- Eisai, Inc (Nutley, NJ)
- …make a 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 & ... including vendor selection and onboarding Present updates to senior leadership on compliance trends, regulatory changes, and program enhancements C ontribute to… more
- Formation Bio (New York, NY)
- …new treatments to patients faster and more efficiently.About the PositionThe Senior Director , Regulatory Affairs lead is responsible for developing and directing ... the regional regulatory strategy, objectives, policies, and programs pertaining to developing...to all appropriate departments in Formation Bio to assure compliance with applicable regulations. Remains knowledgeable about current regulations… more
- Eisai, Inc (Nutley, NJ)
- …significant clinical pharmaceutical experience (ie, clinical development or operations, regulatory compliance ).Substantial experience in Clinical Quality /CQA ... is responsible for Good Clinical Practice (GCP) and for assuring the compliance of projects, products and programs with Eisai's Standard Operating Procedures (SOPs),… more
- Merck & Co. (Rahway, NJ)
- …to ensure GRACS contractual obligations and commitments are met while maintaining regulatory compliance . - Work closely with the Corporate Business Development, ... Regulatory Affairs, Pharmacovigilance, Regulatory Affairs Compliance , Regulatory Affairs Management, Regulatory Compliance , Regulatory … more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe USDA Compliance Subject Matter Expert (SME) - Associate Director , will report to the Animal Health Global Quality Compliance and Technical ... authority (particularly USDA-APHIS-CVB-IC and/or -PEL) as an inspector, product reviewer, compliance officer, other GMP/ regulatory role or Site Quality Head… more
- Merck & Co. (Rahway, NJ)
- …Research, Mentorship, Plan of Action and Milestones (POA&M), Regulatory Affairs Compliance , Regulatory Compliance {+ 5 more}Preferred Skills: Current ... science that radically changes the way we approach serious diseases. --The Senior Director will report to an Associate Vice President in the Oncology Clinical… more
- Merck & Co. (Rahway, NJ)
- …in alignment with the company's business goals, and quality and regulatory compliance .Essential Duties and Responsibilities:Program Leadership and Technical ... Job DescriptionThe Associate Director - Device Tech Transfer is a leadership role...conducted with the highest regard for safety, quality, and regulatory compliance , aligning with the company's divisional… more
- Merck & Co. (Rahway, NJ)
- …development strategy, study design, initiation, execution, monitoring, analysis, regulatory reporting, and publication.Specifically, the Senior Director ... Job DescriptionThe Senior Director (Sr. Principal Scientist) has primary responsibility for...closely with a cross-functional group of experts in commercialization, regulatory affairs, statistics, and manufacturing to manage clinical development… more
- Merck & Co. (Rahway, NJ)
- …in alignment with the company's business goals, and quality and regulatory compliance .-Essential Duties and Responsibilities:Utilize extensive experience in ... Job DescriptionJob Summary: -The Associate Director of Device Technology is a key leadership...conducted with the highest regard for safety, quality, and regulatory compliance , aligning with the company's divisional… more
- Merck & Co. (Rahway, NJ)
- …in alignment with the company's business goals, and quality and regulatory compliance .-Essential Duties and Responsibilities: Strategic Leadership and Project ... Job DescriptionJob Summary: The Director , Combination Product Commercialization is a key leadership...of team members, fostering a collaborative and innovative team environment. Regulatory Compliance and Quality Assurance: Ensure that… more
- Merck & Co. (Rahway, NJ)
- …hybridization) testing procedures, and applicable laboratory testing regulations.Experience ensuring compliance of a clinical laboratory with regulatory ... Anatomic Pathologist (MD) for the role of Principal Scientist ( Director ) to join our innovative team. This position will...applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los… more
- Merck & Co. (Rahway, NJ)
- …Recruitment, Process Analytical Technology (PAT), Professional Networking, Raw Materials, Regulatory Compliance , Regulatory Submissions, Release Testing, ... entirety of our non-sterile and sterile clinical portfolio. The Director is responsible for ensuring cGMP compliance ...a state of inspection readiness at all times. The Director should be well engaged with regulatory … more
- Merck & Co. (Rahway, NJ)
- …drug substance and drug product container closure systems including mold qualification and regulatory compliance .- To act as master data stewards and support ... Job DescriptionReporting into the Executive Director Packaging Technical Operations the Director ...and continuous improvement initiatives to guarantee the robustness and compliance of our company's product portfolio across the internal… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionReporting into the Director , Logistics and Distribution Technology the Associate Director , Logistics and Distribution Technology will be ... products for the benefit of patients. The Logistics and Distribution Technology Director is integral to this mission. The successful candidate will possess deep… more
- Merck & Co. (Rahway, NJ)
- …Packaging Shipping Systems (Logistics and Distribution Technology)Reporting into the Director Packaging Distribution, Components and Systems COE the Director ... products for the benefit of patients. The Logistics and Distribution Technology Director is integral to this mission. The successful candidate will possess deep… more
- Merck & Co. (Rahway, NJ)
- …development (MIDD) to routinely enable efficient drug discovery/development and/or regulatory decisions. The Pharmacometrics group within QP2 brings an experienced ... pipeline impact and lead a talented group of pharmacometricians.This director will be part of a leadership team responsible...cost/size and number of trials, implementation of tools and regulatory framework for rapid approvals and driving Go/No Go… more
- Merck & Co. (Rahway, NJ)
- …teams, driving the strategy from ideation to value realization.- The Senior Director will: Drives Alignment and Strategic PlanningInspires teams toward shared goals. ... and functional operations to internal teams and external partners Ensures ComplianceOversees compliance of the teams executing processes according to SOP to meet… more
- Eisai, Inc (Nutley, NJ)
- …of GPOs. This is a field-based position that reports to the Director , GPO. Responsibilities: 1. Ownership of Contract Management within assigned GPO member ... business update.Display high level of financial acumen and negotiation skills.Ensure compliance with all laws, regulations and guidelines.Ensure strong and effective… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Principal Scientist/ Director , Value & Implementation (V&I) Outcomes Research, position resides in the V&I organization, which includes Global ... reimbursement and market access, and provides input into clinical, regulatory , payer/access, marketing and evidence generation strategies and programs.In… more
- Merck & Co. (Rahway, NJ)
- …Master Data Management (MDM), Project Management, Project Scheduling, Project Strategy, Regulatory Compliance , Regulatory Requirements, Resource Stewardship, ... Job DescriptionThe Director , Master Data Management (MDM) will lead a...Ensure master data practices comply with internal policies, external regulatory requirements, and audit expectations. Education & Experience :Bachelor's… more
