- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …well as other research areas centered around rare diseases and immune disorders.SummaryThe Associate Director , Regulatory Operations - Dossier Planning ... INDs, original and supplemental NDAs/BLAs/MAAs. The Associate Director partners with the Head of Regulatory ... Director partners with the Head of Regulatory Operations in developing processes and standards… more
- Merck & Co. (Rahway, NJ)
- …include, but are not limited to:Reports to Executive Director or Associate Vice President, General MedicineDevelops worldwide product regulatory strategy to ... for someone with a growth mindset.Position Description: The Senior Director , Global Regulatory Lead, is responsible for...your employment may pose an undue burden to business operations , in which case you may not be offered… 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
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …This position serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational leadership on product ... labeling in collaboration with Global Regulatory Leads (GRLs). This position may serve as an...and tracking of labeling milestones. Collaborates with Global Labeling Operations and Compliance Leads to produce high quality labeling… more
- Merck & Co. (Rahway, NJ)
- …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
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …other research areas centered around rare diseases and immune disorders.Summary The Associate Director , Global Clinical Operations (GCO) Procedural Ownership ... policies, and meet applicable ICH and GCP standards. The Associate Director will also be responsible for...experience in one or more key functions (eg clinical operations , clinical research, clinical science, and/or CQA). Strong experience… more
- Merck & Co. (Rahway, NJ)
- …to bring analytical representation and expertise to project teams and support regulatory filings (eg, INDs/IMPDs and BLAs).-The Director selects, trains, and ... Job DescriptionThe Director of Biologics Potency in Analytical Research &...responsible for a team of approximately 10-15 senior and associate level scientists in Rahway, New Jersey. -The position… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …centered around rare diseases and immune disorders.Summary The Associate Director , RACMC, is responsible for the regulatory CMC (Chemistry, Manufacturing ... on Component teams and/or serve as G-RACMC lead or regional submission lead. Provide regulatory guidance and strategy to CMC sub-team and G-RA teams along with other… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …collaborating closely with Translational Science Leads, Clinical Biomarker Leads, Biosample Operations , Clinical Leads and Regulatory Liaisons to ensure ... successful implementation of CDx and data collectionSupports Regulatory affairs in providing content and providing review of...of the GPT CDx representative while keeping abreast of regulatory and policy updates in the external environment and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …with key roles in Global DX / GDO / GCO / BDM / RD Finance/ CSPV/ Regulatory Operations / QA to ensure optimal definition and adoption of metrics. Act as a ... with one or more clinical systems like CTMS, EDC, eTMF, Planisware, Product Registry, Regulatory etc. required4 or More Years Experience in working with CRO data for… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …as other research areas centered around rare diseases and immune disorders. **Summary** The Associate Director , Regulatory Operations - Dossier Planning ... INDs, original and supplemental NDAs/BLAs/MAAs. The Associate Director partners with the Head of Regulatory ... Director partners with the Head of Regulatory Operations in developing processes and standards… more
- Publicis Groupe (New York, NY)
- …company with the stability and experience of a global leader. **Job Description** The Director of Regulatory Operations is responsible for ensuring the ... making hiring decisions, overseeing onboarding, and fostering career development. The Director partners with clients to uncover, document, or improve Medical, Legal,… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …This position serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational leadership on product ... labeling in collaboration with Global Regulatory Leads (GRLs). This position may serve as an...and tracking of labeling milestones. Collaborates with Global Labeling Operations and Compliance Leads to produce high quality labeling… more
- Merck (Rahway, NJ)
- …Looking for someone with a growth mindset. **Position Description:** The Senior Director , Global Regulatory Lead, is responsible for development and ... **Job Description** Our Regulatory Affairs team bring new medical advancements to...but are not limited to:** + Reports to Executive Director or Associate Vice President, General Medicine… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …the budget through the lifecycle of the program by communicating changes to TA Operations Leader or Director POL, as appropriate + Ensure timely delivery of ... The Program Operations Leader (POL) is responsible for leadership, implementation...program lifecycle and is the cross functional leader for Regulatory Authority Inspections + Responsible for CTM resource forecasting… more
- New Jersey Institute of Technology (Newark, NJ)
- Title: Associate Director of Health and Safety Department: Office of the Dean - NCE Reports To: Dean, Newark College of Engineering Position Type: Staff Position ... Summary: The NCE Associate Director of Health and Safety works...of facilities and staffing to ensure safe and compliant operations . S/he maintains contacts with regulatory agencies,… more
- Publicis Groupe (New York, NY)
- …www.facebook.com/digitashealth | Twitter: www.twitter.com/digitas_health **Job Description** The Senior Associate , Regulatory Review must follow the protocol ... materials for regulatory review. You'll report to the Manager, Regulatory Review or the Director , Regulatory Review This is a hybrid role, requiring… more
- Teva Pharmaceuticals (Parsippany, NJ)
- Associate Director , New Product Strategy - Parsippany, NJ Date: Jun 11, 2024 Location: Parsippany, United States, New Jersey, 07054 Company: Teva Pharmaceuticals ... launches that come from our in-house development and 3rd party partners. As an Associate Director , New Product Strategy your challenge is to manage the generic… more
- RiseBoro Homecare Inc. (Brooklyn, NY)
- ESSENTIAL DUTIES AND RESPONSIBILITIES The Associate Director , Home Delivered Meals is a member of the management team that coordinates services for the Home ... Director of the Home Delivered Meals Program. The Associate Director is responsible for managing a...and providing guidance and support to the meal delivery operations team (fleet management, driving, and delivery staff) and… more
- Scotiabank (New York, NY)
- Associate Director , US Structuring & Execution, Lev Fin **Requisition ID:** 201590 **Salary Range:** 185,000.00 - 185,000.00 _Please note that the Salary Range ... committed to results, in an inclusive and high-performing culture. **Title: Associate Director , US Non-Investment Grade Execution and Structuring-US Corporate… more
