- Merck & Co. (Rahway, NJ)
- …in the pharmaceutical industry (eg, Medical Affairs, Regulatory Affairs, Clinical , Pharmacovigilance).- - Required experience and skills: Project management skills ... working a Hybrid work consisting of three total days on- site per week, generally Tuesday, Wednesday and either Monday...or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working… more
- Catalent (St. Petersburg, FL)
- …is responsible for providing leadership and support to the Catalent St. Petersburg site . The Department has the responsibility for Quality aspects related to Quality ... in all applicable areas of the manufacturing operation. The Senior QA Specialist will assist in organizing and prioritizing...when production events occur as defined by SOP and lead cross functional team to classify events and deviations… more
- Merck & Co. (Rahway, NJ)
- …company requirements and regulations are delivered and sustained. The Sr CCQM Lead supports large to medium size country/cluster clinical trial operations to ... collaboration with the Clinical Research Director(s), the Sr CCQM Lead establishes and/or - local...performs QC activities (incl. QCVs) and conducts ad hoc site visits upon request.-On a regular basis and in… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …(FDA) regulations/EU Directive, and International Conference on Harmonization (ICH) guidelines.The Senior Clinical Study Manager will have routine interaction ... in the US and abroad, governmental, academic, community and industry organizations.The Senior Clinical Study Manager role is primarily a tactical study… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Senior Clinical Director ( Sr . Principal Scientist) has primary responsibility for the strategic planning and directing clinical ... involving investigational compounds in Immunology. With a focus on late-stage development, the Senior Clinical Director will manage the entire cycle of … more
- Merck & Co. (North Wales, PA)
- …/scientific execution of clinical protocol(s). This may include:Serving as the lead clinical scientist on a clinical trial team.Leading medical ... the scientific planning and execution of one or more clinical trials or significant aspects thereof. In this position,...working a Hybrid work consisting of three total days on- site per week, generally Tuesday, Wednesday and either Monday… more
- Merck & Co. (Rahway, NJ)
- …including those new to the organization therefore requiring someone who has built and lead clinical development plans from the ground up. They will also be ... development of assets within the Respiratory Section of Global Clinical DevelopmentMay serve as a senior therapeutic...working a Hybrid work consisting of three total days on- site per week, generally Tuesday, Wednesday and either Monday… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …LeadershipHas primary accountability for operational study-level timeline, cost, and quality deliverables. Lead the development of the clinical study plan ... including critical path activities and interdependencies for assigned clinical stud(ies) utilizing Microsoft Project or equivalent. Lead the creation of the cross… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …needs of the overall development plan agreed to by the Global Project Team (GPT). Lead site selection and site qualification discussions, kick-off meetings ... of managing multiple direct reports. ResponsibilitiesOperational StrategyAlign with the Head of Clinical Development Operations or Senior Director, Clinical … more
- Merck & Co. (Rahway, NJ)
- …mission is to serve as PR&D's internal node for small molecule drug substance clinical manufacture, and as preferred site for first pilot of commercial small ... provides a high degree of technical and project management responsibility. The Senior Specialist - Process/Facility Engineering position will report to the Director,… more
- Merck & Co. (North Wales, PA)
- …planning, feasibility, and execution of a clinical trial.May serve as the clinical trial team leadMay lead team in key study planning, development, and ... This position leads the operational planning and execution of one or more clinical trials or significant aspects thereof. In this position, you will have the… more
- Merck & Co. (Rahway, NJ)
- …the role of- Senior Specialist.--QP2-IO team is part of the Global Clinical Development organization and has oversight over drug development aspects related to ... clinical pharmacology and pharmacometrics of oncology drugs from post-Preclinical...in one of the world's most research-intensive biopharmaceutical companies. Senior Specialists in QP2-I/O-will work in collaborative teams with… more
- Merck & Co. (North Wales, PA)
- …Description: Senior Study Manager - Epidemiology OperationsSupport the Lead Epi Scientists by providing overall operational support for study conduct. ... Operating Procedures (SOPs). Manages several complex activities and study types.Our Clinical Research and Pharmacovigilance team push the boundaries of global… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Essential Functions Support the VP Medical/Scientific Development as the US/international clinical lead for DCR-PHXC program to both internally and ... make a difference?The Position We are seeking an enthusiastic Senior Medical Doctor with a high degree of scientific...level Act as a liaison between the company and clinical site investigators and KOLs Interface together… more
- Insmed Incorporated (Bridgewater, NJ)
- …to the VP of Biometrics presents a unique opportunity to establish and lead a team of statisticians to collaborate closely with the Medical Affairs organization ... support in medical affairs activities, collaborating closely with Biometrics senior management and key business stakeholders.Provide leadership, guidance and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …needed- Clinical Development Expertise Strategy- In collaboration with the Global Clinical Lead (GCL), if applicable, leads the development and execution of ... other research areas centered around rare diseases and immune disorders.Summary The Senior Director sits within Global Oncology Clinical Development, an… more
- Insmed Incorporated (Bridgewater, NJ)
- …Best Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Senior Medical Director of Gene Therapy will develop, implement, and lead ... geographic regions ensuring a cohesive approach. This role will develop and lead all medical affairs activities ensuring partnership within the team (medical… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Leaders (CSALs) at the Senior Director level for each respective programThis Clinical Science (CS) Group Lead will be responsible for overseeing multiple ... veterans and people with disabilitiesSummaryThis position will be the Clinical Science Group Lead in late phase...with a focus on patient safety and data integrity, site scientific engagement, and HA responsesInteractions with the internal… more
- Merck & Co. (North Wales, PA)
- …activities. This position, under the supervision of a Research Management Team Lead , will execute a variety of research management activities starting from study ... Outcomes Research, V&I GMSA, BARDS HEDS, and others as determined by senior leadership by providing overall operational support for research conducted in compliance… more
- Insmed Incorporated (Bridgewater, NJ)
- …will possess a deep understanding of the pharmaceutical development process from pre- clinical development through life-cycle management and be willing to engage with ... techniques in support of preclinical stage small molecule research projects. Lead activities related to analytical testing and method qualification, including… more
