- Twist BioScience (South San Francisco, CA)
- …labeling, and SOP's. This role is crucial in supporting global product compliance , ensuring that all documentation accurately reflects regulatory requirements ... The Regulatory Operations Specialist is responsible for ensuring the...Safety Data Sheets (SDS) for all Twist products, ensuring compliance with global regulations. Collaborate with cross-functional teams to… more
- Merck & Co. (Rahway, NJ)
- …scalable process, primary packaging, compatibility characterization for processing and administration , and supporting regulatory filings.Collaborate with key ... a strong network internally and across the external academic and regulatory community and build collaborations across internal company departments and key… 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
- Tris Pharma (Monmouth Junction, NJ)
- …liaison with Product Development (PD)/Quality Assurance (QA)/Quality Control (QC)/ Regulatory Affairs, including reviews/approvals of Change Control Reports (CCRs), ... required documentations and change control activities, in liaison with PD/QA/QC/ Regulatory AffairsDesigns experimental plans; Critically analyzes data and information… 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 ... products across a variety of therapy areas and routes of administration including inhalation, implantation, and injection.-- Job descriptionThis position will be… more
- Merck & Co. (Rahway, NJ)
- …products across a variety of therapy areas and routes of administration including inhalation, implantation, and injection.--This position serves as a senior ... in the design, manufacturing, verification, validation and associated quality and regulatory aspects of combination products.The incumbent must be able to lead… more
- Tris Pharma (Monmouth Junction, NJ)
- …negotiations, supplier relationship management, procurement systems functionality/workflows and assurance of compliance with GxP and other company and regulatory ... Ensures compliance with all current GxPs, Food and Drug Administration (FDA), Drug Enforcement Administration (DEA), and Occupational Health and… more
- Eisai, Inc (Raleigh, NC)
- …The QA Specialist plays a critical role in ensuring the quality and compliance of commercial and clinical products manufactured at the Eisai Raleigh facility. This ... is responsible for executing core quality assurance functions, supporting regulatory inspections, and collaborating with internal and external stakeholders to… more
- AUROBINDO (Durham, NC)
- …with expertise in manufacturing, R&D, Quality Assurance and Quality control and regulatory affairs. In addition to several formulations under manufacture, we have a ... following functional areas (but not limited to): recruitment, benefits administration , employee relations, leaves of absence, training, on-boarding, orientation,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …systemsPerform on-site equipment maintenance and critical utilities maintenance operations, and compliance . This includes but is not limited to: support to ... business operations.Support facility project initiatives as neededMaintain knowledge of and compliance to all applicable codes and regulations as required. Obtains… more
- Eisai, Inc (Nutley, NJ)
- …price reporting, patient support, as well as other pharmaceutical regulatory counseling. Essential Functions: Provides proactive and day-to-day legal support, ... support, patient assistance programs, adherence support).Works to ensure Eisai's compliance with pharmaceutical laws and industry guidelines including the… more
- Eisai, Inc (Nutley, NJ)
- …sales/business analytics) preferred.Experience working with pharmaceutical manufacturer compliance & regulatory requirements preferred.Experience navigating ... work cross-functionally while adhering to all of Eisai's ethics and compliance standards. Responsibilities: Responsible for sales and demand generation within… 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
- Eisai, Inc (Nutley, NJ)
- …research strategy across teams, to accomplish critical milestones across programs in compliance with Eisai's SOP's and regulatory guidelines.Direct program level ... opinion leaders, advisors as well as US and EU regulatory bodies in order to conduct Phase I, Phase...of Homeland Security in partnership with the Social Security Administration that allows participating employers to electronically verify the… more
- Merck & Co. (Rahway, NJ)
- …reimbursement and market access, and provide input into clinical, regulatory , payer/access, marketing and evidence generation strategy and programsIn collaboration ... outcomes research, epidemiology, public health, health economics, pharmacoeconomics, pharmacy administration )1-3 years post degreePreferredDoctoral degree (PhD, DrPH, ScD, PharmD)… more
- Merck & Co. (North Wales, PA)
- …reimbursement and market access, and provides input into clinical, regulatory , payer/access, marketing and evidence generation strategies and programs.In ... outcomes research, epidemiology, public health, health economics, pharmacoeconomics, pharmacy administration ).-Four or more years of experience post degree.PreferredDoctoral degree… more
- City of Spring Hill Kansas (Spring Hill, KS)
- …degree or professional certification in urban planning, public administration , engineering, architecture, landscape architecture, geography, or related field ... and experience may be considered. Master's degree in planning, public administration or business preferred. Eight years of progressively responsible and related… more
- Eisai, Inc (Nutley, NJ)
- …company. This role ensures studies are conducted efficiently, within budget, and in compliance with regulatory standards. The Head of Clinical Operations leads ... components. Key Responsibilities:Manage and oversee the clinical operations function, ensuring compliance with GCP and regulatory standards.Develop and implement… more
- Eisai, Inc (Phoenix, AZ)
- …approved promotional clinical trials, patient access to medication, and regulatory / compliance guidelines preferred.Experience with account planning and ... and safety messaging and information about product access / safe administration to relevant customer stakeholders in a compliant way.Monitor operating costs… more
- Repligen (Waltham, MA)
- …reporting (ICFR) in compliance with Sarbanes-Oxley (SOX) requirements.Ensure compliance with accounting standards and regulatory requirements, including SEC ... analytical approach with teams across the organization. Internal Controls & Compliance :Design, implement, and maintain effective internal controls over financial… more
