- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders. Summary The Manager, Regulatory Affairs - Regulatory Project Management (RPM) provides ... The Manager RPM is responsible for supporting the global regulatory lead (GRL), US regulatory ...preparing agenda and tracking action itemsResponsible for maintaining global health authority query (HAQ) tracker and archiving regulatory… more
- Merck & Co. (Rahway, NJ)
- … regulatory , quality, company, and customer requirements.-This position will lead cross-functional development teams within and external to Device Development. ... product programs under your leadership.Remain current in relevant worldwide regulatory guidance and standards. Lead /support/oversee clinical supplies production… more
- Merck & Co. (North Wales, PA)
- …Hands-on experience in the conduct and execution of regulatory digital health assessments Development of critical analysis and project management skills- ... sessions, and receive direction from our Veteran Talent Program Lead throughout the Fellowship. Our primary objective is to...join us-and start making your impact today. -Overview: The Regulatory Digital Health (RDH) department engages with… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …to ensure timely and high-quality regulatory deliverables to the GPTs Lead health authority interactions, including leading team through creation of briefing ... new medicines for patients. We recognize that improving human health starts here and that patients rely on us....wants to work with innovative investigational medicines. You will lead a global regulatory team to develop… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …This position serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational leadership on product ... labeling in collaboration with Global Regulatory Leads (GRLs). This position may serve as an...may serve as an ad hoc member of Global Project Team (GPT) to address labeling issues for late… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …preferred. Experience Qualifications:4 or More Years of proven experience in a regional regulatory lead role7 or More Years of relevant pharmaceutical experience ... regulatory strategy for assigned development projects. Represents Daiichi Sankyo's regulatory group in internal and external development project meetings.… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …the most diverse and collaborative groups within the organization. From health -care-provider interactions and developing and implementing regulatory strategies ... About the Department The Clinical Development, Medical and Regulatory (CMR) department at Novo Nordisk is one...project management. Pharma experience preferred Demonstrated ability to lead and work within a cross functional team; ability… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …trial protocols, review of clinical data and Clinical Study Reports (CSRs)/outputs throughout the project life cycle. The CS lead will also contribute to the ... immune disorders. Summary This position is a Clinical Science lead position and will lead a group...for the function. As a member of the Global Project Team (GPT), the incumbent closely collaborates with the… more
- Merck & Co. (North Wales, PA)
- …patients who need it most. Invent. Impact. Inspire.Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and ... animal health products. The difference between potential and achievement lies...features small groups encompassing all disciplines to drive each project with greater precision and purpose. Our goal- to… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …primary responsibilities of this position are to guide the strategy and to lead the implementation of companion diagnostics (CDx) in support of projects within ... for patients who are likely to benefit from our therapeutics.ResponsibilitiesLeads CDx project teams for the diagnostic, in full alignment with Global Program Teams… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …of both worlds to develop new medicines for patients. We recognize that improving human health starts here and that patients rely on us. We're changing lives for a ... teams. Motivated, collaborative, and science-driven global safety expert who would lead the ongoing assessment of safety profile of assigned molecules/products and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …the most diverse and collaborative groups within the organization. From health -care-provider interactions and developing and implementing regulatory strategies ... About the Department The Clinical Development, Medical and Regulatory (CMR) department at Novo Nordisk is one...and effectiveness to build capability in function. Essential Functions Project Management: Lead initiatives related to digital… more
- Eisai, Inc (Nutley, NJ)
- …healthcare provides to patients, their families, and caregivers is Eisai's human health care (hhc) mission. We're a growing pharmaceutical company that is breaking ... play a pivotal role in ensuring the organization's adherence to security, regulatory , and compliance standards. Collaborating with business and EIT stakeholders, you… more
- Merck & Co. (Durham, NC)
- Job DescriptionThe Lead Maintenance Technician is a leader with strong interpersonal, communication, and collaboration skills responsible for leads peers in ... supporting the manufacturing process. Individual will possess the ability to lead a team, train others and contribute to and implement process improvements. The … 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 ... function at meetings with health authorities; Oversees management and performance of CRO. Occasional...leadership as needed; Participates in creation of developmental and regulatory strategy in collaboration with Regulatory Affairs;… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …manage a team of Global Labeling Leads (GLLs) and/or serve as the Labeling Project Lead . This position leads labeling meetings for preparation of responses to ... and immune disorders. SummaryThis position serves as the Global Regulatory Affairs (GRA) Labeling Strategy expert to the Global...Core Data Sheets, EU and US Documentation: As the project lead , Independently or through direction of… more
- Merck & Co. (North Wales, PA)
- …and global human health . Responsibilities :Serves as a statistical lead in project teams.Develops, coordinates, and provides biostatistical leadership and ... written reports to effectively communicate results of clinical trials to the project team, our company's Management, regulatory agencies, or individual… more
- Merck & Co. (Durham, NC)
- …for complex process, validation, analytical, equipment, facility/utility and/or automation changes. Lead validation topics in regulatory inspections by presenting ... of 6 scientists and engineers and must demonstrate strong technical and project management skills. The individual must embrace an empowered team culture.Our… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … on Component teams and/or serve as G-RACMC lead or regional submission lead . Provide regulatory guidance and strategy to CMC sub-team and G-RA teams along ... disorders.Summary The Associate Director, RACMC, is responsible for the regulatory CMC (Chemistry, Manufacturing and Controls) activities from early development… more
- Insmed Incorporated (Bridgewater, NJ)
- …15 years of experience as a regulatory toxicologist (study director/monitor and/or project lead ) in the pharmaceutical or biotechnology industry or within a ... Mechanisms. In this role, you will represent toxicology at cross-functional project teams, strategize nonclinical safety data package, oversee safety pharmacology… more
