- 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
- 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. (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)
- …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. (Rahway, NJ)
- …process validation, second generation process development and authoring of regulatory submissions.-Under the general scientific and administrative direction of the ... this individual will support late stage and commercial large molecule biologics program activities. The individual will be responsible for leading a team to… 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
- Insmed Incorporated (San Diego, CA)
- …transfers and mentoring junior staff. Maintaining laboratory equipment, ensuring safety and regulatory compliance , and supporting audits are also part of the ... Unit (internal or external QC). May act as a program lead on a PDT as required by the...issues. Contributes to method qualification and validation according to regulatory guidelines such as ICH, FDA, and cGMP, evaluating… 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
- 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 healthcare provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… 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
- Merck & Co. (Boston, MA)
- …development (MIDD) to routinely enable efficient drug discovery/development and/or regulatory decisions. The Pharmacometrics group within QP2 brings an experienced ... the following responsibilities . Responsible for achieving results on major program deliverables by identifying, driving the development and implementation of one… more
- Merck & Co. (Rahway, NJ)
- …and transfer using immunoassay techniques.Extensive knowledge and experience with regulatory guidance and industrial standards of control strategy for residual ... transfer of assays. Plan assay optimization and documentation to meet program deadlines.Authoring and reviewing internal technical reports, sections of regulatory… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Public Policy, Regulatory , Legal, IT, Trade, Patient Safety and Compliance . External relationships include affordability program vendors. Essential Functions ... channels Manages and monitors ongoing affordability vendor training assignments for program compliance Physical Requirements 10-20% overnight travel required.… more
- Merck & Co. (Durham, NC)
- …when requested. This position will focus on maintaining the calibration program , including implementation of new instruments for calibration, investigation into ... sessions to support investigations and develop appropriate CAPAs which lead to program improvements.Review and approve out of tolerance (OOT) records and ensure… more
- Eisai, Inc (Nutley, NJ)
- …milestones across programs in compliance with Eisai's SOP's and regulatory guidelines.Direct program level oversight of Clinical development plans (CDP) ... opinion leaders, advisors as well as US and EU regulatory bodies in order to conduct Phase I, Phase...(or equivalent role) with Global Clinical Lead or Clinical Program Director accountability. Proven experience in running clinical studies… more
- Merck & Co. (Durham, NC)
- …leadership skills to empower teams, solve complex technical challenges, and ensure compliance with industry standards while making a tangible impact on our ... when requested. This position will focus on maintaining the calibration program , including implementation of new instruments for calibration, investigation into… 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 ... work collaboratively with other leaders in Clinical Development and Global Regulatory Affairs.--The AVP provides leadership and direction through senior-level and… more
- Aequor (Hicksville, OH)
- …etc.). Ensures all work is performed in a safe, effective manner, and in compliance with the appropriate industry and regulatory (FDA, DEA, OSHA) standards, and ... cleaning tasks on machine during or after machine operation. Maintains compliance with SOPs, good documentation practices (GDP), training requirements, Company and… more
