- 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
- Eisai, Inc (Nutley, NJ)
- …make a difference. If this is your profile, we want to hear from you. The Director , Global Regulatory , Growth Markets will be responsible for providing ... management of staff.Determining timelines and budgets for program activities and report accordingly. Lead and participate in global regulatory initiatives and… more
- Merck & Co. (Rahway, NJ)
- …- Functional Area: Regulatory Innovation and Information Management (RIIM) within Global Regulatory Affairs & Clinical Safety (GRACS) - The Associate ... Job Description Associate Director , Regulatory Submissions Archive Operations -...user requirements, workflows, and metadata standards. Ensure compliance with global regulatory standards and internal SOPs for… more
- Eisai, Inc (Nutley, NJ)
- …is responsible for the leadership and oversight of the Labeling function within Global Regulatory Services and Operations (GRSO). This position will manage ... regulations governing labeling of pharmaceutical products globally, and serves as the global regulatory labeling representative on relevant project teams to… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Executive Director and Global Lead , Patient Advocacy & Strategic Alliances position resides in the Value & Implementation (V&I) ... Global Clinical Trial Operations (GCTO) and Data Project Lead (DLP) teams to ensure and assist awareness and...experience in global patient advocacy and engagement activitiesUS/ global experience in regulatory affairs, medical and… 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
- 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
- Merck & Co. (Rahway, NJ)
- Job DescriptionSr. Principal Scientist - Device Technical and Engineering Lead (Sr. Director Equivalent)Our company's Device Product & Process Development (DPPD) ... regulatory , quality, company, and customer requirements.-This position will lead cross-functional development teams within and external to Device Development &… more
- Genmab (NJ)
- …like a fit? Then we would love to have you join us!Overview:The Director , Feasibility Lead , will drive the implementation of strategic, data-driven feasibility ... internal processes, mentoring team members, and contributing to cross-functional strategies.The Director will lead complex feasibility initiatives and serve as… more
- Eisai, Inc (Nutley, NJ)
- …along with a proven track record in inspection-facing roles and global regulatory compliance.Essential Functions Clinical Outsourcing Designs and executes ... Director of Clinical Outsourcing provides strategic leadership for global outsourcing and vendor management activities within clinical development. This role… 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
- Merck & Co. (Lenexa, KS)
- …and ability to successfully partner cross functionally with all business units, regulatory , legal, and with Global Marketing colleagues Demonstration of computer ... engine across our US Animal Health portfolio. You will lead a team that owns digital demand creation and...(beef, dairy, swine, poultry, aquaculture). Reporting to the Executive Director , Channel Operations & Engagement, you will connect brand… more
- Insmed Incorporated (NJ)
- …diseases. Reporting to the VP, Clinical Development - Gene Therapy, the Executive Director will have responsibility to lead clinical programs across different ... so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of...Are you?About the Role:We're looking for an Executive Medical Director of Ophthalmology, Clinical Development to help us expand… more
- Merck & Co. (North Wales, PA)
- Job DescriptionRole SummaryThe Director Scientific Patient Engagement Lead is responsible for developing and implementing a global headquarters strategic ... the work of our company.- The Scientific Patient Engagement Lead manages and enables the planning and execution of...as well as knowledge of best practices in those areasU.S./ Global experience in clinical research, regulatory affairs,… more
- Insmed Incorporated (San Diego, CA)
- …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:We're looking for a Director , Clinical Scientist for the Gene Therapy Clinical Development team to help us… more
- Insmed Incorporated (NJ)
- …diseases. Reporting to the Head of Scientific Communications & Publications, you'll lead the development and implementation of global Medical Communications ... Communications plan for the assigned therapeutic area(s) and product(s) (pulmonology/infectious disease). Lead the creation and execution of the global medical… more
- Merck & Co. (Millsboro, DE)
- …transfer leadsStrong understanding of cGMP, PPQ, validation (process/cleaning/CSV), and global regulatory frameworks (USDA)Excellent verbal and written ... our Global Science & Technology Network leadership team to lead complex, site-to-site technology transfers for Animal Health vaccines across our US… more
- Repligen (Waltham, MA)
- OverviewMake a global impact-join Repligen.We're united by a mission to inspire advances in bioprocessing as a preferred partner in the production of biologic drugs ... Supply Chain, Product Development, and R&D organizations. As a Director of IT, you will play a key role...solutions comply with GMP (Good Manufacturing Processes) and other regulatory requirements.Partner with process owners to optimize SAP and… 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 ... accountable for creating a best-in-class team to plan, integrate and lead activities associated with moving Insmed's late-stage pipeline through clinical… 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
