- Merck & Co. (Rahway, NJ)
- …8 years in the pharmaceutical industry with at least 5 years in Regulatory /Pharmacovigilance Function or Alliance Management .Understanding of regulatory and ... knowledge of Diversity and Inclusion principles.Desired Experience: Experience with Alliance Management and/or Regulatory strategy and process for partnerships… more
- Eisai, Inc (Nutley, NJ)
- …stakeholders from EIT and leaders across regions in Compliance, Ethics, Risk Management , Legal, Data Privacy, and Information Protection.Security ... compliance requirements across relevant jurisdictions.Update IT compliance policies based on regulatory changes.Establish a regulatory change management … more
- Merck & Co. (North Wales, PA)
- …constituent of a combination product.Review and approve Design Control and Device Risk Management documentation for regulatory filings, clinical supply, ... Design Controls / CAPA / Purchasing Controls as it related to 21CFR820. Risk Management experience (ISO 1497124971, ICH Q9).Effective communication skills and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …for overall product safety strategy or specific areas of safety surveillance and risk management , and provide safety leadership including but not limited to ... regulatory submissions. This individual will ensure proactive safety monitoring and risk management through the Safety Management Team framework. This… more
- Merck & Co. (Rahway, NJ)
- …across both diagnostics and pharma? Then you could be our new Global Marketing Director of Digital Diagnostics! - The Position: We are currently recruiting for a ... Marketing Director , Digital Pathology within our Precision Medicine, Global Oncology...across HH, our Research & Development Division, Medical Affairs, Regulatory , Legal etc. as well as external partners (diagnostic… more
- Merck & Co. (Rahway, NJ)
- … Regulatory Health Authority requirements.Experience with delivering effective CAPA management solutions.Experience with risk management tools and ... strategy for maintaining ongoing inspection readiness as well as preparing for, management and follow up of regulatory inspections. Primary Duties: Operational… more
- Merck & Co. (Millsboro, DE)
- …dogs, cats, rabbits, and rodents.Assure compliance with all federal and state regulatory requirements for animal welfare, management of controlled substances, ... Job DescriptionAssociate Director , Animal ServicesAbout the JobAnimal Health in Millsboro...other information as needed for annual reports to Federal regulatory agencies. Leadership for internal and external regulatory… more
- Merck & Co. (Rahway, NJ)
- …policy.- The role will also be responsible for proactive resourcing planning, risk assessment strategies and budget management as necessary (including merit ... -The successful candidate will be accountable for proactive resourcing planning, risk assessment strategies and will focus on talent development and partnering… more
- Merck & Co. (Rahway, NJ)
- Job Description Portfolio Customer Experience Execution & Day-to-Day Management : Develop guidance and tools to scale tumor team franchise strategies across multiple ... products Execute GRL interviews to begin change management process and support buy-in Own day-to-day execution with...upskilling to embed critical capabilities (to support the PPS director conduit from HHDDA) on behalf of Global Oncology… more
- Merck & Co. (North Wales, PA)
- …teams, field sales leadership, Vaccines Portfolio Marmeting Team, Integrated Account Management , Learning and Development, Clinical Review Teams, Legal and ... development, including a communication cascade plan in conjunction with Director of Commercial Operations (DCO)Contracting point(s).Collaborate with brand teams to… more
- Merck & Co. (Rahway, NJ)
- …processes/ methods in conformance to all applicable regulatory requirements, regulatory filings and company policies.The Associate Director also ensures that ... Job DescriptionThe Associate Director , ESQL is responsible for all activities at...EQA and Division in specific Quality systems, technology platforms, regulatory expectations and/or EE management , and can… more
- Merck & Co. (Durham, NC)
- …Maintenance, and/or Supply Chain Capital project management experience Risk Management experience Experience supporting regulatory inspections- ... substance manufacturing facility. As a direct report to the Director of Operations, the Associate Director will...regulated manufacturing industry At least two (2) years of management experience Working knowledge of regulatory requirements… more
- Merck & Co. (North Wales, PA)
- …for QMS updates as needed.Support establishment of New Modalities Global Quality Management processes and Regulatory Compliance plan in support of early-stage ... serve our patients. This leader will support the implementation, including change management actions, of the new organization to support a fit-for-purpose quality … more
- Merck & Co. (Rahway, NJ)
- …and knowledge transfer from research to production sitesEnsure knowledge management and process monitoring activities to ensure appropriate process ... regulations, guidelines, and quality standards, including cGMP, FDA, and other regulatory requirements.Safety and Environment: Prioritize and maintain a safe work… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … Affairs, Quantitative Clinical Pharmacology, Clinical Safety and Pharmacovigilance, Regulatory / Risk Management , Quality Assurance, Medical Affairs, ... Translational Research, Research, Informatics Services Project Management and Operational Management .Develop a strong, positive strategic business partnership… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …conduct is completed in compliance and meets Novo Nordisk's business standards Risk management : Assessing and mitigating risks associated with operations, ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...collaborative work culture, including direct partnership with the Operations Director (s) Stakeholder management : Build strong internal and… more
- Eisai, Inc (Nutley, NJ)
- …study teams; Supporting Safety processes, such as Case in-take, Case processing, Risk management and Safety reporting; Business Intelligence technologies such as ... Regulatory and/or Safety functions in a global environment; Supporting Regulatory processes such as Submissions Management , Labelling, Publishing and… more
- Merck & Co. (Rahway, NJ)
- …Pharmacology and Pharmacometrics - Immune/Oncology team in the role of Associate Director . The team is part of the Global Clinical Development organization and ... and effective communication skills. As a subject matter expert, the Associate Director within the Group will work closely with teams of highly collaborative,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Technical Operations team based in Raritan, NJ. Role Overview The Associate Director for Operations Compliance and Investigations Management will provide ... Co-Lead Deviation Investigations: Collaborate closely with the Quality Associate Director to co-lead the deviation investigations management system.… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …quality standards and timelines and that quality of data is suitable for regulatory submission. The Associate Director will have routine interaction with key ... Directive, and International Conference on Harmonization (ICH) guidelines. The Associate Director is accountable for operational planning and execution at the study… more
