- Genmab (NJ)
- …planning, and timely delivery of complete, high quality and reliable clinical trial data . The Associate Director DM will provide oversight to ensure ... and authentic is essential to fulfilling our purpose.The Role:An Associate Director , Data Management is... Management is operationally responsible for the oversight of Clinical Data Management activities related to the… more
- Genmab (NJ)
- …(including clinical trial implementation, and oversight of all aspects of clinical development) working closely with the Medical Director and other ... of the clinical development plan (CDP) Author components with Medical Director and reviewer of clinical and regulatory documents and registration dossiers… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Associate Director of Scientific Nomenclature and Reference Data is responsible for assigning accurate chemical nomenclature to small ... molecules, biologics, and vaccinesBroad understanding of drug discovery, development and research, clinical data coding and experience working within a regulated… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Global Clinical Supply organization is accountable for managing the 'end-to-end' integrated clinical supply chain across the full company ... Research Laboratories portfolio of clinical trials.- Global Clinical Supply is accountable...business risks, & influence portfolio decisions with facts and data Demonstrates ability to balance strategy with ability for… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to ensure appropriate biomarker, PK / PD measurements; Reviews emerging clinical data regularly; Leads dose-escalation meetings; Performs quality assessment ... trial (small size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs.… more
- Merck & Co. (Rahway, NJ)
- …the Quantitative Pharmacology and Pharmacometrics - Immune/Oncology (QP2-IO) team in the role of Associate Director QP2-IO team is part of the Global Clinical ... of drug development and effective communication skills. As a subject matter expert, the Associate Director within the QP2-IO Group will work closely with teams… more
- Merck & Co. (Rahway, NJ)
- …of decision-making at our Company, this position offers an opportunity for the Associate Director to drive pipeline impact across therapy areas.This Associate ... on a continuous basis in decision making and driving pipeline impact. The Associate Director will perform job duties independently with minimal supervision… more
- Genmab (Plainsboro, NJ)
- …our best, and authentic is essential to fulfilling our purpose.The RoleThe Global Clinical Trial Manager (GCTM) is accountable for the end-to-end delivery of a ... single or multiple clinical trials from strategy outline through to CSR by...to IEC/IRB commentsMonitor major protocol deviations (PDs) and trendsApprove data cleaning plansCollaborate with CPL as needed for CST/CDTEstablish… more
- Genmab (Plainsboro, NJ)
- …authentic is essential to fulfilling our purpose.The RoleGenmab is looking for an Associate Director , Global Regulatory Affairs, Regulatory Strategy to be a part ... US RA in the Global Regulatory Team, Labeling Working Groups, Launch Teams, Clinical Trial Teams, and other cross-functional teams as required for the assigned… more
- Merck & Co. (North Wales, PA)
- …strong strategic thinking, ability to comprehend and translate complex scientific & clinical data and deliver results working cross-collaboratively and leading ... organizations and working successfully with cross-functional teamsAbility to translate science/ clinical data into marketing strategies, medical education and/or… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …for a living. Are you ready to make a difference? The Position The Associate Director , Regulatory Affairs - Advertising & Promotion will provide strategic ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …as other research areas centered around rare diseases and immune disorders. Summary The Associate Director of Regulatory Writing is a key role responsible for ... producing scientifically accurate, high-quality clinical regulatory documents while adhering to regulatory guidelines. This...and strategic insights at the study team level. The Associate Director of Regulatory Writing must possess… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …the head of Clinical , medical, Regulatory (CMR) Business Operations, the Associate Director (AD) is responsible for structuring facilitating and monitoring ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...internal stakeholders. In the execution of specific projects, the Associate Director , will be accountable for managing… more
- Merck & Co. (North Wales, PA)
- …that the requirements for the portfolio of pipeline products are clearly articulated. The Associate Director will report directly to the US Marketing Leader for ... the enterprise with colleagues in US Payer Marketing, Global Commercial, Clinical Development, Data & Analytics and Outcomes Research to support the market… more
- Merck & Co. (North Wales, PA)
- Job DescriptionRole SummaryThe Oncology Regional Medical Scientific Director ( Associate RMSD) is a credentialed (ie, PhD, PharmD, DNP, MD) therapeutic and ... policiesMaintains current knowledge and comprehension of dynamic scientific and clinical environment in the Company's Areas of Interest (AOI)ResearchUpon request… more
- Insmed Incorporated (Chicago, IL)
- …and/or product support of appropriate prescribing, improved patient outcomesPresent data on Insmed products to HCPs including physicians, academic institutions, ... knowledge and competency of Insmed therapeutic disease states, products, and competitor data . Serve as a local medical and scientific resource to Insmed for… more
- Genmab (Plainsboro, NJ)
- …best, and authentic is essential to fulfilling our purpose.The Role & DepartmentThe Associate Director , Vendor Management, will play a pivotal role in managing ... the relationships with the clinical vendors as well as coordinate and manage outsourcing...of internal and external stakeholders (eg Scientists, Trial Managers, Data Managers, Clinicians, vendors) to support the overall development… more
- Merck & Co. (Rahway, NJ)
- …portfolio. Within Biologics and Biopharmaceutics, the large molecule product development Director will influence the strategy, lead activities, and develop a team ... opportunity is fast paced and contributes to the Pharmaceutical Sciences and Clinical Supplies (PSCS) deliverable which is the development of robust compositions,… more
- Merck & Co. (Rahway, NJ)
- …build and lead a team of TA dedicated global and regional directors and associate directors. The Executive Director , Value & Implementation (referred to as EDMA) ... Job DescriptionThe Executive Director , Value & Implementation (V&I), Global Medical and...guides TA scientific exchange (input and output) and real-world data generation of all Research & Development (R&D) V&I… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and those involving 3rd party development. This position partners with GRLs and Clinical Safety Pharmacovigilance (CSPV) leads in the maintenance of Company Core ... Data Sheets (CCDS) for assigned products. This position drives/leads...all applicable regulations and guidelines and with Company Core Data Sheets and manages deviations. This position interacts across… more
