- RIT Solutions, Inc. (Wayne, NJ)
- …CCAR, FR2052A or deployment of new Regulatory Reporting solutions with a focus on data quality , controls, and overall governance of the production of regulatory ... Title: Program Director of Regulatory Reporting - Must have current...advancement of the streams to the steering committee and senior management, lerts senior management in case… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionUnder the direction of a HEDS Executive Director , the Senior Principal Scientist, Health Economics leads a team of health economists and outcomes ... economists and outcomes researchers.Accountable for team prioritization and development of high- quality health economic models and tools to support market access,… more
- Merck & Co. (Rahway, NJ)
- …data /medical protocol deviations in collaborations with the Clinical Director . Other responsibilities include: Collaborating cross-functionally in the development ... collaboration with Data Management/Programming. Collaborating cross-functionally to monitor clinical data -to ensure quality , completeness , and integrity of… more
- Formation Bio (New York, NY)
- …to patients faster and more efficiently.About the PositionWe are seeking a Senior Director , Biologics to lead all Chemistry, Manufacturing, and Controls ... in scaling our biologics capabilities in partnership with technical, quality , and regulatory leaders.Responsibilities Strategic Leadership Develop and execute… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Summary: The Senior Director , Head of RBQM (Risk Based Quality Monitoring) sets the vision and ... within R&D. Reviews and provides guidance to RBQM projects. Accountable for the quality and timeline for all RBQM deliverables. Promotes, oversees and is accountable… more
- Merck & Co. (Rahway, NJ)
- …- Associate Principal Scientist, CMC, R4 - Pharm Pre-approval Reporting to the Sr Director / Director /Principal Scientist/ Sr Principal Scientist in ... pharmaceutical operations (eg, manufacturing, formulation and process development, analytical, quality assurance, n ovel modality and technologies such as synthetic… more
- Formation Bio (New York, NY)
- …obligations to maximize service quality and efficiency. Partner with Legal, Quality Assurance and Data Governance teams to understand and monitor vendor ... bring new treatments to patients faster and more efficiently.About the roleThe Director , Procurement will be responsible for establishing and managing a strategic… more
- Merck & Co. (Rahway, NJ)
- …integrating state-of-the-art technology and applying rigorous scientific and ethical standards.The Senior Director has primary responsibility for the planning ... teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new drugs,...to post-licensure). With a focus on late-stage development, the Senior Director will manage the entire cycle… more
- Merck & Co. (Rahway, NJ)
- …portfolio. Within Biologics and Biopharmaceutics, the large molecule product development Director will influence the strategy, lead activities, and develop a team ... / our Research & Development Division ) such as Quality , Regulatory CMC, and technical functions, to ensure timebound...and collaboration with various partners and stakeholders in development.The Director will report to the Executive Director … more
- Merck & Co. (Rahway, NJ)
- …a lead GCS Planning program representative ) such as clinical development, regulatory, quality and other supply chain areas to negotiate timelines ,- strategies and ... both technical & business risks, & influence portfolio decisions with facts and data Demonstrates ability to balance strategy with ability for tactical execution and… 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 ... and downstream processes that produce high yields along with superior product quality and allow speedy progression for clinical studies and commercial launch. The… more
- Merck & Co. (Rahway, NJ)
- …Operations, Drug Delivery Systems and Devices within our Manufacturing Division (Associate Director ).-This role serves as a Virtual Plant Manager - responsible for ... Biologic, and Vaccine Products. Our team works with a "Safety First, Quality Always" mindset.-As the primary point of contact for all dealings between… more
- Merck & Co. (Rahway, NJ)
- …/medical protocol deviations in collaborations with the Clinical Director .Other responsibilities include:Collaborating cross-functionally in the development of ... collaboration with Data Management/Programming.Collaborating cross-functionally to monitor clinical data to ensure quality , completeness, and integrity of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to Biostatistics Data Management & Data Ops for EDC, edit checks, data quality listings, SAP, Data Management plan; Reviews patient population and ... to ensure appropriate biomarker, PK / PD measurements; Reviews emerging clinical data regularly; Leads dose-escalation meetings; Performs quality assessment with… more
- Citigroup, Inc. (Rutherford, NJ)
- …Technology (ERT) within Functions Technology (FT) provides solutions and support to Senior risk management team who manages firm-wide enterprise Risk & control ... across multiple risk categories. This role is a senior management level position as the Engineering Software Manager within Enterprise risk management technology.… more
- Merck & Co. (Rahway, NJ)
- …Methodologies (separation-based and residuals) and sound scientific understanding of Critical Quality Attributes/QbD/DOE principles as well as data analysis and ... New Jersey research facility. The Principal Scientist is a senior scientific role tasked with working closely with the...scientific role tasked with working closely with the group Director to define group strategy and to lead a… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …4+ years of proven leadership experience managing technical and validation teams, preferably at Director or Senior Management level - Required 7+ years of strong ... meet strict regulatory requirements, industry best practices, and internal quality standards. The Lead is responsible for defining and...21 CFR Part 11, Annex 11, GAMP 5, and data integrity - Required Deep understanding of IT system… more
- S&P Global, Inc. (New York, NY)
- …and Publishing team within the analytical engineering portfolio. This is a senior leadership role, and is critical in driving the architecture, scalability, and ... "value streams" and partner with your Product Management and Quality peers to support a large, global group of...engineering experience with at least 4 years in a senior leadership role managing engineering managers and cross-functional teams.… more
- Aetion (New York, NY)
- …real world data , as well as R programming and managing teams. As a Senior Director in the Research+Analytics team, you will hold an active people manager ... agreement to be acquired by Datavant, a leading health data platform company. Learn more. PERKS of being an...Aetion contributions. Free membership to OneMedical Peer & company recognition programs Educational lunch & learns DESCRIPTION: As a… more
- BBYO (New York, NY)
- …reimagine work to make it fun, flexible, and fulfilling. We are looking for a passionate Senior Regional Director to join our New York City team and make a ... difference. As a Senior Regional Director , you'll play a pivotal...and teens to implement a calendar of impactful, high quality , fun and dynamic programs. Mentoring teens and providing… more
