- Merck & Co. (Rahway, NJ)
- …device and combination products, guiding cross-functional teams to ensure regulatory compliance throughout development and commercialization. Mentor team ... Combinations CMC (Chemistry, Manufacturing & Controls), you will report to the Director of Device Regulatory Affairs for Autoinjector Development Programs. You… more
- Merck & Co. (Rahway, NJ)
- …degree with 12+ years of industry experience, including regulatory and/or compliance area and experience with process management in a regulated ... maintaining efficient, effective, and compliant business standards, process maps, and risk management for global processes across Global Regulatory Affairs and… more
- Daiichi Sankyo, Inc. (Bernards, 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...through all labeling discussions with the FDA/CHMP while ensuring management alignment. Strategizes and plans for FDA meetings as… more
- Merck & Co. (Rahway, NJ)
- …ethics-committees, and internal auditors in conjunction with CCQM, compliance , Regulatory ,-Pharmacovigilance (PV) and Medical Affairs.Responsible and ... Job DescriptionThe Clinical Research Director (CRD) is the Clinical Operations lead in a country/cluster and is responsible-for execution of all Clinical Trials in… more
- Merck & Co. (Rahway, NJ)
- …cross-functional development teams to enable pipeline decisions. -The Executive Director , Biologics Analytical Research and Development (B-AR&D) is responsible for ... of Biologics programs (approximately 10-15 programs), and leading multiple Director lead Development teams, overall approximately 40-50 scientists. Strategic… more
- Merck & Co. (Rahway, NJ)
- …Capital Process having participated on a large capital project teamExperience in regulatory compliance expectations across all phases of product development to ... portfolio. Within Biologics and Biopharmaceutics, the large molecule product development Director will influence the strategy, lead activities, and develop a team… more
- Merck & Co. (Rahway, NJ)
- …products and processes are developed in accordance with applicable regulatory , quality, company, and customer requirements.-This position will lead cross-functional ... process development, qualification, and validation; and design control and risk management techniques to positively support and influence clinical and commercial… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …in associated contractual templates. Ensures Good Pharmacovigilance Practice and regulatory compliance in such arrangements. Oversees Local/Global ... and proactively drive operational excellence and continuous improvement. Oversees the management of Global PV Regulatory Intelligence (PVRI) and dissemination… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionJob Description Director -QP2-IO We are seeking an experienced talented scientist to join the - Quantitative Pharmacology and Pharmacometrics - - ... Immune/Oncology - (QP2-IO) - team in the role of Director . QP2-IO team is part of the Global Clinical...and survival. A Maintaining a comprehensive understanding of global regulatory expectations for small molecules and biologics in Oncology,… more
- Merck & Co. (Rahway, NJ)
- …development (MIDD) to routinely enable efficient drug discovery/development and/or regulatory decisions. The Pharmacometrics group within QP2 brings an experienced ... therapeutic areas and modalities to drive portfolio impact from discovery through life-cycle management . The team is externally visible and continues to be at the… more
- Merck & Co. (Rahway, NJ)
- …and Pharmacometrics - Immune/Oncology (QP2-IO) team in the role of Associate Director QP2-IO team is part of the Global Clinical Development organization and ... development and effective communication skills. As a subject matter expert, the Associate Director within the QP2-IO Group will work closely with teams of highly… more
- Merck & Co. (Rahway, NJ)
- …site, region, and global business partners to drive prioritization of regulatory compliance , continuous performance improvement, and integration of EHS ... applying regulatory frameworks and keeping abreast of the changing regulatory landscape.Strong leadership, change execution, and financial management skills… more
- Merck & Co. (Rahway, NJ)
- …company's tax planning efforts, responsible for guiding our strategic vision, ensuring compliance with regulatory developments, and positioning the company for ... Job DescriptionJoin us as an Executive Director of Tax Planning to lead our tax...positioning the company advantageously in the US and OECD regulatory landscapes.Cross-Functional Collaboration: Partner with leaders across finance, treasury,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …planning, coordination, and implementation of Development SOP activities to ensure regulatory compliance and cross functional cohesiveness across SOPs and ... Director , Development SOP Management Join a...of view and provide guidance to authors to ensure regulatory compliance , consistency and connectiveness across SOPs.… more
- Merck & Co. (Rahway, NJ)
- …pharmacokinetics modeling software (eg, Simcyp, GastroPlus) is highly desired.Experience in regulatory compliance expectations across all phases of product ... compliance mindset.Essential Knowledge, Duties & Responsibilities for the Director Include:Biopharmaceutics expertise supporting delivery of small molecule, peptides… more
- Merck & Co. (Rahway, NJ)
- …development (MIDD) to routinely enable efficient drug discovery/development and/or regulatory decisions. The Pharmacometrics group within QP2 brings an experienced ... therapeutic areas and modalities to drive portfolio impact from discovery through life-cycle management . The team is externally visible and continues to be at the… more
- Merck & Co. (Rahway, NJ)
- …the Research & Development pipeline and realize its full potential. The Associate Director is expected to provide project management leadership and drive ... Project Manager is part of Global Project and Alliance Management (GPAM) which sits in the Research & Division...our company. - Position Description/Summary: - The GPAM Associate Director , Project Manager, is a core member of Early… 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 ... incumbent will play a pivotal role in meeting cross-divisional and regulatory requirements by their strong scientific background, excellent communications skills,… more
- Merck & Co. (Rahway, NJ)
- …transformation that reflects the evolving demands of our business. Risk Management :-Proactively identify potential technical, operational, and regulatory ... Job DescriptionWe are seeking a visionary Executive Director to lead our End-to-End Technical Leader organization...the lifecycle of product franchises, (2) project and portfolio management support across pipeline and supply, and (3) the… more
- Merck & Co. (Rahway, NJ)
- …other R&D departments that have logistics support needs and/or Trade compliance consultation or operations support needsEnsure an exquisite partnership with Global ... Clinical Trial Operations, Regulatory and other Development Sciences and Clinical Supply (DSCS)...with external partners like freight forwarders, couriers and brokers.Ensure compliance with all applicable regulations impacting clinical trials and… more
