51 nurse jobs found in Bethlehem, PA

Merck Job Description This position reports to the Associate Director, Global Clinical Supplies Quality, and is critical in maintaining the global clinical supply chain via disposition activities for clinical finished goods provided by our Company for worldwide clinical trials. Specifically, this includes batch documentation review ensuring our clinical supplies are in compliance with current Good Manufacturing Practices (cGMPs) regulations and relevant regulatory filing submissions. Areas of focus of this position revolve around the detailed workings of clinical packaging, labeling and distribution activities and associated regulatory submissions for Investigational New Drug Applications and Clinical Trial Applications in relation to complex/niche supply chains and supply types for clinical protocols as well as Managed Access Programs, Joint Ventures/Collaborations, Independent Investigator-Initiated Studies, etc. Primary duties may include but are not limited to the...

Merck Job Description The Virology (HIV) Regional Medical Scientific Director is a credentialed (i.e., MD, PhD, DNP, Doctoral PA-C, or PharmD) therapeutic and disease area expert who engages in both scientific exchange and research support, when requested, with external scientific leaders and investigators in the medical and scientific community. Virology RMSDs provide Scientific Leaders (SLs) balanced, factual, scientific information about non-product areas of interest to our Company and responds to scientific questions from SLs, including questions about our Company's products and data. Virology RMSDs are responsible for facilitating and developing peer-level relationships with scientific leaders in the external medical/scientific community including those investigators who have potential interest in participating in our Company's research studies. Virology RMSDs provide support for data generation activities including our Company's sponsored trials and our Company's...

Merck Job Description Job Summary This position leads the operational planning and execution of one or more clinical trials or significant aspects thereof. In this position, you will have the opportunity to demonstrate your leadership and technical skills as part of a global, cross-functional team. You will apply project management, communication, and collaboration skills in support of our clinical trials. Job Responsibilities Responsible for the operational planning, feasibility, and execution of a clinical trial.This may include: May serve as the clinical trial team lead May lead team in key study planning, development, and execution elements (e.g., data management deliverables, trial level plans/timelines, country/site selection, site materials, system updates, investigatormeeting planning, communication plans, preparation of status update reports, study close out activities). Leads team for timeline management, risk identification and mitigation,...

Merck Job Description Job Summary This position leads the operational planning and execution of one or more clinical trials or significant aspects thereof. In this position, you will have the opportunity to demonstrate your leadership and technical skills as part of a global, cross-functional team. You will apply project management, communication, and collaboration skills in support of our clinical trials. Job Responsibilities Responsible for the operational planning, feasibility, and execution of a clinical trial.This may include: May serve as the clinical trial team lead May lead team in key study planning, development, and execution elements (e.g., data management deliverables, trial level plans/timelines, country/site selection, site materials, system updates, investigatormeeting planning, communication plans, preparation of status update reports, study close out activities). Leads team for timeline management, risk identification and mitigation,...

Merck Job Description The Vice President, Head of Clinical Safety and Risk Management is an experienced safety physician responsible for leading and overseeing the Clinical Safety and Risk Management (CSRM) department within Global Clinical Safety & Pharmacovigilance (GCS&PV). The CSRM department represents patient safety on Product Development Teams (PDTs), leads the Risk Management and Safety Teams (RMSTs), and is accountable for proactively defining the safety profile, developing effective risk management plans, and ensuring transparent and accurate risk communication for all Company products. The Head of CSRM is accountable to ensure that the team of Physicians, other HCPs and support staff lead the development of worldwide strategies for safety analysis for all products in the Company portfolio. The incumbent is accountable for supervising the assessment by CSRM of safety data from clinical trials and post approval pharmacovigilance, including all aspects...

Merck Job Description The Virology (HIV) Regional Medical Scientific Director is a credentialed (i.e., MD, PhD, DNP, Doctoral PA-C, or PharmD) therapeutic and disease area expert who engages in both scientific exchange and research support, when requested, with external scientific leaders and investigators in the medical and scientific community. Virology RMSDs provide Scientific Leaders (SLs) balanced, factual, scientific information about non-product areas of interest to our Company and responds to scientific questions from SLs, including questions about our Company's products and data. Virology RMSDs are responsible for facilitating and developing peer-level relationships with scientific leaders in the external medical/scientific community including those investigators who have potential interest in participating in our Company's research studies. Virology RMSDs provide support for data generation activities including our Company's sponsored trials and our Company's...

Merck Job Description The Vice President, Head of Clinical Safety and Risk Management is an experienced safety physician responsible for leading and overseeing the Clinical Safety and Risk Management (CSRM) department within Global Clinical Safety & Pharmacovigilance (GCS&PV). The CSRM department represents patient safety on Product Development Teams (PDTs), leads the Risk Management and Safety Teams (RMSTs), and is accountable for proactively defining the safety profile, developing effective risk management plans, and ensuring transparent and accurate risk communication for all Company products. The Head of CSRM is accountable to ensure that the team of Physicians, other HCPs and support staff lead the development of worldwide strategies for safety analysis for all products in the Company portfolio. The incumbent is accountable for supervising the assessment by CSRM of safety data from clinical trials and post approval pharmacovigilance, including all aspects...

