- Merck & Co. (Rahway, NJ)
- …Experience and Skills - Experience implementing or supporting automated regulatory authoring (structured content, template-driven generation, or document ... supply. - A key workstream within this initiative is the auto-generation of regulatory filing sections, enabled by a dedicated application designed to create a… more
- Aequor (Thousand Oaks, CA)
- …degree and a minimum of 2 years of hands-on experience in document management, including workflow coordination and system administration. Proficiency with Viva or ... comparable document management platforms is required. Strong background in project...management of R&D controlled documents to ensure compliance with regulatory standards and internal quality procedures. This role emphasizes… 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. (Lower Gwynedd, PA)
- …utilized to generate pivotal safety and efficacy clinical patient data required for regulatory filings. -As the AdVAnce facility will not be fully constructed and ... computer sciences, medical technology, business management, etc.-Responsibilities-Strong knowledge of document or training management systems. May also be involved… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …processes across the global safety organization. The incumbent will ensure regulatory compliance, promote best practices, foster a culture of continuous improvement ... and fosters a culture that seeks to constantly enhance global regulatory compliance to meet signal evaluation timelines.Develop quality systems and procedures… more
- Genmab (NJ)
- …a fit? Then we would love to have you join us!The Global Regulatory Labeling, Policy and Intelligence Associate Director will primarily be responsible for leading ... portfolio of products. The lead may also be responsible for supporting various regulatory policy and/or intelligence deliverables. This role will be within Global … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …language in associated contractual templates. Ensures Good Pharmacovigilance Practice and regulatory compliance in such arrangements. Contribute to the management of ... PV Regulatory Intelligence (PVRI) and dissemination across CSPV stakeholders for impact assessment. Participates in the review and management of monthly, quarterly,… more
- Repligen (Waltham, MA)
- …supporting root cause investigations, and ensuring Repligen's supplier network meets regulatory and quality standards. This role is based in Waltham, MA, ... Supplier Change Notifications to ensure compliance with internal and regulatory quality standards.Coordinate cross-functional teams to assess and mitigate risks… more
- Merck & Co. (North Wales, PA)
- …effectiveness to the business and communicate suggestions for improvement Document needs for customization or localization of learning programsReview ... in medical/legal/ compliance (CRT) reviews-Understanding of the US and Global regulatory stages and requirements-Job Owner - Fully responsible for asset management… more
- Merck & Co. (Rahway, NJ)
- …and 3rd party logistics sites, supply chain and technology teams, and regulatory and project leaders. The successful candidate will demonstrate ownership and make ... strong relationships with internal stakeholders, including commercialization, quality, analytical, regulatory , manufacturing, and Supply Chain to facilitate effective technical… more
- Aequor (Irvine, CA)
- …and clinical customer complaints. Perform hands-on technical investigations and document results per established procedures and timelines. Performs hands-on ... requirements and standards, including FDA, ISO 13485, and other worldwide regulatory agencies pertaining to medical devices Minimum Requirements: Bachelor's Degree -… more
- Repligen (Clifton Park, NY)
- …ensure a motivated and effective team environment Provide training in document -controlled manufacturing techniques. Approve shift schedules and vacation requests to ... production leads as required. Ensure compliance with GMPs, SOPs, and all regulatory standards that are carried out in accordance with Repligen's Quality Management… more
- Merck & Co. (North Wales, PA)
- …coaching on Company processes relating to CMC development team management, strategic document preparation, PM skills, and Team Management. -Work to ensure that PM ... Budgeting, Project Management, Project Planning, Project Scheduling, Project Strategy, Regulatory Compliance, Results-Oriented, Risk Management, Software Project Management {+… more
- Merck & Co. (Durham, NC)
- …maintain own training status and ability to train others. Participate in document design activities working alongside operations team members to develop reliable, ... hands-on training Experience with on-the-floor cGMP manufacturing and familiarity with regulatory requirements Demonstrated ability to work both independently and as… more
- Formation Bio (New York, NY)
- …to align semantic models with real-world use cases. Enablement & Documentation: Document data standards and reusable modeling patterns to empower downstream teams ... workflows (NLP, embeddings, semantic search, knowledge graphs). Understanding of regulatory and compliance considerations in healthcare, pharma, or finance.… more
- Aequor (Thousand Oaks, CA)
- …across functions, troubleshoot distribution issues, and ensure compliance with regulatory and quality standards. Key Responsibilities and Activities General: - ... Providers - Partner with clinical site staff and Quality to document , investigate, and communicate decisions concerning distribution complaints. Sales Order… more
- Monster (Newark, DE)
- …with the CEO to take, transcribe, and distribute minutes, ensuring timely regulatory uploads and document retention. Coordinates domestic and international ... travel for the CEO, working with internal and external stakeholders including investors, regulators, and consultants. Submits expense reports, processes contracts and corporate documents, and supports legal and administrative tasks tied to committee and… more
- Aequor (East Syracuse, NY)
- …and stability samples in compliance with methods, procedures, protocols and regulatory requirements. The QC Microbiology Laboratory technician performs lab analysis ... to scientific protocols. Maintain accurate records of work performed and document results, according to good documentation practices and established procedures, as… more
- Eisai, Inc (Exton, PA)
- …and deliverables (drawings, specification, etc.) Lead team review of designs and document decisions. Responsible for the design of new applications. Prepare small to ... with site technical and operations personal to ensure that business needs and regulatory requirements are met by the control systems. Ensure adherence of operations… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …gets to work on this. You have strong knowledge of cGMP requirements. You document proposals to reach a solution with relevant stakeholders (eg QA, C&Q, Operations, ... in a fast paced and dynamic, growing environment.Strong understanding of regulatory and compliance requirementsExcellent oral and written communication skills Highly… more
