- Merck & Co. (Rahway, NJ)
- …regulatory updates.Audit vendors/partners of SaMD/IVD/Companion DiagnosticsReports to - Director Regulatory Compliance, Device Quality and RegulatoryLocation ... position will be part of the Device Quality & Regulatory Team within Global Regulatory Affairs and Clinical Safety (GRACS). The primary responsibility for… more
- 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)
- …working with contract manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub team and ... applications/supplements & variations (eg, NDA, BLA, MAA). This position authors regulatory documents where necessary with supervision. This position conducts … more
- Merck & Co. (Rahway, NJ)
- …in West Point, PA / Rahway, NJ is seeking a curious and collaborative Associate Director to support our robust infectious disease and vaccines pipeline. - ... As an Associate Director , you will represent QP2 on...vendors and partners, creating an aligned, quantitative and model-informed regulatory framework to impact strategies and decisions of drug… more
- Eisai, Inc (Exton, PA)
- …Quality Control, Regulatory , and CMC Program Management departments.The Associate Director of Biologics Operations maintains knowledge of established ... your profile, we want to hear from you. The Associate Director of Biologics Operations Upstream and...for Biologics Pilot Plant campaigns. Support providing data for regulatory documents as required.7. Ensure adherence of operations to… more
- Merck & Co. (Rahway, NJ)
- …Pharmacology and Pharmacometrics - Immune/Oncology (QP2-IO) team in the role of Associate Director , Quantitative Systems Pharmacology (QSP) . QP2-IO team is ... of oncology drugs from post-PCC to registration. As a subject matter expert, the Associate Director within the QP2-IO Group will work closely with teams of… more
- Merck & Co. (Durham, NC)
- …Division is seeking a highly motivated individual for the role of Associate Director within the Vaccine Manufacturing Facility (VMF) Technology organization. ... The Technical Operations Associate Director will collaborate cross-functionally within the...SOPs, change requests, protocols, CAPAs, Quality Risk AssessmentsSupport of regulatory audits with coaching Subject Matter Experts (SMEs) and… 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …design pull you in? Are you ready to experiment with us? The Position The Associate Director of Nephrology Key Opinion Leader Marketing will be a pivotal driver ... with brand/therapy area vision and message. Relationships Reports to Senior Director of Cardio Renal Marketing Responsible for providing interface with key… more
- Genmab (NJ)
- …readiness, regulatory compliance, and successful data submissions.The Associate Director will lead cross-functional collaboration, provide oversight ... feel like a fit? Then we would love to have you join us!The RoleThe Associate Director , External Data Quality Management, is a strategic leadership role within… more
- Eisai, Inc (Nutley, NJ)
- …make a difference. If this is your profile, we want to hear from you. Associate Director , Medical Education - Oncology, is responsible for the strategic planning ... & ManagementEisai Salary Transparency Language:The base salary range for the Associate Director , Medical Education - Oncology is from :162,600-213,400Under… more
- Eisai, Inc (Nutley, NJ)
- …a difference. If this is your profile, we want to hear from you. The Associate Director (AD), Global Medical Affairs Training and Education is responsible for ... & International). Eisai Salary Transparency Language:The base salary range for the Associate Director , Global Medical Affairs Training and Education is from… 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …improving the lives of more patients than ever before. The Position The Associate Director , Rare Bleeding Health Care Professional Marketing Experience has ... Reports to the Rare Bleeding Disorders TA lead (A/B). Works closely with Associate Directors and Senior Brand Managers across the Rare Bleeding Disorders TA and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …strong collaborators, as we embark on shaping our future. The Position The Associate Director , Rare Bleeding Health Care Professional Marketing Experience has ... Reports to the Rare Bleeding Disorders TA lead (A/B). Works closely with Associate Directors and Sr Brand Managers across the Rare Bleeding Disorders TA and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …collaborators, as we embark on shaping our future. The Position The Associate Director , Strategic Collaboration role is responsible for fostering partnerships ... the rare disease landscape, including knowledge of key stakeholders, regulatory requirements, and emerging trends Exceptional negotiation, communication, and… more
- Legend Biotech USA, Inc. (Chicago, IL)
- …of multiple myeloma.Legend Biotech is seeking a Regional Key Customer Marketing (Central) Associate Director as part of the Commercial team based in (but ... are always within label, and consistent with commercial, compliance, legal and regulatory guidelines.The KCM will work closely, and within approved SOPs, with other… 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
- Merck & Co. (Upper Gwynedd, PA)
- …of cross functional teams compromised of Global Supply Chain, Global Regulatory Affairs, Labeling, Material Master Data, Finance, Quality, Transfer Team, Transfer ... processes, product physical & financial flows, and awareness of regulatory , quality, and technical processes/ requirements.Primary activities include, but are… 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 ... Optimization, Project Management, Project Portfolio Management (PPM), Publications Management, Regulatory Compliance, Risk Management, Sourcing and Procurement, Strategic Planning… more
