- Merck & Co. (South San Francisco, CA)
- …to ensure alignment with clinical development timelines and regulatory requirements . Most importantly, the role requires overseeing CDx development, ensuring ... stay up to date regarding industry trends and diagnostic regulatory requirements . Essential Job Requirements :Develop end-to-end diagnostic strategy in… more
- Merck & Co. (Millsboro, DE)
- …all regulatory agencies and corporate policies.Evaluate personnel and machinery requirements and make and/or implement recommendations for changes and ... improvementsParticipation in daily activities to understand requirements and issuesCoordination with vendors to determine equipment options.Assist in procurement and… more
- Merck & Co. (Rahway, NJ)
- …functions.Lead the Device Engineering Sub-Teams focused on development of design requirements for the combination product and engineering execution against the ... established requirements .Represent Device Development & Technology and the project-specific Combination Product Working Groups on cross-functional teams at the… more
- Merck & Co. (Rahway, NJ)
- …manufactured in accordance with regulatory, company, and customer requirements .- -Principal ResponsibilitiesLead/contribute to device development, design controls ... Development and with external suppliers.Understand and apply regulatory / compliance requirements relative to design controls and risk management activities.Lead the… more
- Merck & Co. (Rahway, NJ)
- …oncology. -The senior statistical programmer will gather and interpret user requirements for analysis and programming requests in close collaboration with ... non-standard data in a variety of formats with minimal requirements ; knowledge of pharmaceutical development processesEfficiently manipulates very large databases… more
- Merck & Co. (Rahway, NJ)
- …to perform the above duties and to develop the above capabilities. Minimum Education Requirements :Ph.D. with 8+ years industry experience, MS with 10+ years, or BS ... filings, and demonstrated working knowledge of FDA, ICH, and other regulatory requirements for CMC.- Strong understanding of integration and partnering with Quality,… more
- Merck & Co. (Durham, NC)
- …with current good manufacturing procedures(cGMP), safety and environmental requirements /regulations/guidelinesThe ability to follow complex instructions and use our ... Manufacturing Division business systems (SAP, ADP eTime, etc.)Physical requirements - Must be able to lift 50 lbs, climb ladders and stairs, work on platforms and… more
- Merck & Co. (Rahway, NJ)
- …working with CMOs and CROs.Have a working knowledge of CMC filing requirements .Demonstrate strong verbal as well as written communication skills and ability to ... characteristics.--As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.- For more… more
- Merck & Co. (Durham, NC)
- …with current good manufacturing procedures(cGMP), safety and environmental requirements /regulations/guidelinesThe ability to follow complex instructions and use our ... Manufacturing Division's business systems (SAP, ADP eTime, etc.)Physical requirements - Must be able to lift 50 lbs, climb ladders and stairs, work on platforms and… more
- Merck & Co. (Rahway, NJ)
- …drugs that incorporate the latest scientific developments, regulatory requirements , the competitive landscape, and commercial considerations;Planning clinical trials ... characteristics.--As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.- For more… more
- Merck & Co. (Rahway, NJ)
- …Users of the Systems and the associated IT Partners for defining Business Requirements and ensuring the system is aligned to meet the business needs.Facilitate ... collaboration with IT Business Partners including activities relating to Requirements Gathering, Documentation, Testing, Implementation, Deployment and Hypercare phases.Facilitate… more
- Merck & Co. (Durham, NC)
- …must complete and be medically cleared for BCG medical clearance requirements : questionnaire, blood test, chest x-ray Position Responsibilities:This role reports to ... on the process for daily work and projects, understand full process requirements such as safety, compliance, processProviding guidance for daily production support,… more
- Merck & Co. (Rahway, NJ)
- …interaction with customers and stakeholders to gather and understand site business requirements and provide feedback into our company's Global Data Center strategic ... operating and supporting enterprise DC environments with 24x7x365 uptime requirements .5+ years' experience designing and deploying Technology Spaces supporting… more
- Merck & Co. (Boston, MA)
- …characteristics.--As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.- For more ... work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model… more
- Merck & Co. (Rahway, NJ)
- …audit cycles for management.Support the Compliance team with FIN 48 reporting requirements and related documentation.Conduct research on tax laws and regulations to ... characteristics.--As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.- For more… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and ensures compliance against health authority regulations and Novo Nordisk requirements in relation to Pharmacovigilance (PV) oversight. This role fulfills the ... processes while striving for simplicity and ensuring adherence to regulations and requirements . Communicate direction on a range of uniquely complex issues in a… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and ensures compliance against health authority regulations and Novo Nordisk requirements in relation to Pharmacovigilance (PV) oversight. This role fulfills the ... (eg training program, FAQs) to enable compliance with QMS process requirements across NNI and global as applicable Proactively identifies risks/quality drift… more
- Merck & Co. (North Wales, PA)
- …computing software and data management; a general understanding of worldwide regulatory requirements ; and with good clinical trial experience in Phase II/ III ... bias, contain maximum information (minimum variance), and satisfy analysis requirements .5. Determines the statistical programming needs and organizes the programming… more
- Merck & Co. (Durham, NC)
- …Database SystemsEffective maintenance, troubleshooting, and problem-solving skills requiredPhysical requirements - Must be willing and able to lift ... characteristics.--As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.- For more… more
- Merck & Co. (Rahway, NJ)
- …portfolio while developing new ways of working to meet aggressive timeline requirements and integrate within the broader parenteral portfolio, where appropriate. The ... for the Director Include:Sterile drug product development concepts, tools, and requirements for all dosage forms (liquid, lyo, drug-device combinations)Review and… more
