- Daiichi Sankyo, Inc. (Bernards, NJ)
- …centered around rare diseases and immune disorders. Summary: Responsibility for regulatory strategy to support the development of biomarkers, companion diagnostic ... products.Responsibilities: CDx development : Provide critical strategic and tactical regulatory guidance for CDx/IVD development and CDx submission plan for… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other research areas centered around rare diseases and immune disorders. Summary: The Associate Director , Laboratory Data Management is accountable for the ... technology, and standards. This position ensures quality delivery of laboratory data for clinical trials, clinical development, and regulatory submissions.… more
- Eisai, Inc (Exton, PA)
- …Quality Control, Regulatory , and CMC Program Management departments.The Associate Director of Biologics Operations maintains knowledge of established ... is your profile, we want to hear from you.The Associate Director of Biologics Operations Upstream and...close-out reports for Biologics Pilot Plant campaigns. Support providing data for regulatory documents as required.7. Ensure… more
- Merck & Co. (San Francisco, CA)
- …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
- Merck & Co. (San Francisco, CA)
- …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. (North Wales, PA)
- Job DescriptionRole SummaryUnder the guidance of a senior leader, an Associate Principal Scientist/ Associate Director , has primary responsibility for ... reimbursement and market access, and provide input into clinical, regulatory , payer/access, marketing and evidence generation strategy and programsIn collaboration… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionAbout the Role:-As a Technical Lead, you will report into Director , Chemical Technical Operations, External Manufacturing API Technology, and play a ... Review process change requests and deviation reports while ensuring regulatory compliance. Education and Minimum Requirements:Bachelor's degree in engineering,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …design pull you in? Are you ready to experiment with us? The Position The Associate Director - Launch Operations will play a pivotal role in guiding the ... strategy, focusing on every touchpoint that impacts our customers. We leverage data and insights to inform our decision-making processes, ensuring that our… more
- Merck & Co. (Rahway, NJ)
- …(as a lead GCS Planning program representative) such as clinical development, regulatory , quality and other supply chain areas to negotiate timelines,- strategies ... both technical & business risks, & influence portfolio decisions with facts and data Demonstrates ability to balance strategy with ability for tactical execution and… more
- Merck & Co. (Durham, NC)
- …Manufacturing Operations, Drug Delivery Systems and Devices within our Manufacturing Division ( Associate Director ).-This role serves as a Virtual Plant Manager - ... contact for all dealings between our Company and the External Partner, the Associate Director External Manufacturing Operations is accountable for establishing a… more
- Merck & Co. (Rahway, NJ)
- …West Point, PA / Rahway, NJ is seeking a curious and collaborative Associate Director to support our rapidly expanding cardiometabolic and ophthalmology ... pipelines. - As an Associate Director , you will represent QP2 on...design, protocol development, study execution, reporting and interpretation of data . Maintain a comprehensive understanding of global regulatory… more
- Merck & Co. (Millsboro, DE)
- Job DescriptionOur company seeks to add an Associate Director . Veterinarian Services at our Millsboro, Delaware location. This position will have overall ... (USDA, DEA, DNREC, etc.) of animal facilities and program reviews is required.PurposeThis Associate Director will report to the Site Quality Head/ Director … more
- Eisai, Inc (Nutley, NJ)
- …on GCP and current regulations for those undertaking clinical studies.Job SummaryThe Associate Director , GCP Quality Assurance works within the Global Clinical ... Completes audits to assess accuracy and quality of scientific data submitted to the regulatory agencies in...25%)Eisai Salary Transparency Language:The base salary range for the Associate Director , Clinical Quality Assurance is from… more
- Genmab (NJ)
- …Advances this effort through the coordination and development of data -driven early indication and program assessments, study-level feasibility assessments, robust ... delivery for all stages of global feasibility. Ensure standardization in use of data , tools and processes to inform risk-benefit decision making at TA, program and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs. Drafts development plans, ... Teams.Responsibilities: Study Strategy: Provides the strategic direction to Biostatistics Data Management & Data Ops for EDC, edit checks, data quality… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and associated data collection. Oversees clinical trial sample testing activities and data capture to support CDx regulatory submission or associated drug ... Liaisons to ensure successful implementation of CDx and data collection Supports Regulatory affairs in providing content and providing review of documents… more
- Merck & Co. (North Wales, PA)
- …medicines that help people around the globe. We are currently recruiting for Associate Director , US MarketingThe role will oversee foundational strategy and ... drive and align on decisions, including field sales, marketing operations, Legal, Regulatory , Medical, etc.Our US marketing team has adopted an Agile operating model… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …review of Study Date Tabulation Model (SDTM) and analysis (including Analysis Data Model (ADaM)) datasets as well as TLFs generated by statistical vendor, ... effective vendor programming implementation, and expedite the preparation of regulatory submissions. Responsibilities include: make strategic programming decision and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to study team on all aspects of statistical activities; collaborates closely with data manager to ensure high quality data .Drug Development Strategy: Provides ... at each phase of the development are scientifically sound, can fulfill regulatory requirements and deliver the pre-specified product profile.CRO / Vendor Oversight:… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. JOB SUMMARYThe Senior Director , Head Medical affairs Quality Assurance in Global RD/PV QA is accountable ... QA RDPVQA, and oversees multiple levels of direct reports (Directors, Associate Directors, Managers, contractors as applicable) across the Global Quality teams… more
