- Merck & Co. (Rahway, NJ)
- …skills include but are not limited to: - Serve as a Combination Product Regulatory Lead and provide leadership within Regulatory and cross-functional teams ... injectables; pre-filled syringes and/or autoinjectors. -- The successful candidate will lead the development and the implementation of regulatory strategies… more
- Formation Bio (New York, NY)
- …and commercial-stage biologic products, ensuring alignment with company goals and global regulatory standards. Team Development Build and lead a high-performing ... biologics manufacturing processes, formulation development, analytical methods, and global regulatory requirements. Proven ability to lead cross-functional teams… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionAs the Product Security Lead Designer, you will play a pivotal role in shaping the security landscape of our organization. Your primary ... responsibilities will include:Designing Security Controls: Lead the design and implementation of innovative and robust security controls across various domains… more
- Merck & Co. (Rahway, NJ)
- …of patients; the welfare of animals; comply with applicable global regulatory requirements through sound processes and procedures, and to provide independent ... assurance that delivers high quality data and clinical supplies. - The Compliance and Quality...critical activities in the areas of compliance, quality systems, regulatory intelligence, and the Quality Management System (QMS). -… 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 ... offers an opportunity for the Pharmacometrics leader to drive pipeline impact and lead a talented group of pharmacometricians.This Senior Director is expected to be… more
- Merck & Co. (Rahway, NJ)
- …projects.- Prepare materials for program presentations for management review and regulatory submissions, ensuring clarity and thoroughness. Lead the ... Job DescriptionJob Description The Senior Scientist, Device Design Control Lead , is a crucial member of our team, responsible for spearheading design control efforts… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Executive Director (ED) is the Clinical Operations lead in a country/cluster and is responsible for execution of all Clinical Trials in scope for ... cluster representative for initiatives at all levels of the organization.Build and lead the team to effectively manage resources ensuring appropriately skilled and… more
- Merck & Co. (Rahway, NJ)
- …Biologics programs (approximately 10-15 programs), and leading multiple Director lead Development teams, overall approximately 40-50 scientists. Strategic partnering ... Analytical Research and Development, Biologics Process Research and Development, CMC and Regulatory in aspects of control strategy and filings, Quality and our… more
- Merck & Co. (Rahway, NJ)
- …development, tech transfer of clinical or/and commercial processes, and pertinent regulatory filings. The incumbent will be responsible for recruiting, appraising, ... scientific excellence and compliance with our company's procedures for recording time, data entry, and trainings. The successful candidate will serve as a sounding… more
- Merck & Co. (Rahway, NJ)
- …& Manufacturing, in a fast-paced, multidisciplinary environment- - Participate in or lead 1) development of robust and scalable purification processes for biologics ... in different stages of clinical development, 2) process characterization and regulatory filings for successful commercialization - Advance downstream processes by… more
- Merck & Co. (Rahway, NJ)
- …the Director of the Raw Materials and Medical Devices/Combination Products (MDCP) will lead a team of specialists and scientists in Rahway supporting raw material, ... a state of inspection readiness.- The Director should be well engaged with regulatory and industry trends and have thorough working knowledge of GMPs, ICH, and… more
- Merck & Co. (Rahway, NJ)
- …scientists with a focus on drug substance (API) analytical deliverables to drive lead -time reduction and efficiency gains in support of our company's World Class ... and validation protocols and reports, technical reports, experimental designs, regulatory submission documents, etc.Perform investigations with strong technical troubleshooting… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …around rare diseases and immune disorders. SummaryThe Regulated Implementation Services Lead plays a key role in overseeing the development, validation, ... electronic records, validation processes, and regulated applications meet strict regulatory requirements, industry best practices, and internal quality standards.… more
- Merck & Co. (Rahway, NJ)
- …Primary Responsibilities and Activities include but are not limited to : Lead an Integrated Cross-Functional Team in Delivery of Reliable and Compliant Supply: ... Changes, Technical Transfers, Equipment Maintenance, Reliability, and Lifecycle Management). Lead Periodic Business and Operations Review Meetings (with External… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …with lead CDx RA representative(s) and represent Global CDx Regulatory position and provide input and updates within internal cross-functional teams (eg, ... an assay into clinical testing (before testing) and once data is ready for CDx submission (after testing)Serve as...device company HA meetings as appropriateIn collaboration with therapeutic Regulatory leads and CDx lead develop key… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …global data management strategy across regions and across studies/programs. Lead DM resource model internalization for both strategy and implementation in terms ... data review and cleaning, database lock), to ensure data quality/integrity and regulatory complianceEnsures that Data Management Plans are consistent and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …from clinical trials or post-marketing for completeness, accuracy, expectedness and relatedness. Lead internal and external (especially regulatory , but also ... Disease/Specialty Medicine portfolio. SummaryThe Director, Clinical Safety, will be a product safety lead or part of a product safety team, and be responsible for… more
- Eisai, Inc (Nutley, NJ)
- …we want to hear from you. Director, HCP Marketing, Alzheimer's Disease will lead several core marketing, strategy, and lifecycle planning projects focused on the ... This role represents a key opportunity for a talented, passionate marketer to lead important and innovative commercial work streams for a highly visible AD brand.Job… more
- Eisai, Inc (Nutley, NJ)
- …scientific support for clinical development planning, study design/execution, and data monitoring to ensure successful implementation of high-quality clinical ... development programs. Lead and manage moderately complex clinical research areas and...and provide input into clinical issues, adverse events, laboratory data and patient inclusion/exclusion criteria.Adapt and present complex scientific… more
- Eisai, Inc (Nutley, NJ)
- …Clinical Development resides within the Oncology at Eisai. This Executive Director will lead franchise programs, and will be the clinical group leader for the ... opinion leaders, advisors as well as US and EU regulatory bodies in order to conduct Phase I, Phase...studies, and prepare related documentation for submissions.This position will lead a development team with approximately 2-3 MD's or… more
