- Daiichi Sankyo, Inc. (Bernards, NJ)
- …working with contract manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub team and the RA ... team and serves as ad hoc member to the Global Project Team for late stage projects. This position manages multiple biological developmental projects with supervision, including working with contract manufacturing organizations CMO. This position develops… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …CDx development : Provide critical strategic and tactical regulatory guidance for CDx/IVD development and CDx submission plan for each country/region, both before and ... Join a Legacy of Innovation 125 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …around rare diseases and immune disorders. JOB SUMMARYThe Senior Director, Head Medical affairs Quality Assurance in Global RD/PV QA is accountable to drive the ... strategy and quality plan closely aligned with the Global Oncology Medical Affairs (GOMA), Oncology Business Unit (OBU) and Specialty Business Unit (SBU) Medical… more
- Genmab (NJ)
- …like a fit? Then we would love to have you join us!The RoleThe Associate Director, External Data Quality Management, is a strategic leadership role within Clinical ... for inspection readiness, regulatory compliance, and successful data submissions.The Associate Director will lead cross-functional collaboration, provide oversight of… more
- Merck & Co. (North Wales, PA)
- Job DescriptionRole SummaryUnder the guidance of a senior leader, an Associate Principal Scientist/ Associate Director, has primary responsibility for ... is expected to work cross-functionally with clinical development, medical affairs , biostatistics, market access, commercial and country affiliates. The incumbent… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …sales, medical/CMR, legal, compliance, and regulatory. Other internal relationships include Public Affairs , Government Affairs & US Corp Giving & Social Impact. ... External relationships include relations with patient/caregiver consultants and, key opinion leaders (KOLs), professional organizations, customers and patient support service providers and organizations. Essential Functions Oversee day-to-day pharmacy… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionJOB DESCRIPTION SUMMARYThe Associate Principal Scientist is a DVM/VMD and/or PhD whose primary function is to design, coordinate, monitor, and report ... Practice (GCP) studies, and occasionally Good Laboratory Practice (GLP) studies.The Associate Principal Scientist is the primary clinical study team leader and… more
- Legend Biotech USA, Inc. (Chicago, IL)
- Legend Biotech is seeking a Regional Key Customer Marketing (Central) Associate Director as part of the Commercial team based in (but not limited to) AZ, IL, or TX. ... Leadership, in addition to home office-based colleagues in Marketing, Medical Affairs , Sales, and Market Access.The behaviors that are critical for success… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …globally with Formulation and Analytical Scientists, Clinical Operations, Regulatory Affairs CMC, and Clinical Development to collate the necessary information ... to author the Dose Preparation Instructions and address questions from the clinical sites. The candidate will optimize and continuously improve the Pharmacy Manual (PM) template with inputs from internal and external stakeholders. Collaboration with external… more
- Genmab (NJ)
- …with key stakeholders within Global Development Operations (GDO), Medical Affairs , Medical, and/or CROs, to enable expedited, predictive delivery for ... all stages of global feasibility. Ensure standardization in use of data, tools and processes to inform risk-benefit decision making at TA, program and study levels.This position reports to our Princeton, NJ office and is… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to ensure successful implementation of CDx and data collection Supports Regulatory affairs in providing content and providing review of documents supporting CDx ... submissions to the FDA and other health authorities globally For late-stage programs, executes the Diagnostic development strategy for a project under the direction of the GPT CDx representative while keeping abreast of regulatory and policy updates in the… more
- AUROBINDO (Dayton, OH)
- …expertise in manufacturing, R&D, Quality Assurance and Quality control and regulatory affairs . In addition to several formulations under manufacture, we have a ... make this a healthier world to live in.Job OverviewIPQA Associate Level I will support and assist the day...Operating Procedures (SOPs) and batch record specification. The IPQA Associate Level I shall assure compliance with all standards… more
- Merck & Co. (North Wales, PA)
- …the way we approach serious diseases. --The Senior Director will report to an Associate Vice President in the Oncology Clinical Research Group. Under the guidance of ... closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development projects; and… more
- Merck & Co. (Rahway, NJ)
- …Reporting to the Customs & International Trade (CIT) Valuation Associate Director, the Senior Specialist position's core responsibilities are to ... Project Management Information Systems (PMIS), Project Risk Assessments, Regulatory Affairs Management, Regulatory Reporting, Regulatory Training, SAP Global Trade… more
- Merck & Co. (Rahway, NJ)
- …DescriptionReporting to the Customs & International Trade (CIT) Tariff Classification Associate Director, the Senior Specialist will work closely with our Research ... Solving, Process Improvements, Project Management, Project Risk Assessments, Regulatory Affairs Management, Regulatory Reporting, Regulatory Training, SAP Global Trade… more
- Merck & Co. (Rahway, NJ)
- …closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development projects; and ... assist the Executive Director and/or Associate Vice President in ensuring that appropriate Corporate personnel are informed of the progress of studies of our company… more
- Merck & Co. (Boston, MA)
- …closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development projects, and ... assist the Associate Vice President and/or Vice President in ensuring that appropriate Corporate personnel are informed of the progress of studies of our company and… more
- Beckman Coulter Diagnostics (Miami, FL)
- …that address the world's biggest health challenges. The Senior Clinical Research Associate for Beckman Coulter Diagnostics is responsible for monitoring the in-house ... part of the Clinical Chemistry and Immunoassay (CCIA) Clinical Affairs Department located in Chaska, MN and will be...time.You will be a part of the CCIA Clinical Affairs Team and report to the Clinical Affairs… more
- Commonwealth of Pennsylvania (PA)
- Federal Affairs Associate , Governor's Office - Washington DC Print (https://www.governmentjobs.com/careers/pabureau/jobs/newprint/4951315) Apply Federal ... Affairs Associate , Governor's Office - Washington DC Salary $75,000.00 - $95,000.00 Annually Location *Out of State, PA Job Type Non-Civil Service Permanent… more
- PLUS Communications (Arlington, VA)
- …and media buying. PLUS means more! PLUS Communications is looking for a Public Affairs , Associate to play an important role in executing communications plans - ... development. The role functions across a variety of public affairs accounts and policy areas with a heavy focus...(ie digital, print, social, broadcast). + Interest in public affairs and policy issues; ability to synthesize technical content.… more
