- Merck & Co. (North Wales, PA)
- …placement, monitoring, analysis, regulatory reporting, and publication.- Specifically, the Senior Director may be responsible for: Providing scientific and ... medicines span all phases of clinical development (pre-clinical to post-licensure). The Senior Director will manage the entire cycle of clinical development,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …other research areas centered around rare diseases and immune disorders. SummaryThe Senior Director sits within Global Oncology Clinical Development, an ... the Target Product Profile (TPP)Development of clinical sections of trial-level regulatory documents (eg, response to HAs, briefing book, etc.) in conjunction… more
- Merck & Co. (Rahway, NJ)
- …Description:The Director of Chemical Biotechnologies reports to the Senior Director Chemical Biotechnologies in Process Research & Development ... external presentations.--Nature and Scope of Position:This role reports to the Senior Director of Chemical Biotechnologies within Enabling Technologies, Process… more
- Merck & Co. (Millsboro, DE)
- Job DescriptionAssociate Director , Animal ServicesAbout the JobAnimal Health in Millsboro Delaware seeks to add an Attending Veterinarian in the role of Associate ... Director .This position will have overall responsibility for oversight and...other information as needed for annual reports to Federal regulatory agencies. Leadership for internal and external regulatory… more
- Merck & Co. (Rahway, NJ)
- …to bring analytical representation and expertise to project teams and support regulatory filings (eg, INDs/IMPDs and BLAs).-The Director selects, trains, and ... Job DescriptionThe Director of Biologics Potency in Analytical Research &...be directly responsible for a team of approximately 10-15 senior and associate level scientists in Rahway, New Jersey.… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … regulatory strategy, issues, and risks in written and verbal format to regulatory senior leadership team and other governing bodies required. Travel Ability ... centered around rare diseases and immune disorders. ResponsibilitiesEnsure global regulatory plans support a precision medicine approach eg integrated… more
- Merck & Co. (Rahway, NJ)
- …including budget forecasting and accuracy.Demonstrated ability to successfully negotiate with regulatory agencies and senior operations leaders. Understands the ... Job DescriptionPosition Description: Director , Product Stewardship Our Global Safety & Environment...of our company while driving improvements and alignment for regulatory compliance worldwide.Responsibilities: Manage and provide leadership to a… more
- Merck & Co. (North Wales, PA)
- …& Division organization of our company.- Position Description/Summary: The GPAM Associate Director , Project Manager, is a core member of Early Drug Development ... & Development pipeline and realize its full potential. The Associate Director is expected to provide project management leadership and drive cross-functional… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionWe are currently recruiting for a Director , Global Marketing for Women's Cancer for the oncology portfolio.- The Global Marketing Director will ... marketing execution and budget management.Ensure planning and readiness for senior business and strategy reviews and stakeholder engagement.Engagement with… more
- Novo Nordisk Inc. (Chicago, IL)
- …pricing implications and downstream impact of the evolving public policy, government, regulatory landscape and other relevant trends Identifies and builds a broad ... implications and downstream impact of the evolving public policy, government, regulatory landscape and other relevant trends Continuously identifies and prioritizes… more
- Merck & Co. (Rahway, NJ)
- …and technologies.- They will lead the Technology Integration Meeting and provide Senior Technology approvals in the Design Authority.- They will ensure the smooth ... and overall role administration. This role reports to Executive Director , SAP Platform Team. Primary Responsibilities: Leadership and StrategyProvide strategic… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Key Opinion Leaders (KOLs), Healthcare Professionals (HCPs), and other stakeholders. The Medical Director will also assist the Senior Medical Director in ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...Area in certain instances, at the discretion of Executive Director of Medical Affairs. Assists the Senior … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …opportunity employer including veterans and people with disabilities.SummaryThe Associate Director will be responsible for developing and implementing Clinical ... hands on population PK and PKPD analyses and participate in regulatory interactions and submissions representing the Clinical Pharmacology and Pharmacometrics/… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …this role, the incumbent will help develop multiple products. In doing so, the Senior Medical Director will work across different functional teams to support the ... Are you ready to make a difference?The Position We are seeking an enthusiastic Senior Medical Doctor with a high degree of scientific acumen who is excited by… 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 ... integration of the device development activities with the clinical, regulatory , formulation, commercial and other key company functions.Represent Device Development… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Category Leaders and Managers Scopes out high-profile supplier engagements for senior level executives, develops and negotiates agreements and manages suppliers to ... under adversity Operational mindset and continuous improvement: Considers compliance, regulatory , quality assurance and other requirements when supporting all… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …other members of the Medical Writing team. Relationships The Director Medical Writing ( Director ) reports to a Senior Director of Medical Writing. A key ... the written deliverables that support the clinical development and regulatory requirements of a clinical program. The Director...and global project teams. This role will be a senior member of the Regulatory , Quality and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …with Novo Nordisk policies and procedures. Relationships This position reports to a Senior Director within the Clinical Data Science & Evidence (CDSE) - ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...ready to make a difference? The Position The Associate Director , Research Partnerships (RP) is responsible for developing and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …other research areas centered around rare diseases and immune disorders.Summary The Senior Director sits within Global Oncology Clinical Development, an ... the Target Product Profile (TPP)- Development of clinical sections of trial-level regulatory documents (eg, response to HAs, briefing book, etc.) in conjunction with… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …indication, ie, multiple multinational phase II/III clinical trials; Reviews regulatory documents from cross functional, holistic perspective; Represents clinical ... authorities; Oversees management and performance of CRO. Occasional interactions with CRO senior leadership as needed; Participates in creation of developmental and … more
