- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …study results as Clinical Study Leader, medical monitor or regional clinical /Translational Medicine and Clinical Pharmacology representativeExternal ... and geographic scope. Such trials could be pivotal for submission; Prepares clinical section of regulatory documents; Oversees management and performance of CRO;… more
- Novo Nordisk Inc. (New York, NY)
- … regional FMA team members to ensure integrated comprehensive coverage of regional clinical and scientific needs Coordinates with key internal stakeholders to ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...regulatory, and compliance requirements Ensures effective administrative management of regional business as well as operational budgets Maintains thorough… more
- Merck & Co. (North Wales, PA)
- …assigned territory. Up to 50% travel required with some overnight.Role Summary The Regional Medical Scientific Director - GI Oncology is a credentialed (ie, PhD, ... from SLs, including questions about Company products. The work of an Regional Medical Scientific Director is aligned to: Scientific Exchange, Research, Scientific… more
- Novo Nordisk Inc. (Minneapolis, MN)
- …prescription benefit plans. Customer channels and specific customers include strategic, regional and local health plans, PBMs, State Government entities and other ... area field account management team at an area level to ensure strategic, regional , state and local account sales objectives via the achievement of profitable access… more
- Catalent (St. Petersburg, FL)
- Supplier Quality Regional Lead Position Summary: Catalent is a global, high-growth, public company, and a leading partner for the pharmaceutical industry in the ... the Global Supplier Quality Management team, the Supplier Quality Regional Lead will be responsible for management and leading...sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more… more
- Merck & Co. (North Wales, PA)
- Job DescriptionActing as Global SME for assigned topics and SOPs, the Global Clinical Development (GCD) Standards & Training Lead (STL) will work closely with ... Quality and Continuous Improvement (QCI), Global Clinical Trial Operations (GCTO), and Global Clinical ...and others.Ensures compliance and alignment with GCD model and regional and local regulations.Collaborates with GCD roles to evaluate… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders.Summary The Clinical Trial Information Disclosure Manager leads company operational activities to ... comply with US, EU, Japan and other regional disclosure regulations and the WHO, IFPMA, and EFPIA-PhRMA...IFPMA, and EFPIA-PhRMA principles. A member of the Global Clinical Trial Disclosure Platform and Operations Committee. Facilitates the… more
- Legend Biotech USA, Inc. (Fort Worth, TX)
- …in the treatment of multiple myeloma. Legend Biotech is seeking Sr. Cell Therapy Clinical Educator - Mid South as part of the Commercial team based in the ... territory. Role Overview The Sr. Cell Therapy Clinical Educator are field based commercial personnel responsible for providing information, education and resources… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …disorders. Summary The incumbent will be responsible for ensuring the delivery execution of clinical studies in one or more geographic regions, in adherence to Good ... Clinical Practices (GCPs), appropriate Standard Operating Procedures (SOPs), Food...execute meetings including Vendor kick-off meetings, study team meetings, regional team meetings, investigator meetings and training. Note that… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and immune disorders.SummaryThe incumbent will be responsible for ensuring execution of clinical studies across geographic regions, in adherence to Good Clinical ... operational planning and execution at the study level with responsibility for clinical study plan and execution (from planning start-up, conduct, reporting and close… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …drug development plan, design, conduct, and interpret Phase 1 (specifically Clinical Pharmacology) studies, support Phase 2/3 studies, represent function on study ... of PK-PD and Pop PK-PD concepts and analysis, phase 1-4 clinical studies, literature, regulatory guidelines, and physiological/pharmacological aspects of the drug.… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …disabilities.SummaryThe Associate Director will be responsible for developing and implementing Clinical Pharmacology and Modeling & Simulation plans from FIH to post ... registration. Responsibilities include the development of Clinical Pharmacology and Modeling and Simulation plans, design and lead study teams to execute Clinical… more
- Daiichi Sankyo, Inc. (Raleigh, NC)
- …Affairs Team.The MSL develops on-going professional relationships with national and regional healthcare opinion leaders and other healthcare professionals to provide ... of qualified 1) investigators and study committee members for DSI clinical research programs, 2) investigator-initiated research study proposals, 3) speakers for… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …for the assigned oncology franchise products, in alignment with key global and regional functions. The Global Director of HEOR & RWE Oncology will lead the ... will be a key and visible expert leader, he/she will engage the clinical , Medical Affairs and commercial organization and drive the product evidence strategies to… more
- Eisai, Inc (Nutley, NJ)
- …will have the primary role of demand generation by conveying complex clinical information to customers and key stakeholders consistent with the FDA-approved ... ethics and compliance standards. Essential Functions Develop and maintain superior clinical expertise with our brand(s) and disease state/conditions to effectively… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …labeling in collaboration with the Global Regulatory Leads (GRLs) and Clinical Safety & Pharmacovigilance (CSPV) for assigned products. This position drives/leads ... Labeling Operations & Compliance group and across the cross-functional and cross- regional representatives on the labeling review teams as well as with business… more
- Eisai, Inc (Nutley, NJ)
- …Business Relationships:Promotes awareness of standards related to security, regulatory, clinical , commercial, and manufacturing processes to establish a culture of ... processes and manage recovery testing.Regularly review adherence to standards.Oversee regional security vendors.Prioritize risk-based reduction efforts.Manager investigations.General Compliance Activities:Maintain… more
- Merck & Co. (North Wales, PA)
- …interface with internal and external stakeholders, including US Medical Affairs, Regional Vaccine Medical Directors, Global Marketing, the Center for Observational ... of the role Preferred Experience and Skills: Ability to translate science/ clinical data into clear marketing strategies, medical education and/or conference… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …solutions. The role involves establishing strong working relationships with the Regional and Local Access leads; alliance partners; and strong collaborations with ... including but not limited to Commercial, Marketing, Medical, & Clinical Development,ResponsibilitiesGlobal Market Access Strategy- Lead the development of pricing,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and drives execution for assigned projects in collaboration with GMA Clinical Operations and other cross-functional and regional stakeholders.Provides support ... local, regional and/or Global level. preferredExcellent knowledge of current clinical practice in Oncology / Hematology / Endocrinology or other relevant disease… more
