- Merck & Co. (Rahway, NJ)
- …Medical Devices, Mentoring Staff, Ophthalmology, Pathophysiology, People Leadership, Physiology, Program Management, Regulatory Affairs Compliance {+ ... and effective implementation and oversight model to maintain best in industry regulatory compliance .The Vice President Regulatory Affairs, General Medicine… more
- Merck & Co. (Rahway, NJ)
- …Regulations, Management Process, Pharmacovigilance, Policy Implementation, Regulatory Affairs Compliance , Regulatory Compliance , Regulatory Labeling, ... experience and skills: Min. 5-10 years of experience with Pharmaceutical Regulatory Affairs Operations with Labeling Process and/or Digital Enablement experience… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Are you ready? The Position Responsible for leading process, reporting and compliance related activities for US Talent Acquisition. Responsible for oversight of ... related to US Talent Acquisition. Ensures utilized solutions are compliant with regulatory requirement and advises on the same. Ensures Talent Acquisition functions… more
- Merck & Co. (Rahway, NJ)
- …Optimization, Project Management, Project Portfolio Management (PPM), Publications Management, Regulatory Compliance , Risk Management, Sourcing and Procurement, ... key partner organizations ( as a lead GCS Planning program representative ) such as clinical development, regulatory...applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los… more
- Merck & Co. (Rahway, NJ)
- …Capital Process having participated on a large capital project teamExperience in regulatory compliance expectations across all phases of product development to ... formulation, manufacturing process, and primary packaging to enable phase appropriate regulatory filings for large molecule sterile products. -These sterile products… more
- Merck & Co. (South San Francisco, CA)
- …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
- Merck & Co. (Durham, NC)
- …Multi-Management, People Leadership, Physical Sciences, Production Management, Project Management, Regulatory Compliance {+ 2 more}-Preferred Skills:Job Posting ... role in our EHS organization available which is accountable for all EHS program execution and compliance at our Manufacturing Division's vaccine manufacturing… more
- Merck & Co. (Millsboro, DE)
- …Packaging Operations, People Leadership, Process Engineering, Process Improvements, Production Scheduling, Regulatory Compliance , Regulatory Policies {+ 5 ... other departmentsReview and revise processes and procedures against corporate and regulatory policies.Review production records for completeness and compliance … more
- Merck & Co. (North Wales, PA)
- …Trials Analysis, Data Analysis, Data Management, Data Science, Numerical Analysis, Physiology, Regulatory Compliance , Regulatory Requirements, Regulatory ... (LDP) to ensure that study designs are consistent with program objectives and meet worldwide regulatory and...applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los… more
- Merck & Co. (Rahway, NJ)
- …and inhaled dosage forms.Provide active strategic and technical leadership on program development teams, interfacing with key stakeholders, and collaborating across ... packaging, compatibility characterization for processing and administration, and supporting regulatory filings.Collaborate with key stakeholders across the organizations (Research… more
- Merck & Co. (Rahway, NJ)
- …controls approach within Device Development and with external suppliers.Understand and apply regulatory / compliance requirements relative to design controls and ... risk management activities.Lead the preparation of materials for program presentations for management review and regulatory submission.Contribute to the… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Partner where requested by management Develops comprehensive, relevant resources (eg training program , FAQs) to enable compliance with QMS process requirements ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...COE Develops and executes regular surveillance, follow-up, and reporting program to ensure process compliance within the… more
- Merck & Co. (Rahway, NJ)
- …in the design, manufacturing, verification, validation and associated quality and regulatory aspects of combination products.The incumbent must be able to lead ... full integration of the device development activities with the clinical, regulatory , formulation, commercial and other key company functions.Lead the Device… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …standards and processes as applicable Develops comprehensive, relevant resources (eg training program , FAQs) to enable compliance with quality control process ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...provides input to support regular surveillance, follow-up, and reporting program to ensure process compliance within the… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …external health authority regulations Develops comprehensive, relevant resources (eg training program , FAQs) to enable compliance with Deviation process ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...applicable Develops and executes regular surveillance, follow-up, and reporting program to ensure process compliance within the… more
- Merck & Co. (Rahway, NJ)
- …art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for ... under supervision in Late Development Statistics. --Interacts with Clinical, Regulatory , Statistical Programming, Data Management and other company Research… more
- Merck & Co. (San Francisco, CA)
- …development (MIDD) to routinely enable efficient drug discovery/development and/or regulatory decisions. The Pharmacometrics group within QP2 brings an experienced ... in several areas, including: - Responsible for achieving results on major program drivers by implementation of one or more novel quantitative approaches that… more
- Merck & Co. (North Wales, PA)
- …art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for ... the span of which range from individual clinical trials to world-wide regulatory application submissions and post marketing support.The incumbent is responsible for… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …around rare diseases and immune disorders. SummaryThe Manager Audits & Compliance , GCP/Document Audits supports end-to-end audit activities per audit program ... its partners as applicable ensuring the execution of a risk-based audit program and effective CAPA management resulting from audits, health authority inspections… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …and manage relationships with contractors to ensure quality of work and compliance with all company policies and regulatory guidelinesHelps improve metric ... PLCs, VFDs and electrical practices generally attained through hands-on experience, cGMP compliance , EHS and regulatory standards (eg EPA, OSHA and… more
