- Lupin Pharmaceuticals (Coral Springs, FL)
- OverviewThe Respiratory Clinical Development Medical Lead will oversee the clinical and medical aspects of new respiratory medicines, including new drug or ... medical/ clinical queries from health authorities. Leadership and Collaboration: Lead cross-functional teams in clinical development, medical affairs, and… more
- Merck & Co. (Rahway, NJ)
- …function. Proven record in project / portfolio management. Knowledge of Good Manufacturing Practices (GMP) and Good Clinical Practices (GCP) is highly ... internal and external to GCS and serves as the lead GCS spokesperson at clinical and development...systems. Stay updated on industry trends, regulations, and best practices related to clinical supply planning and… more
- Merck & Co. (Rahway, NJ)
- …The position requires the candidate be responsible for the conduct of Good Clinical Practice (GCP) studies, and occasionally Good Laboratory Practice ... and written communicationsProficient in MS Office applicationsUnderstanding of GCP Good Clinical Practices guidelines.Competencies Required: Four years in … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …trained, following process and SOPs. The Director will ensure the Senior Director, Clinical Operations (Asset Lead ) is fully informed of the overall portfolio ... The Director can be an extension to the Asset Lead when needed and serve as an SME (Subject...with their management to share lessons learned and best practices across the Study Management Organization. The Director can… more
- Eisai, Inc (Nutley, NJ)
- …the development of Clinical Protocols to meet CDP objectives.Serves as Study Director/ Clinical Pharmacology Lead and drives the execution of the study from ... 5 years of pharmaceutical industry related experience as a Clinical Pharmacology Project Lead .A thorough understanding of...and as such, is committed in policy and in practice to recruit, hire, train, and promote in all… more
- Eisai, Inc (Atlanta, GA)
- …this is your profile, we want to hear from you. : The Area Business Leader (ABL) will engage with assigned health systems for Eisai's oncology portfolio and manage a ... (S-suite, C-suite, KOLs, Pathway and PandT committee members). Each ABL will lead account responsibility for a defined number of potential strategic accounts and… more
- Merck & Co. (Rahway, NJ)
- …Small Scale Organics (SSO) Pilot Plant is a Good Manufacturing Practices (GMP) facility within the Process Research and Development (PR&D) organization ... enables gain of critical internal experience during scale-up of clinical supplies manufacturing, demonstration of new manufacturing technology/processes, training… more
- Eisai, Inc (Nutley, NJ)
- …and oversight of the Quality management system. This role is responsible for Good Clinical Practice (GCP) and for assuring the compliance of projects, products ... identify, evaluate, and leverage opportunities for advanced analytics, technology/ best practice adoption within clinical quality.Build relations with the… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …functionally with multiple functions and groups throughout the US organization, Clinical Development, Research & Early Development, other affiliates, and the Global ... patients than ever before. The Position The Brand Strategy Lead is pivotal in developing brand level objectives and...with global brand teams to align strategies, share best practices , and adapt global assets for local market needs.… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking QA Investigations Lead III as part of the Quality team based in Raritan, NJ. Role ... OverviewThe QA Investigations Lead is responsible for providing quality oversight over the...production of a personalized cell therapy to support both clinical and commercial requirements in a sterile GMP environment.… more
- Eisai, Inc (Pittsburgh, PA)
- …Eisai, the company and its hhc mission; b) provide key scientific and clinical information about Eisai's products; provide a conduit for communication between Eisai ... and its hhc mission; b) provide key scientific and clinical information about Eisai's products; serve as a conduit...congresses in accordance with MSL plan. Be prepared to lead congress coverage efforts, including coordination of all MSL/Sr.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …standards and practices , SOPs, external/internal data standards, Good Clinical Practices (GCPs), applicable regulatory requirements, and other relevant ... awareness of and disseminates information about emerging trends, best practices , data standards, clinical programming methods, techniques, and… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionOur team in Rahway, New Jersey, is seeking an experienced leader who will manage a team of scientists to support drug substance process development ... high yields along with superior product quality and allow speedy progression for clinical studies and commercial launch. The candidate will be a member of the… more
- Aequor (Thousand Oaks, CA)
- …medicines from lab, to manufacturing plant, to patient. therapeutics have changed the practice of medicine, helping millions of people around the world in the fight ... Cycle Management and Commercial space working with the Operations Leader and the Product Delivery Team. The Sr. PM...stakeholders, the Sr PM will need to understand the Clinical Development Plan and strategy to enable alignment with… more
- Formation Bio (New York, NY)
- …highest standards, including Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), Good Clinical Practices (GCP), Good Pharmacovigilance ... than the industry can progress because of the high cost and time of clinical trials. Recognizing that this development bottleneck may ultimately limit the number of… more
- Eisai, Inc (NJ)
- …looking for a scientifically driven imaging expert with deep knowledge of Oncology clinical trials to shape the future of imaging science across its development ... portfolio. This role offers the opportunity to lead high-impact imaging strategies-from trial design and execution to...strategies, biomarkers, and advanced analytics to support translational and clinical goals. At the same time, they will ensure… more
- Genmab (NJ)
- …strong professional relationships with key customers and stakeholders in private practice , medical group practices , hospitals/academic medical centers, office, ... care of cancer patients. The Senior Oncology Account Manager is a clinical and business leader who represents the values of Genmab by providing approved, disease… 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 ... Process Oversight Manager to oversee all aspects of Good Practice (GxP) documentation management within our organization. This role...Programs, and other CMR Functional areas. This job will lead a team of Patient Safety training and vendor… more
- Merck & Co. (Rahway, NJ)
- …(INDs, IMPDs, NDAs, BLAs, etc.) for combination product programs under your leadership. Lead / Support clinical supplies production with respect to device ... Job DescriptionAre you enthusiastic and driven to create and lead execution of design verification testing strategies for innovative combination products?Join our… more
- Eisai, Inc (Nutley, NJ)
- …launch experience is strongly preferred Knowledge of treatment guidelines, clinical research processes, FDA regulations, pharma regulations/compliant practices , ... and its hhc mission; b) provide key scientific and clinical information about Eisai's products/pipeline; serve as a conduit...congresses in accordance with MSL plan. Be prepared to lead congress coverage efforts, including coordination of all MSL… more
