- Novo Nordisk Inc. (Plainsboro, NJ)
- …internal and external stakeholders. Relationships This position will report to Senior Director Safety Surveillance, US East Coast Development Hub. Key internal ... new medicines for patients. The Position This leadership role leads the safety surveillance sub-function within the US East Coast Development Hub comprised of… more
- Merck & Co. (North Wales, PA)
- …the necessary processes to ensure high quality individual case and aggregate safety reporting. Interpret PV regulations related to drugs, vaccines, biologics, and ... with all of company's business units to ensure compliance and patient safety .Assist in the development and leadership of team members.Develop and implement… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Clinical Director (Principal Scientist) has primary responsibility for planning and directing clinical research activities involving ... compounds in Immunology. With a focus on late-stage development, the Clinical Director will manage the entire cycle of clinical development, including study design,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Summary The Senior Director sits within Global Oncology Clinical Development, an organization dedicated to ... assessment of protocol deviationsDiscusses medical eligibility questions and answers safety questions (dose modifications, discontinuations, and management of adverse… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders.Summary The Senior Director sits within Global Oncology Clinical Development, an organization dedicated to ... of protocol deviations- Discusses medical eligibility questions and answers safety questions (dose modifications, discontinuations, and management of adverse… more
- Merck & Co. (North Wales, PA)
- …and dedicated colleagues while developing and expanding your career.The Clinical Director (Principal Scientist) has primary responsibility for the planning and ... span all phases of clinical development (pre-clinical to post-licensure). The Director will manage the entire cycle of clinical development, including: study… more
- Merck & Co. (Rahway, NJ)
- …(Non-Sterile) team at the FLEx Center in Rahway is looking for an Associate Director - Process Engineer to lead clinical supply manufacturing, scientific rigor ... person will:Lead and strategically plan on-the-floor batch manufacturing to ensure safety and quality of clinical supplies to augment and accelerate our… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for managing the multiple Clinical Science Asset Leaders (CSALs) at the Senior Director level for each respective program. This Clinical Science (CS) Group Lead will ... charter, etc), clinical data review excellence with a focus on patient safety and data integrity, site scientific engagement, and HA responses. Interactions with… more
- Merck & Co. (Boston, MA)
- …leader to join the Boston Discovery Chemistry Leadership Team as a Director (M3). The successful candidate will be responsible for multidisciplinary portfolio ... support the sustained delivery of a multi-modality portfolio. In addition, the Director will participate in department- and network-wide activities such as resource… more
- Merck & Co. (Rahway, NJ)
- …Critically, the Lead will drive a culture of perpetual adherence to safety and compliance standards. A successful candidate should have GMP facility operations ... skills.The role is based in New Jersey and reports to the Executive Director of FLEx Non-Sterile Operations in Pharmaceutical Operations & Clinical Supply.- Primary… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …in collaboration with the Global Regulatory Leads (GRLs) and Clinical Safety & Pharmacovigilance (CSPV) for assigned products. This position drives/leads the ... Operations and Compliance leads to product high quality labeling documentation.Establishes Process Best Practices: Serve as a role model for less experienced… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …oncology trials as well as submission-related activities, eg, integrated summary of safety (ISS) and integrated summary of efficacy (ISE).- Direct Project Support: ... input to TLF shells for submission documents (eg, ISE and ISS). Develops the process for ensuring that analysis data sets and outputs are compliant with regulatory… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Management, Regulatory Affairs, Quantitative Clinical Pharmacology, Clinical Safety and Pharmacovigilance, Regulatory/Risk Management, Quality Assurance, Medical ... Oversee applications support groups' system validation and change control process . Develop information system roadmaps.Provide such reports that are required… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Management, Regulatory Affairs, Quantitative Clinical Pharmacology, Clinical Safety and Pharmacovigilance, Regulatory/Risk Management, Quality Assurance, Medical ... reviews with technical teams to ensure compliance with standards. Leads in process improvement and develops procedures to improve overall IT systems development with… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …involving 3rd party development. This position partners with GRLs and Clinical Safety Pharmacovigilance (CSPV) leads in the maintenance of Company Core Data Sheets ... in the development of Standard Operating Procedures (SOPs) and process improvements. Follows agreements with external partners.Department Coordination: Builds… 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 ... the Supply Chain business. Relationships Reports to the Senior Director , Supply Chain and is in direct contact with...their level of accountability for results and the measurement process . Ensure that the IDP forms include completed learning… more
- Merck & Co. (Rahway, NJ)
- …portfolio. Within Biologics and Biopharmaceutics, the large molecule product development Director will influence the strategy, lead activities, and develop a team ... whose roles include design and development of formulation, manufacturing process , and primary packaging to enable phase appropriate regulatory filings for large… more
- Merck & Co. (Rahway, NJ)
- …and accelerate process and product development and manufacturing and ensure safety and quality of our products. The successful candidate will be accountable for ... cross-functional development teams to enable pipeline decisions. -The Executive Director , Biologics Analytical Research and Development (B-AR&D) is responsible for… 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 ... their level of accountability for results and the measurement process . Ensure that the IDP forms include completed learning...management and innovation We commit to an inclusive recruitment process and equality of opportunity for all our job… more
- Lovelace Biomedical Research Institute (Albuquerque, NM)
- OverviewReporting to the Senior Director of Facilities & Safety and under limited direction, the Facilities Director will oversee the day-to-day operations ... of the Institute's facilities and physical plant. The Director will play a pivotal role in effectively managing the Facilities Department to ensure a safe and… more
