- Merck & Co. (North Wales, PA)
- Job Description Position Description: Associate Director , Regulatory Affairs Liaison- Vaccines and Infectious Disease The Regulatory Affairs Headquarters Associate ... regulatory strategy as needed to colleagues in Regulatory Operations, Clinical Safety , Labeling, Regulatory Chemistry, Manufacturing and Control (CMC) as well as… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …innovation with facilities in Lexington, MA and Plainsboro, NJ. We support programs from early research through late-stage clinical development. We are building for ... incumbent will help develop multiple products. In doing so, the Senior Medical Director will work across different functional teams to support the design and… more
- Insmed Incorporated (Bridgewater, NJ)
- …lists.OverviewOverview The Director , Toxicology, is a key member of the nonclinical safety team, reporting to the Executive Director , Head of Toxicology and ... you will represent toxicology at cross-functional project teams, strategize nonclinical safety data package, oversee safety pharmacology and toxicology studies,… more
- Eisai, Inc (NJ)
- …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 and ... communication/publication components of overall medical operating plan. The Medical Director provides strategic development, planning, implementation and oversight of… more
- Merck & Co. (Rahway, NJ)
- …a high degree of technical and project management responsibility. The Associate Director - Process/Facility Engineering position will report to the Director , ... include the following:The process/facility engineer role at the Associate Director level will serve as a technical mentor and...and are continuing to be upgraded to support pipeline programs such as ADCs, PDCs, and other cross modality… more
- Eisai, Inc (Nutley, NJ)
- …your profile, we want to hear from you. Job Summary The Medical Director will provide medical leadership for medical affairs strategy, planning and supportive ... therapeutic area. Under the direction of the Senior Medical Director , this role will be responsible for working with...planning, implementation and oversight of Phase IV clinical trial programs within the Medical Affairs department for products in… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders. Summary The Senior Director , Head Global PV Quality (DSI/DSE) reports to the Global Head RDPVQA, ... function and collaborate with RD and Medical Affairs Quality to provide clinical safety QA advise wherever necessary. Ensure requirements are in place for quality… more
- Merck & Co. (Rahway, NJ)
- …enable and accelerate process and product development and manufacturing and ensure safety and quality of our products. -The successful candidate will be accountable ... with cross-functional development teams to enable pipeline decisions.- The Director , Biologics Analytical Research and Development (B-AR&D) is responsible for… more
- Merck & Co. (Rahway, NJ)
- …as needed. The position is also responsible for implementing actions to meet Safety and Environment (S&E) and GMP requirements as well as ensuring facility readiness ... pilot plant. The Facility Lead position reports to the Director of Operations/Head of SSO Pilot Plant and the...of GMP documentation. Support compliance with Industrial Hygiene (IH) program by leading or participating in IH sampling activities… more
- Merck & Co. (Durham, NC)
- …people that make our products. We work in the manufacturing plants with a " Safety First, Quality Always" mindset striving for continuous improvement. We work in the ... the world have enacted new or expanded HPV vaccination programs , which has created an unprecedented increase in global...substance manufacturing facility. As a direct report to the Director of Operations, the Associate Director will… more
- Merck & Co. (Rahway, NJ)
- …to the world.Looking for someone with a growth mindset. The Director , Regulatory Affairs Liaison is responsible for:Developing regulatory strategy for their ... contact on those projects.Functions as first liaison assigned to programs where the compound is first-in-class or is in...our company; where no regulatory guidance exists; where the program is extremely accelerated; is an Alliance program… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …clinical trial performance and quality metrics and share with study team, Operations Program Lead, and Sr. Director for the compound, on regular basis ... Directive, and International Conference on Harmonization (ICH) guidelines. The Associate Director is accountable for operational planning and execution at the study… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …events based upon approved Safety Management Team (SMT) materials- Supports overall program safety reporting (eg, Periodic Safety Update Reports (PSURs), ... areas centered around rare diseases and immune disorders.Summary The Senior Director sits within Global Oncology Clinical Development, an organization dedicated to… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …future capabilities. We're responsible for regulating accounting, upholding workplace safety , managing our supply chain and sampling, supporting technological and ... date with the latest methodologies and insights. Relationships Reports to the SR Director Sales Reporting & GtN. Internal relationships include Senior HQ & local… 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 ... be responsible for overseeing multiple program -level CS Asset Leads who are managing a team...clinical data review excellence with a focus on patient safety and data integrity, site scientific engagement, and HA… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …future capabilities. We're responsible for regulating accounting, upholding workplace safety , managing our supply chain and sampling, supporting technological and ... for the development and execution of data strategies for patient support program use cases and patient case management analytics, focusing on optimizing patient… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …the development and implementation of Research & Development (R&D) informatics systems and programs to support the business functions of Daiichi Sankyo (DS) in the ... and Data Management, Regulatory Affairs, Quantitative Clinical Pharmacology, Clinical Safety and Pharmacovigilance, Regulatory/Risk Management, Quality Assurance, Medical Affairs,… more
- Catalent (Philadelphia, PA)
- Position: Director QualityLocation: Philadelphia, PAPosition Summary: The Quality function is to build, monitor, and sustain a robust and effective quality system ... and Australian agencies and other international and/or local health authorities.The Director of Quality is responsible for providing leadership and Quality… more
- Insmed Incorporated (Bridgewater, NJ)
- …Best Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Director , Clinical Development will play an important role in working with the ... on all the clinical aspects of the upcoming HS program . Strong leadership skills are a must for this...blinded data reviews.Production of tables, listings and narratives of safety areas of interest/focus: eg MACE, Potential events related… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …study; Consults with KOLS for advice on complex development or safety issuesScientific, Program related: Integrated Study Team (IST) representative ... and immune disorders.SummaryOversees a number of trials of a multinational program in a specific indication, ie, multiple multinational phase II/III clinical… more
