- Daiichi Sankyo, Inc. (Bernards, NJ)
- …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...through all labeling discussions with the FDA/CHMP while ensuring management alignment. Strategizes and plans for FDA meetings as… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …in associated contractual templates. Ensures Good Pharmacovigilance Practice and regulatory compliance in such arrangements. Oversees Local/Global ... and proactively drive operational excellence and continuous improvement. Oversees the management of Global PV Regulatory Intelligence (PVRI) and dissemination… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …planning, coordination, and implementation of Development SOP activities to ensure regulatory compliance and cross functional cohesiveness across SOPs and ... Director , Development SOP Management Join a...of view and provide guidance to authors to ensure regulatory compliance , consistency and connectiveness across SOPs.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs. Drafts development plans, ... listings, SAP, Data Mgmt plan; Reviews patient population and protocol compliance for consistency with study strategy; Develops biomarker strategy in collaboration… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …& Accounting, Tax, Compliance and Legal team members to ensure compliance with all relevant regulatory , accounting, tax and internal requirements. This ... of a company poised for continued growth. These responsibilities will include management of all day-to-day payroll operations and activities for all US (multi-state)… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …rare diseases and immune disorders. SummaryThis position serves as the Global Regulatory Affairs (GRA) Labeling Strategy expert to the Global Product Team (GPT) ... operational leadership on new product labeling in collaboration with the Global Regulatory Leads (GRLs) and Clinical Safety & Pharmacovigilance (CSPV) for assigned… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …rare diseases and immune disorders. Summary This position serves as the Global Regulatory Affairs (GRA) Labeling Strategy expert to the Global Product Team (GPT) as ... operational leadership on new product labeling in collaboration with the Global Regulatory Leads (GRLs) and Clinical Safety & Pharmacovigilance (CSPV) for assigned… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …limited to Clinical Operations, Clinical Development, Biostatistics and Data Management , Regulatory Affairs, Quantitative Clinical Pharmacology, Clinical Safety ... and Pharmacovigilance, Regulatory /Risk Management , Quality Assurance, Medical Affairs, Translational...architecture. Advocates for good architecture and design practices and compliance in all relevant areas. Assists IT and business… more
- Merck & Co. (Rahway, NJ)
- …device and combination products, guiding cross-functional teams to ensure regulatory compliance throughout development and commercialization. Mentor team ... Combinations CMC (Chemistry, Manufacturing & Controls), you will report to the Director of Device Regulatory Affairs for Autoinjector Development Programs. You… more
- Merck & Co. (Rahway, NJ)
- …degree with 12+ years of industry experience, including regulatory and/or compliance area and experience with process management in a regulated ... maintaining efficient, effective, and compliant business standards, process maps, and risk management for global processes across Global Regulatory Affairs and… more
- Merck & Co. (Rahway, NJ)
- …Capital Process having participated on a large capital project teamExperience in regulatory compliance expectations across all phases of product development to ... portfolio. Within Biologics and Biopharmaceutics, the large molecule product development Director will influence the strategy, lead activities, and develop a team… more
- Merck & Co. (Rahway, NJ)
- …site, region, and global business partners to drive prioritization of regulatory compliance , continuous performance improvement, and integration of EHS ... applying regulatory frameworks and keeping abreast of the changing regulatory landscape.Strong leadership, change execution, and financial management skills… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionJob Overview:-We are seeking a highly qualified and experienced Associate Director in Data Management to lead our data management team in ... role.Expertise in Prelude software or similar dedicated data management applications.Comprehensive understanding of regulatory regulations and company… more
- Merck & Co. (Rahway, NJ)
- …development (MIDD) to routinely enable efficient drug discovery/development and/or regulatory decisions. The Pharmacometrics group within QP2 brings an experienced ... therapeutic areas and modalities to drive portfolio impact from discovery through life-cycle management . The team is externally visible and continues to be at the… more
- Merck & Co. (Rahway, NJ)
- …pharmacokinetics modeling software (eg, Simcyp, GastroPlus) is highly desired.Experience in regulatory compliance expectations across all phases of product ... compliance mindset.Essential Knowledge, Duties & Responsibilities for the Director Include:Biopharmaceutics expertise supporting delivery of small molecule, peptides… more
- Merck & Co. (Rahway, NJ)
- …chemical and biochemical processes, parenteral, oral, and specialty dosage formulations.- The director should be well engaged with regulatory and industry trends ... R&D and DSCS. --The candidate will have experience in an innovative analytical/ regulatory /GMP environment.The Director will effectively team with the SMAR&D… more
- Merck & Co. (Rahway, NJ)
- …the Research & Development pipeline and realize its full potential. The Associate Director is expected to provide project management leadership and drive ... Project Manager is part of Global Project and Alliance Management (GPAM) which sits in the Research & Division...our company. - Position Description/Summary: - The GPAM Associate Director , Project Manager, is a core member of Early… more
- Merck & Co. (Rahway, NJ)
- …transformation that reflects the evolving demands of our business. Risk Management :-Proactively identify potential technical, operational, and regulatory ... Job DescriptionWe are seeking a visionary Executive Director to lead our End-to-End Technical Leader organization...the lifecycle of product franchises, (2) project and portfolio management support across pipeline and supply, and (3) the… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionR5 - Director - Pharmacometrics, Quantitative Pharmacology and PharmacometricsT he (remote) position is only applicable for those that are not within ... development (MIDD) to routinely enable efficient drug discovery/development and/or regulatory decisions. The Pharmacometrics group within QP2 brings an experienced… more
- Merck & Co. (Rahway, NJ)
- …cross-functional development teams to enable pipeline decisions. -The Executive Director , Biologics Analytical Research and Development (B-AR&D) is responsible for ... of Biologics programs (approximately 10-15 programs), and leading multiple Director lead Development teams, overall approximately 40-50 scientists. Strategic… more
