- 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …legal regulatory or compliance experience is required Technology and data analytics experience in a pharmaceutical or medical device compliance function is ... the Ethics & Compliance (E&C) Monitoring & Auditing function, prioritizing data analytics, trends, and insights in alignment with evolving government expectations,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …of the Novo Nordisk US Operations (USO) AI Center of Excellence. The individual will lead and manage a team of data scientists, including AI/ML experts and ... evolve the Data Science team to meet internal and market needs. Lead a high-performing, collaborative team environment.Core member of the AI Center of Excellence,… 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
- Tris Pharma (Monmouth Junction, NJ)
- …(OOS/OOT/Lab Event) and manufacturing investigations and CAPAs/CPIs Performs in-depth data analysis to identify compliance concerns, root causes and recommend/ ... not limited to: investigative processes, CAPAs and CPIs, etc.Participates in regulatory agency inspections and customer audits, as needed; Performs and/or… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Pharmacovigilance, handling and processing of raw data and external data , CDASH/SDTM, industry best practices, and relevant regulatory requirements is ... ensure compliance with the programming standards and practices, SOPs, external/internal data standards, Good Clinical Practices (GCPs), applicable regulatory … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …responsible for operational and technical oversight of QA across GxP (GCP/GVL/GCLP/GLP) systems. Lead the development of the global Data Integrity strategy and ... quality and integrity initiatives.Develop and implement proactive strategies to address data integrity issues identified during regulatory inspections, such as… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …technology, and standards. This position ensures quality delivery of laboratory data for clinical trials, clinical development, and regulatory submissions. ... advanced knowledge of medical terminology capture and reporting of safety data , pharmacovigilance, industry best practices, and relevant regulatory requirements.… 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)
- …and associated data collection. Oversees clinical trial sample testing activities and data capture to support CDx regulatory submission or associated drug ... Liaisons to ensure successful implementation of CDx and data collection Supports Regulatory affairs in providing content and providing review of documents… 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …strategy, focusing on every touchpoint that impacts our customers. We leverage data and insights to inform our decision-making processes, ensuring that our ... functional teams in NNI (including MAPA), including marketing, medical, R&D, regulatory affairs, finance, NNGlobal, and other relevant entities to develop brand… 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …safety, managing our supply chain and sampling, supporting technological and data innovation, maintaining our facilities and assuring the integrity and completeness ... process for Novo Nordisk's top PBM/payer accounts. Acts as PCOR Account Lead responsible for leading company response from Deal to Contract (includes pre-deal… 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
- 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
