- 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
- Merck & Co. (Rahway, NJ)
- …and investment cases to deliver enterprise value, focusing on innovation, risk, regulatory compliance , and scalability. Act as a senior technology business ... Management, Product Management Leadership, Product Strategies, Regulatory Affairs Compliance , Regulatory Compliance , Requirements Management, Stakeholder… more
- Merck & Co. (Rahway, NJ)
- … compliance knowledge and proficiency in interpreting and applying regulatory requirements and guidelines.Ability to travel globally approximately 20-30% of the ... improvement experienceRequired Skills: Audit Readiness, Drug Product Manufacturing, FDA Compliance , FDA GMP, FDA Inspections, FDA Regulatory Requirements,… more
- Merck & Co. (Rahway, NJ)
- …as product lifecycle management for drug-device combination products.Reporting to the Sr. Director of Device Product Assessment & Innovation (DPAI), the Director ... and driving strategic changeExperience with drug-device combination product development, regulatory requirements, and commercialization strongly preferredTrack record of successfully… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionUnder the guidance of the Pneumococcal Vaccines Executive Director , Value & Implementation (V&I) Outcomes Research, the incumbent has the primary ... strategies to ensure that product value is defined and developed. The Director also works closely with Product Development Teams, Franchise Teams, Regional Product… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionUnder the guidance of an Executive Director , within the Value & Implementation (V&I) Outcomes Research team the incumbent has the following ... plans for our company's in-line and developmental products based on the regulatory , marketing and reimbursement environments on a worldwide basis, including the… more
- Merck & Co. (Rahway, NJ)
- …are currently seeking a Cardiovascular & Respiratory Competitive Intelligence Director specializing in PAH, COPD, and other cardiopulmonary diseases. This ... comprehensive understanding of relevant healthcare environment matters, including policy, regulatory , and health technologyDeveloping a global internal network of… 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)
- 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)
- …Programs, FDA Regulations, IT Coordination, IT Operation, Pharmacovigilance, Policy Implementation, Regulatory Compliance , Regulatory Labeling, Regulatory ... 10 years of industry experience, at least 6 of those in a regulatory and/or compliance area and experience with technical systems in a regulated environment OR a… 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)
- …pipeline programs using fed-batch and continuous manufacturing platforms. The Director , Biologics Process Development (BPD) within the Biologics Process Research ... development, tech transfer of clinical or/and commercial processes, and pertinent regulatory filings. The incumbent will be responsible for recruiting, appraising,… 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)
- …executive level and build cross-functional partnerships.Solid understanding of security, compliance and regulatory requirements relevant to payments (PCI-DSS) ... Job DescriptionWe are seeking a seasoned IT SAP Finance Director to lead the design, delivery and continuous improvement of SAP Finance solutions across our… 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)
- …construction and campus planning?- Have you advised on design standards, project scope, and regulatory compliance as well as act as a liaison with internal ... and building design standards, open space and site planning guidelines, and regulatory compliance such as ADA, environmental, and building codes.Ensure quality… more
- Merck & Co. (Rahway, NJ)
- …Logistics, Multiple Therapeutic Areas, Process Optimization, Publications Management, Regulatory Compliance , Risk Management, Sourcing and Procurement, ... (as a lead GCS Planning program representative) such as clinical development, regulatory , quality and other supply chain areas to negotiate timelines, strategies and… more
- Merck & Co. (Rahway, NJ)
- …platforms ensuring internal technical requirements are achieved and ensure filings with regulatory bodies to ensure compliance with relevant regulations and ... Job DescriptionDir, Engineering - Director , Assembly and Packaging Platform Technical LeadershipReporting into the Executive Director Packaging Technical… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Senior Director of Human Factors (HF) will provide visionary leadership and strategic direction for the HF function within our company. This role ... principles to enhance patient safety and product usability. The Senior Director will champion enterprise-wide HF strategy, foster cross-functional collaboration, and… more
