- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …diseases and immune disorders.Summary The Director , Head of Global Dossier Planning , Regulatory Operations is responsible for leading the dossier planning ... major submissions globally. The Director of Dossier Planning will ensure high quality regulatory submissions...in all regions. The Director of Dossier Planning will report to Head of Global Regulatory… more
- Creative Financial Staffing (Columbus, OH)
- …posting journal entries. Coordinate with the Chief Administrative Officer and Executive Director for annual budgeting, planning process, and overall timelines ... reporting systems ensuring compliance with appropriate GAAP standards and regulatory requirements. Maintains internal financial control and auditing regarding… more
- Merck & Co. (Rahway, NJ)
- … regulatory filing, and publication. Specifically, The Senior Clinical Director May Be Responsible For: Evaluating pre-clinical and translational work for ... Job DescriptionThe Senior Clinical Director (Sr. Principal Scientist) has primary responsibility for the strategic planning and directing clinical research… more
- Eisai, Inc (Nutley, NJ)
- …to hear from you. Job Summary: As the Americas IT Security and Compliance Director , you play a pivotal role in ensuring the organization's adherence to security, ... regulatory , and compliance standards. Collaborating with business and EIT...Decisions for Eisai Americas IT Compliance and Security: investment planning , business outcomes, budgeting and systems related decisions.Directs priorities… more
- Merck & Co. (Rahway, NJ)
- …processes/ methods in conformance to all applicable regulatory requirements, regulatory filings and company policies.The Associate Director also ensures that ... Job DescriptionThe Associate Director , ESQL is responsible for all activities at...EQA and Division in specific Quality systems, technology platforms, regulatory expectations and/or EE management, and can represent the… 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
- 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
- Merck & Co. (Durham, NC)
- …new HPV vaccine drug substance manufacturing facility. As a direct report to the Director of Operations, the Associate Director will be accountable for the ... transfer of the HPV vaccine manufacturing process while ensuring compliance with all regulatory and safety guidelines. Lead a diverse team and be accountable for all… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …to entire drug development plans with minimal supervision and authors regulatory responses and other documents with minimal supervision. This position interacts ... in using the most efficient or innovative study design by considering the regulatory agencies' requirements for the country and Regions the compound will be… more
- Merck & Co. (Rahway, NJ)
- …the company as needed (including Senior Executives) and working closely with Regulatory , Legal, Manufacturing, Technical Transfer, Supply Planning and Global ... Job DescriptionCompanion Animal Global Marketing - Director , Parasiticide Portfolio MarketingThe Companion Animal (CA) Business unit leads strategy development and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Directive, and International Conference on Harmonization (ICH) guidelines. The Associate Director is accountable for operational planning and execution at ... quality standards and timelines and that quality of data is suitable for regulatory submission. The Associate Director will have routine interaction with key… more
- Merck & Co. (North Wales, PA)
- Job DescriptionThis position drives scientific planning , strategy and execution of Phase 1-4 clinical studies.-Under the direction of the Program Lead, you will ... trial team.Collaborates with the Medical Writer on clinical/scientific and regulatory documents.Partners with Study Manager on study deliverables.Participates in the… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …collaborates with external KOLs to refine study plans; Prepares and participate in regulatory agency meetings, if applicable.Study Planning and Execution: As CSL ... Such trials could be pivotal for submission; Prepares clinical section of regulatory documents; Oversees management and performance of CRO; Participates in creation… more
- Merck & Co. (Rahway, NJ)
- …innovative medicines that help people across the globe. Competitive Intelligence Director Individual will be responsible for providing Competitive Intelligence (CI) ... the identification and prioritization of intelligence efforts critical to strategic planning and execution for key stakeholders and will provide direction for… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …for managing the multiple Clinical Science Asset Leaders (CSALs) at the Senior Director level for each respective programThis Clinical Science (CS) Group Lead will ... programsThe CS group lead will also contribute to the program study strategy, planning , execution, and reporting outputs in collaboration with the CS Asset LeadsThe… 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
- Eisai, Inc (NJ)
- …communication/publication components of overall medical operating plan. The Medical Director provides strategic development, planning , implementation and ... If this is your profile, we want to hear from you. The Medical Director , US Medical Affairs provides medical leadership for medical affairs strategy, planning … more
- Eisai, Inc (Nutley, NJ)
- …is your profile, we want to hear from you. Job Summary The Medical Director will provide medical leadership for medical affairs strategy, planning and supportive ... tactics for assigned therapeutic area. Under the direction of the Senior Medical Director , this role will be responsible for working with key stakeholders to develop… 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 ... decision-making at our company, this position offers an opportunity for the Director to drive pipeline impact and mentor/coach a talented group of… more
- Catalent (Harman, WV)
- Senior Director , Supply Chain Position Summary: The Senior Director , Supply Chain is responsible for leading the supply chain organization for Catalent Maryland. ... coming online.Reporting to the Vice President and General Manager, the Senior Director Supply Chain directs all facets of supply chain management including, but… more
