- Merck & Co. (San Diego, CA)
- …approval for IND/CSA submissions to enable clinical trial initiation.Participate in regulatory due diligence activities for in- licensing opportunities. Education ... Job DescriptionThe Global Regulatory Liaison is responsible for developing and implementing worldwide regulatory strategies for assigned projects within the… more
- Merck & Co. (Rahway, NJ)
- …as well as preparing for, management and follow up of regulatory inspections.Operational Quality Management:The Clinical Quality Operations Manager is accountable ... Preparation and Management:The CQOM is responsible for maintaining current regulatory inspection knowledge as it relates to Good Clinical Practice… more
- Merck & Co. (Rahway, NJ)
- …and supply.A key workstream within this initiative is the auto-generation of regulatory filing sections, enabled by a dedicated application designed to create a ... frictionless flow of data from source systems to regulatory documentation.- Under the guidance of dCMC Leadership, the Senior Specialist, Digital CMC Data Analyst,… more
- Merck & Co. (Rahway, NJ)
- …device engineering, particularly in the design, manufacturing, and regulatory aspects of Autoinjectors and combination products.Primary Responsibilities:Technical ... and manufacturing of Autoinjectors, ensuring compliance with industry standards and regulatory requirements (eg, ISO 13485, FDA regulations). Actively seek out,… more
- Merck & Co. (Rahway, NJ)
- …compatibility characterization for processing and administration, and supporting regulatory filings. Collaborate with key stakeholders across the organizations ... Maintain a strong network internally and across the external academic and regulatory community and build collaborations across internal company departments and key… more
- Merck & Co. (Rahway, NJ)
- …alignment with the company's business goals, and quality and regulatory compliance.-Essential Duties and Responsibilities:Utilize extensive experience in design ... both development and lifecycle management, ensuring compliance with relevant regulatory standards.Ensure robust technical plans, risk communication, drive technical… more
- Merck & Co. (Rahway, NJ)
- …alignment with the company's business goals, and quality and regulatory compliance.-Essential Duties and Responsibilities: Strategic Leadership and Project ... with receiving sites, drug product partners, and Technical Product Leaders, regulatory and quality.Provide Voice of Manufacturing input to early development teams… more
- Merck & Co. (Rahway, NJ)
- …efficient management of data across the organization, including compliance with regulatory standards, and the optimization of laboratory operations and workflows via ... emerging technologies to recommend innovative solutions in compliance and regulatory ISO-13485 standards.Stakeholder EngagementCommunicate effectively with stakeholders at all… more
- Merck & Co. (Durham, NC)
- …management, risk mitigation, deviation management, technical protocols/reports, and BLA/MAA regulatory license documents.-Strong ability to collaborate and ... strong and trusting relationships with site technical operations, quality, regulatory , stability, and other stakeholders to ensure effective communication of… more
- Merck & Co. (Durham, NC)
- …management, risk mitigation, deviation management, technical protocols/reports, and BLA/MAA regulatory license documents.-Proven ability to collaborate and lead ... strong and trusting relationships with site technical operations, quality, regulatory , stability, and other stakeholders to ensure effective communication of… more
- Merck & Co. (Durham, NC)
- …systems regarding functionally of equipment and relied on as SME during regulatory discussions for Electrical and Automation and the commissioning of that equipment. ... and predictive maintenance programs to assure compliance with quality, regulatory , and reliability requirements and goals.Track maintenance and reliability metrics… more
- Merck & Co. (Rahway, NJ)
- …process validation, second generation process development and authoring of regulatory submissions.-Under the general scientific and administrative direction of the ... next generation process development and characterization, process validation, and regulatory submission authoringIn this role, the successful candidate will be… more
- Merck & Co. (Rahway, NJ)
- …risks across all factors that may impact technical, operational & regulatory success or timelines. -Analyzes and develops innovative solutions to unforeseen ... challenges, proactively prioritizing, interrogating and mitigating risks across technical, regulatory and operational factors.- Conducts options analysis and provides… more
- Merck & Co. (Rahway, NJ)
- …teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new drugs, vaccines and new indications for existing ... of clinical development, including study design, initiation, execution,-monitoring, analysis, regulatory reporting, publication, and presentation at national and international… more
- Merck & Co. (Boston, MA)
- …stakeholders to ensure alignment with clinical development timelines and regulatory requirements. Most importantly, the role requires overseeing CDx development, ... stay up to date regarding industry trends and diagnostic regulatory requirements. Essential Job Requirements:Develop end-to-end diagnostic strategy in collaboration… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …CSPV and external functions including Clinical Development, Research Development, Regulatory Affairs.Facilitate operational meetings with CROs, License Partners, ... language in associated contractual templates. Ensures Good Pharmacovigilance Practice and regulatory compliance in such arrangements. Contribute to the management of… 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 ... cycle time, cost/size and number of trials, implementation of tools and regulatory framework for rapid approvals and driving Go/No Go decisions on programsFoster… more
- Merck & Co. (Rahway, NJ)
- …patient care advances. The GDMA coordinates medical affairs activities to resolve regulatory , reputational, ethical, and other asset management issues and is part of ... in and contribute significantly to professional organizations, academic or regulatory working teams Asset Regulatory Management Successfully collaborate… more
- Rocket Lab Corporation (Long Beach, CA)
- …data, and issued licenses. Keep the Rocket Lab internal wiki updated with license application summaries and status. Licensing Strategy Development Stay informed ... about existing and emerging radio communications systems and missions. Develop licensing strategies aligned with mission requirements and regulatory frameworks.… more
- Merck & Co. (South San Francisco, CA)
- …external vendors and partners, creating an aligned, quantitative and model-informed regulatory framework to impact strategies and decisions of drug discovery and ... reporting and interpretation of data. Maintain a comprehensive understanding of global regulatory expectations and shape, present and defend regulatory documents… more
