- 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
- Merck & Co. (Rahway, NJ)
- Job DescriptionThis position will be part of the Device Quality & Regulatory Team within Global Regulatory Affairs and Clinical Safety (GRACS). The primary ... medical device combination quality system aspects are integratedStay abreast of evolving global regulatory landscapes for medical device and medical device… 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
- 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
- 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
- Eisai, Inc (Nutley, NJ)
- …a difference. If this is your profile, we want to hear from you. The Associate Director (AD), Global Medical Affairs Training and Education is responsible ... & International). Eisai Salary Transparency Language:The base salary range for the Associate Director , Global Medical Affairs Training and Education… 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
- Eisai, Inc (Nutley, NJ)
- …make a difference. If this is your profile, we want to hear from you. Associate Director , Medical Education - Oncology, is responsible for the strategic planning ... focus of these plans and activities will be either global , US-focused with intended use and adaptation by other...ManagementEisai Salary Transparency Language:The base salary range for the Associate Director , Medical Education - Oncology is… 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
- Merck & Co. (Rahway, NJ)
- …(Executive Director ) and Product Development Team (PDT) lead, Oncology Global Clinical Development, has primary responsibility for the planning and directing ... the indication of interest.Work closely with a cross-functional Senior/ Executive Director group of experts in commercialization, regulatory affairs, statistics,… 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
- Gilead Sciences, Inc. (Parsippany, NJ)
- …strategy, plans and objectives for assigned products or projects. You may act as the Global Regulatory Lead for early-stage or other programs. You will lead ... Regulatory Affairs and may serve as Regional Lead or Global Regulatory Lead on cross-functional/cross-regional Regulatory Submission Teams. Provides… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- **Job Description Summary** As Regulatory Affairs Associate Director , you will be responsible for leading RA team members involved in device project ... primary FDA contact in the US. You will oversee regulatory activities for the new product portfolio, primarily focusing...makers of possible** BD is one of the largest global medical technology companies in the world. Advancing the… 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