- Merck & Co. (Rahway, NJ)
- …teams and the operational/executional arms within the business.-- - - The Program Clinical Supplies Project Manager (Program CSPM) serves as the primary ... ( as a lead GCS Planning program representative ) such as clinical development, regulatory , quality and other supply chain areas to negotiate timelines ,-… more
- Merck & Co. (Rahway, NJ)
- …operational/executional arms within the business.-- - - Working independently, the Protocol Clinical Supplies Project Manager ( Protocol CSPM) designs strategic ... supplies . - Interacts with key partner organizations such as clinical development, regulatory , quality and other supply chain areas to address clinical … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …well as other research areas centered around rare diseases and immune disordersJob Summary: The Regulatory Process Manager will be a key member of the Global ... Regulatory Affairs (GRA) Process Excellence & Analytics function, responsible...Regulatory Affairs and cross-functional teams (eg, Quality, CSPV, Clinical Operations, Clinical Development, RA CMC) to… more
- Merck & Co. (Rahway, NJ)
- …mentorship to other clinical scientists.Core Skills Solid knowledge of clinical research regulatory requirements (eg, GCP and ICH)Ability to manage ... SummaryThis position leads the scientific planning and execution of one or more clinical trials or significant aspects thereof. In this position, you will have the… more
- Merck & Co. (Rahway, NJ)
- …tactical/scientific mentorship to other clinical scientists. Core Skills Solid knowledge of clinical research regulatory requirements (e . g . , GCP and ICH) ... scientific -pl anning and execution of one or more clinical trials or significant aspects thereof . In this.... , ICF documents/ amendments); Partners with the Study Manager on study deliverables. Ensuring CRF design supports data… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Interactions: Leads US FDA/EU EMA interactions with support from higher-level manager . Regulatory Knowledge: Demonstrates expert knowledge of US/EU regulatory ... working with contract manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub team and… more
- Merck & Co. (North Wales, PA)
- …managing any study specific partners and/or vendors.Core Skills: Solid knowledge of clinical research regulatory requirements (eg, GCP and ICH)Ability to manage ... DescriptionThis position leads the operational planning and execution of one or more clinical trials or significant aspects thereof. In this position, you will have… more
- Merck & Co. (North Wales, PA)
- …and key strategic engagements. This includes the ability to:--Strong knowledge of clinical research regulatory requirements (eg, GCP and ICH) Proven ability ... the strategy and leads the operational planning and execution of one or more clinical trials. In this position, you will have the opportunity to demonstrate your… more
- Genmab (NJ)
- …fit? Then we would love to have you join us!The Role:The Senior Statistical Manager acts as a biostatistician supporting the clinical development of compounds as ... methodologies that may support innovation and improve efficienciesEngage with regulatory authorities on compound/indication level discussionsActs as a role… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Pharmaceutical industry, with involvement in regulated clinical trials, clinical safety, pharmacovigilance included regulatory document reviewMust have at ... least 4 or more years proficiency in ICH GCP Guidelines, US and European regulatory requirements for the conduct of clinical trials and creation of regulatory… more
- Lundbeck (Edmond, OK)
- …transform lives. Join us on our journey of growth! As a Psychiatry Account Manager , you lead the promotion of our psychiatry portfolio, executing sales and marketing ... strategies with comprehensive clinical knowledge to drive sales performance. Our Account Managers are adept at executing against the toughest commercialization… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …with key stakeholders within CSPV and external functions including Clinical Development, Research Development, Regulatory Affairs.Facilitate operational meetings ... language in associated contractual templates. Ensures Good Pharmacovigilance Practice and regulatory compliance in such arrangements. Contribute to the management of… more
- Genmab (NJ)
- …Writing Manager to help us tell the story of our science through compelling clinical and regulatory documents. You'll be at the heart of a team that plays ... Global Medical Writing team, you will drive the development of high-quality clinical documents to support operational, medical, and regulatory activities across… more
- BioAgilytix (San Diego, CA)
- …you enable life-changing, life-saving therapeutics to the patients who need them.The Manager II will lead scientific and operational activities in support of ... preclinical, clinical , and product release studies for our San Diego...reports and prepare SOPs.Fulfill the role of Bioanalytical Project Manager (BPM)/Principal Investigator (PI) for all assigned clients and… more
- Genmab (NJ)
- …like a fit? Then we would love to have you join us!The Programming Manager supports the development of new therapies by ensuring integrity, consistency and adherence ... the programming efforts of at least one study are in scope.The Programming Manager will support the Data Management, Statistics, Drug Safety, Medical, Clinical … more
- Lundbeck (Raleigh, NC)
- …to stakeholders in the primary care and neurology settings. As an Account Manager , you lead the promotion of our psychiatry portfolio, executing sales and marketing ... strategies with comprehensive clinical knowledge to drive sales performance. Our Account Managers are adept at executing against the toughest commercialization… more
- Genmab (NJ)
- …us!The RoleThe Associate Director acts as a statistical expert supporting the clinical development of compounds as compound and/or indication lead for both early ... responsibilities as described below. The Associate Director contributes to clinical development strategies and plans.Responsibilities:Compound/Indication LevelAct as lead and… more
- Merck & Co. (North Wales, PA)
- …Vice President in BARDS and will work collaboratively with other leaders in Clinical Development and Global Regulatory Affairs.--The AVP provides leadership and ... art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for… more
- BioAgilytix (San Diego, CA)
- …departments. This role oversees daily laboratory operations, scientific quality, and regulatory compliance across both functions, supervising up to 40 employees.The ... studies in biological matrices using LC-MS/MS, supporting preclinical and clinical development across multiple modalities. The remaining 5% will involve… more
- Johns Hopkins Medicine (Baltimore, MD)
- …recruitment and training, and ensuring high-quality patient care across various clinical settings: inpatient units and intensive care units. Key Responsibilities: ... initiatives. Monitor budgetary goals, equipment updates, and compliance with regulatory standards. Collaborate with multidisciplinary teams to achieve institutional… more
