- Novo Nordisk Inc. (Plainsboro, NJ)
- …Position Reporting to the head of Clinical, medical, Regulatory (CMR) Business Operations , the Associate Director (AD) is responsible for structuring ... key internal stakeholders. In the execution of specific projects, the Associate Director, will be accountable for managing relationships with internal stakeholders… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …to the Director, People Operations within the Strategy & People Operations team. The Associate Manager Operational Efficiency role directly collaborates with ... teams to lead through process mapping for P&O. Streamlining operations and leveraging efficiencies for the way we work...across the team. Relationships The Associate Manager Operational Efficiency reports… more
- Merck & Co. (Rahway, NJ)
- …for Life" Objective. The Global Engineering Solutions (GES) group is seeking an Associate Director of Engineering to manage a significant portion of a very large ... mitigationManaging/ implementing commissioning, qualification, contract administration and project close-out.The Associate Director, Engineering will strive to develop good relationships… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionPosition Description:Reporting to a Technology Director or Associate Director in Global Engineering Solutions (GES), the Associate Director will ... portfolio of Large Molecule, Small Molecule, and Animal Health work.The Associate Director participates in project activities ranging from business case development… more
- Merck & Co. (Rahway, NJ)
- …individual to join our Downstream Process Development and Engineering group as an Associate Principal Scientist.- In this role, you will work with a highly ... and activities include designing and optimization of downstream unit operations such as cell harvest, filtration, chromatography, viral clearance, precipitation,… more
- Insmed Incorporated (New York, NY)
- …Insmed.Support research and development programs as requested by R&D, Clinical Operations , and Medical Affairs Departments. This may include trial site ... identification, ongoing recruitment motivation, and issue/problem solving.Provide medical and scientific support to payers, commercial managed markets, and related health care organizations to facilitate access to Insmed's medications for appropriate patients.… more
- Merck & Co. (Rahway, NJ)
- …innovation and interest in contributing to upstream and/or downstream bioprocessing.As an Associate Scientist in BPD you will work with a highly collaborative team ... drug substanceIndependently design and conduct experiments for individual unit operations using relevant operational parameters and analytical inputsIntegrate unit … more
- Merck & Co. (Rahway, NJ)
- …goals; others that are directly linked with execution of strategic goals. Operations Target : Drive ongoing procurement activities pursuant to transactions and ... projects not in connection with SMP or strategy creation/execution. This is the "keep the lights on" and it is normally driven by daily/weekly requests from the business and procurement. Typical Activities : Contract review/negotiations; PO issue resolution;… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionJob Overview:-We are seeking a highly qualified and experienced Associate Director in Data Management to lead our data management team in supporting ... excellence and enhance the efficiency of our clinical research operations .Key Responsibilities:- Lead Data Management Initiatives:-Direct the development and… more
- Merck & Co. (Rahway, NJ)
- …support, familiarity with manufacturing batch record reviews and/or operations .Experience with mathematical modeling, theoretical scaling calculations, drug ... substance comparability, scale down establishment, computational fluid dynamics (CFD) modeling, Quality by Design (QbD) and Lean Six Sigma principles. Experience supporting/writing regulatory filings (IND, MAA, BLA) and inspections with multiple agencies (FDA,… more
- Merck & Co. (Rahway, NJ)
- …practices related to clinical supply planning and incorporate them into the team's operations . - Focus on Customers & Patients. - Make rapid, disciplined decisions. ... - Demonstrates Ethics & Integrity. - Required Experience and Skills:- - Bachelor's degree in a scientific, business, or related discipline required , MS/MBA preferred . - At least 8 years of experience in project management . - - At least 5 years of experience… more
- Merck & Co. (Rahway, NJ)
- …disciplines: Knowledge of IAM, Network Security, Endpoint Security, Security Operations , Risk and complianceStrong Grasp of Architectural Principles and ... Technologies: Deep familiarity with modern architectural methodologies including serverless architectures, microservices, and the principles of DevSecOps. Ability to leverage these technologies to deliver innovative and effective security solutions that align… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …for professional and personal development. Are you ready? The Position The Associate Director, Communication Ops is responsible for driving cohesive messaging and ... Relationships This position reports to the Director of People Operations and sits within the larger Strategy & People... and sits within the larger Strategy & People Operations team. This position interacts and supports P&O COEs… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of clinical studies, under the supervision of the Study Manager role the Study Associate Manager within Clinical Operations , in adherence to the protocol, Good ... evaluating study budgetsCollect information and coordinate with DS Regulatory Operations to post trial information on required public forums… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …in support of Phase I-III clinical studies.Partner with Project Management, Clinical Operations and other functional groups to ensure budgets are always maintained ... for the development and control of functional budget in support of global operations of RD unit.Partner with global function leaders to ensure budgets are always… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …establish the strategy driving global Clinical Study Start-Up activities for PV Safety Operations . This position oversees the creation of SAE Flow Plans and may ... activities. This position will interact with global study teams and represent PV operations in global interactions with CS Physicians and other study team members.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …growth. These responsibilities will include management of all day-to-day payroll operations and activities for all US (multi-state) and Canada regions, ensuring ... the candidate possesses significant domain experience with the DSI payroll operations preferred- ADP Vantage Certifications preferred Experience Qualifications- 7 or… more
- Merck & Co. (Rahway, NJ)
- …have 10-15 direct reports composed of experienced, senior and associate scientists.- The successful candidate will effectively partner with Biologics ... and partnering for Pharmaceutical development/ CMC with Quality, Regulatory, Operations , Non-clinical, Clinical, and other functional areasExperience with regulatory… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …The Position We are seeking a dynamic and experienced Regulatory Affairs Labeling Associate Manager to oversee and lead critical tasks related to final printed ... Marketing and Supply Chain. Relationships Reports to labeling management in Regulatory Operations (RO), engaging with key company personnel within Novo Nordisk Inc.,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and tracking of labeling milestones. Collaborates with Global Labeling Operations and Compliance Leads to produce high quality labeling documentation.Establishes ... Processes and Best Practices: Reinforces labeling best practices at cross-functional meetings. Assists in the development of Standard Operating Procedures (SOPs) and process improvements. Follows agreements with external partners.Department Coordination:… more
