- Merck & Co. (North Wales, PA)
- …Document for projects of increasing complexity.Lead development and execution of detailed, global regulatory submissions of INDs, BLAs or post approval change ... Job DescriptionUnder general supervision of an Executive Director /Senior Director , the Principal Scientist /...responsibilities include but are not limited to:Serve as a Regulatory CMC Project Lead and provide CMC… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …rare diseases and immune disorders.Summary Responsible for leading and developing global regulatory strategy for assigned development projects. Represents ... meetings globally. Responsible for representing GRA in the GPT ( Global Project Team) as well representing the...into a global strategy.Responsible for ensuring aligned global regulatory strategy is endorsed by GPT… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …to make a difference?The Position We are seeking a collaborative and science-driven global regulatory expert who wants to work with innovative investigational ... medicines. You will lead a global regulatory team to...Denmark. Essential Functions Serve as a member of the Global Project Team (GPT) utilizing precedent and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …disorders. Summary This position serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational ... leadership on product labeling in collaboration with Global Regulatory Leads (GRLs). This position may...position may serve as an ad hoc member of Global Project Team (GPT) to address labeling… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionPosition Description: Director , Global Oncology Communications The role of Director , Global Communications, Oncology is a unique ... for this role will work under the guidance of the Executive Director , Global Oncology Communications in a fast-paced and ever-changing… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …early/late stage drug development experience ideally including time in role such as a Global Project Leader at Sr. Director level or equivalent preferred- ... research areas centered around rare diseases and immune disorders.Summary The Executive Director , Global Clinical Operations Study Management Group Head has… more
- Merck & Co. (Rahway, NJ)
- …LATAM and APAC. Leads site EHS leaders and influences site, region and global business partners to drive prioritization of regulatory compliance, continuous ... 25% international travel is required Preferred Experience and Skills: Experience leading global , matrixed teams. Project planning and execution across a diverse… more
- Merck & Co. (Rahway, NJ)
- …SkillsKnowledgeable of the Capital Process having participated on a large capital project team.Experience in regulatory compliance expectations across all phases ... Job DescriptionOur company is a global healthcare leader with a diversified portfolio of...modalities including small molecules and peptides.- Within OFS, the Director will influence the strategy, lead activities, and develop… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …centered around rare diseases and immune disorders. SummaryLeadership responsibility for global regulatory strategy to support the development of biomarkers, ... partner side) CDx RA Policy and Intelligence: Keep abreast of the changing global regulatory environment for devices and share/educate CDx department on these… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …documents, breakthrough therapy designation requests, orphan drug applications.Participate in global project team meetings (development and/or marketed ... and implement the preparation of US regulatory submissions and provide US regulatory support across all global projects; meet aggressive deadlines to ensure… more
- Eisai, Inc (NJ)
- …and governance meetings and lead processes improvement initiatives as required.Report to Director on issues and global strategies.Manage, mentor and develop ... is your profile, we want to hear from you. Job Summary The Associate Director , Clinical Outsourcing, will oversee and lead and support activities related to the… more
- Insmed Incorporated (Bridgewater, NJ)
- …discipline. DABT/DACVP certification preferred.Minimum of 15 years of experience as a regulatory toxicologist (study director /monitor and/or project lead) in ... Company DescriptionInsmed is a global biopharmaceutical company on a mission to transform...New York™, and Best Workplaces for Millennials™ lists.OverviewThe Senior Director , Toxicology is a key member of the nonclinical… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- … project activities Understands high level import/export requirements for global distribution of clinical ancillary materials and ensures the appropriate ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...ready to make a difference? The Position The Assoc Director OED - Supplies, is responsible for US and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …quality strategy closely aligned with the business strategy within one or more Global Project Team(s) (GPT) within Oncology Development Franchises or Business ... medicines to help people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …medicines to help people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily ... Provide strategic leadership for all statistical programming activity related to study, project and submission. Manage CRO to ensure high quality compound and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …diligence activities and represents global function on study and project teamsProduces independent writing for publications & regulatory documentsServes as ... PK-PD and Pop PK-PD analyses,Participates in KOL and regulatory interactions at project level, interacts with regional and global study and project … 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 health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …commitment to confidentiality and routinely handles sensitive documents that may impact multiple Global organizational units or Global project teams. The ... to date- Support regulatory inspection related activities as required- Support Head, Global strategy and operations to develop and plan the Global QA… more
- Merck & Co. (Rahway, NJ)
- …compliance councils. Key performance indicators range from quality and regulatory compliance, operational excellence, pipeline program support, financial, talent ... functional groups in development, quality, safety, facilities management, analytical, finance and regulatory .-FLEx was designed to be a facility that evolves to meet… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …the Global Product Team in collaboration with Clinical Development, Regulatory , Project Management, Biostatistics, Pharmacology, and other departments to ... medicines to help people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily… more
