- Daiichi Sankyo, Inc. (Bernards, 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 serve as an ad hoc member of Global Project Team (GPT)… more
- Merck & Co. (Rahway, NJ)
- …and other pharmacometric analyses-Developing and maintaining a comprehensive understanding of global regulatory expectations for small molecules and biologics, ... Job DescriptionAssociate Director - Pharmacometrics, Quantitative Pharmacology and PharmacometricsThe Quantitative Pharmacology and Pharmacometrics (QP2) department… more
- Merck & Co. (Rahway, NJ)
- …day-to-day coaching/guidance to individual contributorsMaintaining a comprehensive understanding of global regulatory expectations for small molecules and ... development (MIDD) to routinely enable efficient drug discovery/development and/or regulatory decisions. The Pharmacometrics group within QP2 brings an experienced… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and implement the preparation of US regulatory submissions and provide US regulatory support across all global projects; meet aggressive deadlines to ensure ... 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. (Bernards, NJ)
- …issues with regard to ways or working or resources to the Head of US Regulatory Affairs and/or Global Regulatory Lead for asset to reach ... diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi... global product team meetings to provide US regulatory support and guidance as needed and manage day-to-day… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. SummaryReporting to the Senior Director , I&A, the Associate Director , Global Oncology Forecasting ... drive creation of demand and revenue forecasts. The Associate Director is a dynamic member of the Global...with Market Research, Competitive Intelligence, Marketing, MA, R&D, Finance, Regulatory and Market Access internally across global … more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Global Clinical Supply (GCS) organization is accountable for managing the 'end-to-end' integrated clinical supply chain across the full our ... as a lead GCS Planning program representative ) such as clinical development, regulatory , quality and other supply chain areas to negotiate timelines ,- strategies… more
- Merck & Co. (Rahway, NJ)
- …cycle of clinical development, including study design, placement, monitoring, analysis, regulatory reporting, and publication. -- Specifically, the Director may ... Job DescriptionOur company is a global health care leader with a diversified portfolio...radically changes the way we approach serious diseases. --The Director will report to an Associate Vice President in… 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 ... to enhance decision-making and streamline operations. Ensure compliance with regulatory requirements and industry standards in all improvement initiatives.Qualifications:… more
- Merck & Co. (Rahway, NJ)
- …products and processes are developed in accordance with applicable regulatory , quality, company, and customer requirements.-This position will lead cross-functional ... full integration of the device development activities with the clinical, regulatory , formulation, commercial and other key Ofunctions.Lead the Device Development… more
- Formation Bio (New York, NY)
- …ensures that trials are executed efficiently, on time, and in compliance with all regulatory requirements. The Director will manage a team of Clinical Trial ... degree (eg, MSc, PhD, MBA) in a related field. Preferred: Experience with global clinical trials and regulatory submissions. Formation Bio is headquartered in… more
- Merck & Co. (Rahway, NJ)
- …endpoints including proportional hazards models. Maintaining a comprehensive understanding of global regulatory expectations for small molecules and biologics in ... - Immune/Oncology (QP2-IO) team in the role of Associate Director QP2-IO team is part of the Global...Oncology, authoring regulatory documents (investigational new drugs/INDs, clinical study reports (CSRs),… 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
- Formation Bio (New York, NY)
- …bring new treatments to patients faster and more efficiently.About the PositionThe Sr. Director , GMP Quality Assurance will lead the GMP QA strategy and execution ... release, stability programs, change management, and vendor oversight. The Sr. Director ensures compliance with cGMP standards, oversees QA activities at CDMOs,… 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 ... areas centered around rare diseases and immune disorders. JOB SUMMARYThe Associate Director , GMP QA Process Excellence is accountable to collect information, analyze… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Global Product Team in collaboration with Clinical Development, Regulatory , Project Management, Biostatistics, Pharmacology, and other departments to ... for cardiovascular diseases, 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. (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 ... Headquarter to support with routine and unusual issues related with Global Products.ResponsibilitiesQuality Management System (QMS): Ensures and support that 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 ... areas centered around rare diseases and immune disorders. Job Summary: The Director of Data Management (DM) Reporting provides leadership in Data Management… 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 ... at each phase of the development are scientifically sound, can fulfill regulatory requirements and deliver the pre-specified product profile.- CRO / Vendor… more
