- Daiichi Sankyo, Inc. (Bernards, NJ)
- …partner side) CDx RA Policy and Intelligence : Keep abreast of the changing global regulatory environment for devices and share/educate CDx department on these ... procedures.Understanding of strategic and tactical role and deliverables of Global Regulatory Strategy in the Drug and Device Development and Commercialization… more
- Daiichi Sankyo, Inc. (Bernards, 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 ... contract manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC...team and serves as ad hoc member to the Global Project Team for late stage projects. This position… more
- Merck & Co. (Rahway, NJ)
- …West Point, PA / Rahway, NJ is seeking a curious and collaborative Associate Director to support our rapidly expanding cardiometabolic and ophthalmology ... pipelines. - As an Associate Director , you will represent QP2 on...and interpretation of data. Maintain a comprehensive understanding of global regulatory expectations and shape, present and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …design pull you in? Are you ready to experiment with us? The Position The Associate Director of Nephrology Key Opinion Leader Marketing will be a pivotal driver ... with brand/therapy area vision and message. Relationships Reports to Senior Director of Cardio Renal Marketing Responsible for providing interface with key… more
- Merck & Co. (Rahway, NJ)
- …Pharmacology and Pharmacometrics - Immune/Oncology (QP2-IO) team in the role of Associate Director , Quantitative Systems Pharmacology (QSP) . QP2-IO team is ... of oncology drugs from post-PCC to registration. As a subject matter expert, the Associate Director within the QP2-IO Group will work closely with teams of… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …improving the lives of more patients than ever before. The Position The Associate Director , Rare Bleeding Health Care Professional Marketing Experience has ... Partnerships and Engagement, Customer Experience and Marketing Enablement, Employee Experience, Regulatory , PRB, PSP, FRM, Conventions, Global Marketing, Launch… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …strong collaborators, as we embark on shaping our future. The Position The Associate Director , Rare Bleeding Health Care Professional Marketing Experience has ... Partnerships and Engagement, Customer Experience and Marketing Enablement, Employee Experience, Regulatory , PRB, PSP, FRM, Conventions, Global Marketing, Launch… more
- Merck & Co. (Rahway, NJ)
- …requires close collaboration and leadership of cross functional teams compromised of Global Supply Chain, Global Regulatory Affairs, Labeling, Material ... coordination of switch plans with all relevant stakeholders (Donor & Receiving Sites, Global Regulatory Affairs (Labelling), Quality and the Material Master Data… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …collaborators, as we embark on shaping our future. The Position The Associate Director , Strategic Collaboration role is responsible for fostering partnerships ... Early Development, Development, innovation hubs across NN, other affiliates, and global . We're looking for individuals who are enterprise thinkers, inclusive… more
- Merck & Co. (Rahway, NJ)
- …products. Serve as outcomes research representative on cross-functional regional and global teams.Critically assess drivers and barriers to reimbursement and market ... access, and provide input into clinical, regulatory , payer/access, marketing and evidence generation strategies and programs.In collaboration with internal teams and… more
- Merck & Co. (Rahway, NJ)
- …Manufacturing Operations, Drug Delivery Systems and Devices within our Manufacturing Division ( Associate Director ).-This role serves as a Virtual Plant Manager - ... contact for all dealings between our Company and the External Partner, the Associate Director External Manufacturing Operations is accountable for establishing a… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for cardiovascular diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily ... will collaborate globally with Formulation and Analytical Scientists, Clinical Operations, Regulatory Affairs CMC, and Clinical Development to collate the necessary… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for cardiovascular diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily ... complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs. Drafts development plans,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for cardiovascular diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily ... effective vendor programming implementation, and expedite the preparation of regulatory submissions. Responsibilities include: make strategic programming decision and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for cardiovascular diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily ... at each phase of the development are scientifically sound, can fulfill regulatory requirements and deliver the pre-specified product profile.CRO / Vendor Oversight:… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders. JOB SUMMARYThe Senior Director , Head Medical affairs Quality Assurance in Global RD/PV QA is ... (Directors, Associate Directors, Managers, contractors as applicable) across the Global Quality teams located in EU, Americas (including Brazil) and work in… more
- Sanofi Group (Morristown, NJ)
- **Job Title:** Associate Director , Global Regulatory Affairs - Global Labeling Strategy **Location** : Morristown, NJ or Cambridge, MA (Hybrid) ... families. Your skills could be critical in helping our teams accelerate progress. The Associate Director , Global Regulatory Affairs - Global Labeling… more
- Bristol Myers Squibb (Princeton, NJ)
- …both at work and in their personal lives. Read more: careers.bms.com/working-with-us . ** Associate Director , Global Regulatory Strategy, Neuroscience** ... **Position Summary:** The selected candidate will have leadership responsibility for global regulatory strategy within a development team (DT). Serve as team… more
- Merck (Rahway, NJ)
- **Job Description** This position will be part of the Device Quality & Regulatory Team within Global Regulatory Affairs and Clinical Safety (GRACS). The ... system aspects are integrated + Stay abreast of evolving global regulatory landscapes for medical device and...+ Audit vendors/partners of SaMD/IVD/Companion Diagnostics **Reports to** - Director Regulatory Compliance, Device Quality and … more
- Bausch Health (Bridgewater, NJ)
- …itwhere your skills and values drive our collective progress and impact. The Associate Director , Regulatory Affairs handles regulatory development ... Join our global diversified pharmaceutical company enriching lives through our...Participates on the product development/life-cycle management team to provide regulatory guidance for assigned pharmaceutical products. Primary focus on… more
