications that enhance communication effectiveness, support global messaging, and drive innovation in how our Company communicates with ... our Company communications teams. Key Responsibilities Product Strategy & Roadmap Lead and manage IT applications supporting corporate communications, serving as the… more
- Merck & Co. (Millsboro, DE)
- …our Global Science & Technology Network leadership team to lead complex, site-to-site technology transfers for Animal Health vaccines across our US ... sponsors, while driving portfolio governance and alignment with our Network & Strategy Development Office. This role is based at a US manufacturing site and focuses… more
- Merck & Co. (Rahway, NJ)
- …seeking a strategic and technical scientist with expertise in cell culture development & commercialization to spearhead our ever growing and dynamic late-stage ... instrumental in supporting DS commercialization, process characterization, control strategy development , tech transfer to internal and external manufacturing sites,… more
- Merck & Co. (Rahway, NJ)
- …to customers both internal and external to GCS and serves as the lead GCS spokesperson at clinical and development related meetings.- Working independently, ... Job DescriptionThe Global Clinical Supply (GCS) organization is accountable for...lead GCS Planning program representative) such as clinical development , regulatory, quality and other supply chain areas to… more
- Merck & Co. (North Wales, PA)
- …KPIs.Branded Campaign: Collaborate with Global Marketing to define, design and lead development and execution of US branded promotional campaigns and ... for future leadership roles.Key Responsibilities include, but are not limited to:HCP Strategy: Lead a cross-functional team ( Global , HHDDA, RDMA, and others) to… more
