- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionPosition Description: MCAAS Finance Leadership Development Program Finance at our Company is committed to developing future leaders through its ... Finance Leadership Development Program (FLDP). Individuals are provided...to gain knowledge on products, healthcare systems, payors, and regulatory and reputational risks while working intimately with our… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …deviations and Quality Events, inspection/audit findings, inspection/audit CAPAs).Responsibilities- Leadership / Program oversight : Support the quality ... learned information flow based on read outs from audits, inspections, Quality Events, regulatory intelligence, effectiveness checks on process implementations… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- … program development, and management as they pertain to the IS Quality program .Project Management: Establish and/or maintain IS PMO framework and ... Assurance department and cooperation with various stakeholders to enhance quality and compliance across the organization.Job Responsibilities: Leadership &… more
- Merck & Co. (Rahway, NJ)
- …, Upstream/Downstream Process Development, Formulations, Global Clinical Supply, CMC Regulatory , Quality , and Commercial-facing Partner Groups to support ... a central repository for knowledge and life-cycle management of the program to support regulatory filings.Required Experience and Skills:Extensive experience… more
- Insmed Incorporated (San Diego, CA)
- …a fast paced, collaborative, and multidisciplinary team. This individual will join the Quality Control leadership team. As the QC Stability and Sample Management ... will include, but not necessarily be limited to, the followings:Provide hands-on leadership for the QC Stability and Sample Management operations; management of… more
- Merck & Co. (Rahway, NJ)
- …of integration and partnering for Pharmaceutical development/ CMC with Quality , Regulatory , Operations, Non-clinical, Clinical, and other functional ... candidate:Should have a vision to develop a team, demonstrated leadership skills, biopharmaceutics technical & domain expertise, effective communication skills,… more
- Merck & Co. (Rahway, NJ)
- …multidisciplinary team environment with key stakeholders across the organizations such as Quality , Regulatory CMC, and technical functions, to ensure timebound ... of integration and partnering for Pharmaceutical development/ CMC with Quality , Regulatory , Operations, Non-clinical, Clinical, and other functional… more
- Merck & Co. (North Wales, PA)
- …clinical development planning to ensure that study designs are consistent with program objectives and meet worldwide regulatory and marketing needs.Independently ... art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Quality Management System and GMP Compliance Programs to assure product quality , integrity and compliance with regulatory guidelines and internal/global ... the timely release and delivery of pharmaceutical products as per applicable regulatory standards and company expectations for products. The incumbent is responsible… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and outcomes, addressing potential issues proactively and ensuring adherence to timelines. Program Leadership : Lead and manage multiple research programs, ... cross-functional teams. Present findings and project statuses to cross-functional leadership and alliance management teams.Budget Management: Exhibit strong budget… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Science Asset Leaders (CSALs) at the Senior Director level for each respective program . This Clinical Science (CS) Group Lead will be responsible for overseeing ... multiple program -level CS Asset Leads who are managing a team...CS Group Lead will also ensure the writing of high- quality clinical trial protocols, review of clinical data and… more
- The George Washington University (Washington, DC)
- …compliance with ethical and legal business practices and accreditation/ regulatory /government regulations.Responsibilities Provides strategic leadership and ... expert regulatory guidance to researchers, staff, committee members, and leadership and partners internal and external to the organization. Serves as liaison… more
- Insmed Incorporated (San Diego, CA)
- …operations, toxicology, regulatory affairs, commercial, pharmacovigilance, clinical quality , and biostatistics.Provide medical leadership for key areas ... & interpretation of clinical trial data, authoring clinical study and regulatory communications and documents, and monitoring of competitor activities and data.… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Uses expertise to lead the overall digital content evolution roadmap and portfolio Leadership & Team Management: Lead and develop a team enabling the end-to-end ... and deliverables Stakeholder Engagement & Collaboration: Partners closely with leadership across capabilities and disciplines to ensure that appropriate digital… more
- Merck & Co. (North Wales, PA)
- …art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for ... for late stage drug/vaccine clinical development projects. This may include leadership of one or more projects.-- Accountability predominantly includes the… more
- Merck & Co. (Lower Gwynedd, PA)
- …GxP environment and maintain the highest standards of documentation and quality in accordance with regulatory requirements.Required experience and skills: ... to deep immunological expertise, the candidate will be expected to provide leadership and mentorship to junior staff, build relationships with stakeholders, and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …inclusive of speaker engagement, supporting technologies and overall HCP relations Leadership & Team Management: Set clear goals and expectations, provide regular ... the field systems, conventions and events, and HCP engagement and speaker program teams, aligning their efforts with business objectives and customer experience (CX)… more
- Aequor (Thousand Oaks, CA)
- …Quality Assurance, Process Development, Clinical Process Engineering, Analytical Sciences, Quality Control, Supply Chain, and Regulatory Affairs. Job ... organizations such as Process Development, Process Engineering, Supply Chain, Quality Control, Regulatory Demonstrated technical writing skills Demonstrated… more
