- Daiichi Sankyo, Inc. (Bernards, NJ)
- …access programs.Partner with Medical Affairs to facilitate the implementation of a risk -based quality management process fully embedded through trial design, ... Commitments, Critical Incidents including, respective escalation and the CAPA Management Process for the respective business areas.Responsibilities:Leadership… more
- Merck & Co. (Rahway, NJ)
- …Description: Our Research and Development Division's microbiology team is seeking a Director for the Rahway NJ GMP microbiology operations.- The primary objective of ... oversee GMP environmental monitoring and microbiological release of pipeline products.- The director will provide guidance, lead activities, and strengthen a team of… more
- Merck & Co. (Rahway, NJ)
- …extensive experience in design controls, device transfer, control strategies device risk management , and design verification testing to developvalue-added ... Job DescriptionThe Associate Director - Device Tech Transfer is a leadership role...for providing strategic program leadership, technical expertise, and project management in the scale-up, development,commercialization, and transfer of medical… more
- Merck & Co. (Rahway, NJ)
- …extensive experience in design controls, device transfer, control strategies device risk management , and design verification testing to develop value-added ... leading combination product development teams and working groupsPSCSRequired Skills: Business , Management Process, Social CollaborationPreferred Skills: Current… more
- Merck & Co. (Rahway, NJ)
- …extensive experience in design controls, device transfer, control strategies, device risk management , and design verification testing to develop value-added ... Job DescriptionJob Summary: -The Associate Director of Device Technology is a key leadership...robustness for sustained launch in alignment with the company's business goals, and quality and regulatory compliance.-Essential Duties and… more
- Merck & Co. (Rahway, NJ)
- …The role will also be responsible for proactive resourcing planning, risk assessment strategies, and budget management as necessary.Primary Responsibilities: ... Job DescriptionRaw Materials & Medical Device Director , Small Molecule Analytical Research & Development The Small Molecule Analytical Research and Development… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and external vendors/contractors Ensure seamless operations and timely delivery of safety data Risk Management Act as the primary point of escalation for Medical ... you ready to make a difference? The Position The Director Medical Review oversees a team of Medical Reviewers...Team. Relationship Reports directly to Head of PV Case Management . This role involves the oversight of case handling… more
- Merck & Co. (Rahway, NJ)
- … Management , Pharmaceutical Process Development, Process Scale Up, Program Risk Management , Project Planning, Protein Characterization {+ 2 more}Preferred ... pipeline programs using fed-batch and continuous manufacturing platforms. The Director , Biologics Process Development (BPD) within the Biologics Process Research… more
- Insmed Incorporated (NJ)
- …impact public company reporting and internal controls.While Compliance maintains broadly Enterprise Risk Management (ERM), Internal Audit will perform a critical ... of SOX requirements, internal control framework (COSO), GAAP and risk management methodologies.Excellent analytical, problem-solving and critical thinking… more
- Eisai, Inc (Nutley, NJ)
- …Agility, Drafting and Negotiation, Industry/ Regulatory Knowledge, Legal & Reputational Risk Management , Mentoring/ People Development, Stakeholder Management ... difference. If this is your profile, we want to hear from you. The Associate Director , Compliance Operations will be a key member of Eisai's US Ethics & Compliance… more
