- Eisai, Inc (Nutley, NJ)
- …that he/she will be responsible for designing clinical trial, performing data analysis, supporting regulatory interactions, overseeing CRO activities, validating ... he/she will be responsible for designing clinical trial, performing data analysis, supporting regulatory interactions, overseeing CRO...the quality of CRO deliverables and on QA of data outputs. 10%5. Functions as lead statistician… more
- Eisai, Inc (Nutley, NJ)
- …ensures studies are conducted efficiently, within budget, and in compliance with regulatory standards. The Head of Clinical Operations leads teams of study managers ... the clinical operations function, ensuring compliance with GCP and regulatory standards.Develop and implement strategic vision and hands-on operational management… 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
- Formation Bio (New York, NY)
- …shelf-life memos, standard operating procedures and other technical documents following regulatory requirements. Experience in reviewing release data packages. ... of pre-clinical and clinical-stage large molecule asset acquisitions and lead analytical activities at contract development and manufacturing organizations (CDMOs)… more
- Merck & Co. (Rahway, NJ)
- …and technical leader with expertise in cell culture development & commercialization to lead a team of approximately 3-5 scientists, who lead multidisciplinary ... process validation, second generation process development and authoring of regulatory submissions.-Under the general scientific and administrative direction of the… more
- Merck & Co. (Rahway, NJ)
- …Chemical, Automation, Safety, Technical Services, Process Development, Analytical, Regulatory , and Quality.As part of Our Company's Manufacturing Division, ... manufacturing sites, manufacturing investigations, process validation, and authoring of regulatory submissions. -Under the general scientific and administrative direction… more
- Merck & Co. (Rahway, NJ)
- …in DS manufacturing operations (cell culture and purification) Strong understanding of regulatory requirements and inspection readiness Ability to lead without ... Job Description Lead the Future of Biologics Drug Substance Commercialization!...Provide technical oversight for DS process development, characterization, and regulatory filings Ensure smooth execution of PPQs and BLAs… more
- Merck & Co. (Rahway, NJ)
- …cell bank and working cell bank) manufacturing operationsStrong understanding of regulatory requirementsAbility to lead without authority, build trust, and ... Reporting directly to the Biologics Drug Substance Commercialization Leader, you will lead the Cell Banking working groups and drive innovation in biologics DS… more
- Merck & Co. (Rahway, NJ)
- …sites, manufacturing investigations, process validation, and authoring of regulatory submissions. -Under the general scientific and administrative direction ... and trend evaluations, process characterization, new WCB qualification, and regulatory submission authoring, with a focus on standardization across programs.In… more
- Merck & Co. (Rahway, NJ)
- …- Basic Functions & Responsibility As a member of the Device Quality & Regulatory QMS group, the Associate Director will participate in and/or lead various ... capabilities that touch every aspect of our business processes, systems, and data .The Associate Director will collaborate and interact with cross-function teams to… more
- Merck & Co. (Rahway, NJ)
- …leading squads and maintaining product lifecycle Manage scientific applications and lead squads to build user-friendly scientific data and technology ... in R&D IT brings together product management, engineering, and data science expertise. We enable data , technology...the RaDS Product organization. The position will report to the- Lead of the Disease Biology and PharmTox Product Line.… 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)
- …to customers both internal and external to GCS and serves as the lead GCS spokesperson at clinical and development related meetings.- Working independently, the ... are not limited to:--Interacts closely with key partner organizations (as a lead GCS Planning program representative) such as clinical development, regulatory ,… more
- Merck & Co. (Rahway, NJ)
- …data entry, data review/approval, and author analytical reports or data summaries.Troubleshoot and lead any investigations associated with GMP testing ... Job DescriptionContainer Closure Integrity Testing Lead , Associate Principal Scientist, Analytical Research & Development The Analytical Research and Development… more
- Merck & Co. (Rahway, NJ)
- …to ensure compliance and reduction in workplace Industrial Hygiene risks. Lead global continuous improvement initiatives to improve global Industrial Hygiene ... and consensus standardsAudit Industrial Hygiene records and prepare supporting data for required government, industry and management reports.Evaluate IH trends… 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 ... Director will perform job duties independently with minimal supervision and/or lead QP2 efforts on drug/vaccine development programs, and author or co-author… more
- Lundbeck (Bronx, NY)
- …in the primary care and neurology settings. As an Account Manager, you lead the promotion of our psychiatry portfolio, executing sales and marketing strategies with ... Planning & Account Leadership - Ability to use digital tools and apply data -based insights to create opportunities, develop strategy & tactics, allocate resources to… more
- Merck & Co. (Rahway, NJ)
- …Research & Manufacturing, in a fast-paced, multidisciplinary environmentParticipate in or lead 1) development of robust and scalable upstream processes for biologics ... different stages of clinical development, 2) process characterization and regulatory filings for successful commercializationAdvance upstream processes by improving… more
- Merck & Co. (Rahway, NJ)
- …and Diagnostics, in this role, you will serve as the translational lead on late-stage immunology programs, driving the Precision Medicine objectives in alignment ... be the authority in defining and interpreting the translational experiments and data generated respectively from our clinical trials, and understanding the potential… 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 ... aspects and interdependencies across DS, DP, Device, Packaging, and Analytical, Regulatory , Quality, and Supply Chain from early development through to commercial… more