Merck Job Description Support the Lead Epi Scientists by providing overall operational support for study conduct. Responsible for the coordination and execution of observational or non-interventional research studies (including Post Authorization studies), in compliance with Good Pharmacoepidemiology Practice (GPP) and Standard Operating Procedures (SOPs). Manages several complex activities and study types. Our Clinical Research and Pharmacovigilance team push the boundaries of global healthcare through research and innovation. Through clinical trials and surveillance, we ensure the safety and efficacy of our existing and pipeline products to produce safe, effective, innovative medicine. Primary responsibilities include: Operational planning and project management of epidemiology research studies Execution, and close out of primary data collection, chart review, database, and molecular epidemiology studies in addition to other activities Manage vendors...

Merck Job Description The Manuals seeks a physician with experience in writing and editing, for the unique position of Physician Editor at The Manuals. This is an opportunity to use your medical knowledge and editorial skills to contribute to medical education and clinical decision support for healthcare professionals, while also providing high quality content for patient education. You would be joining a digital health team that has a global impact. The Manuals' internal editorial team collaborates with over 400 leading academic external authors and editors to provide high quality medical information to professionals and patients. The Manuals, a trusted resource since 1899, is now an innovative digital platform delivered on the web, mobile apps, and through electronic health record integrations to reach a global audience. The Manuals provide free access to medical content translated into 16 languages. A minimum of 5 years clinical experience and demonstrated writing...

CSL Position Description Summary: Responsible for leading the successful operational delivery of global, cross-functional Tech Ops projects of strategic importance to CSL's product portfolio. Main Responsibilities & Accountabilities: Work closely with project leader to define strategy and operational tactics Responsible for the preparation and management of project budgets, sensitivities, resources, project timelines, project scope and all other project documentation Accountable for the accuracy and quality of reports to senior stakeholders Lead cross functional development teams through tactical execution of project plans Identify, manage and resolve project issues and mitigate risks Ensure documentation of key team information, decisions, actions, modifications to scope, resources, timelines and milestones in project management systems is current. Identify, evaluate the critical path, scenarios and challenge assumptions to increase robustness of project plans...

CSL The Opportunity: The Head of Clinical Trial Quality Assurance role maintain and enhance the Global Clinical Trial Quality System supporting Early to Late-stage clinical development projects within R&D, utilizing and improving the existing R&D Quality Management System in alignment with CSL overarching Quality Management System administered and managed by Global Quality. This position strategically oversees aspects of the R&D Quality Management in relation to key quality elements such as Document Management, Knowledge Management, Significant Issue / Serious Breach Management, Deviation and CAPA Management, Risk Management, Continuous Improvement, Inspection Management, Change Management and R&D Quality Governance associated with R&D clinical development. The role manages a Global Clinical quality department supporting early and late-stage clinical trials for all CSL business units across all R&D anchor sites. Develop and maintain an...

CSL Position Description Summary Responsible for leading the successful operational delivery of global, cross-functional R&D projects of strategic importance to CSL's product portfolio. Main Responsibilities & Accountabilities Work closely with project leader to define strategy and operational tactics Responsible for the preparation and management of project budgets, sensitivities, resources, project timelines, project scope and all other project documentation Accountable for the accuracy and quality of reports to senior stakeholders Lead cross functional development teams through tactical execution of project plans Identify, manage and resolve project issues and mitigate risks Ensure documentation of key team information, decisions, actions, modifications to scope, resources, timelines and milestones in project management systems is current. Identify, evaluate the critical path, scenarios and challenge assumptions to increase robustness of project plans...

CSL CSL is a leading global biotechnology company with a dynamic portfolio of lifesaving medicines, including those that treat hemophilia and immune deficiencies, vaccines to prevent influenza, and therapies in iron deficiency, dialysis, and nephrology. Since our start in 1916, we have been driven by our promise to save lives using the latest technologies. Today, CSL - including our three businesses, CSL Behring, CSL Seqirus and CSL Vifor - provides lifesaving products to patients in more than 100 countries and employs 32,000 people. Our unique combination of commercial strength, R&D focus and operational excellence enables us to identify, develop and deliver innovations so our patients can live life to the fullest. Program Experience: CSL's Internship Program is a hands-on experience that showcases the daily innovation and operations of a leading biotechnology company. Our environment is collaborative, global, and purpose-driven. The 12-week experience will immerse...

CSL This position will lead the transformation of project leadership capabilities across the R&D enterprise. On a systemic level, this role will prepare critical GPL roles (Exec Directors) to be CEO of the project via a bespoke leadership/drug development/executive training and coaching program which will equip these leaders and associated project teams to navigate ambiguity, prioritize effectively, and make high-impact R&D investment decisions that accelerate innovation and deliver value to patients. This position will work with the CEO/GLG, RDLT and all levels to ensure the Project Operating Model is continuously improved for simple, rapid, empowered, project-centric decision making at the right level. This role will also lead the leadership development of Project Managers (PMs) and Research Project Leads (RPLs) in R&D and strengthen the GPL/GPM partnership. Main Responsibilities & Accountabilities *Develop and run an executive...

CSL The Lead, Global Regulatory Affairs Device is responsible for: Developing, coordinating and implementing global Software as a Medical Device regulatory strategies for new combination and standalone medical devices. Ensure worldwide regulatory device compliance and successful market access across all regions. Closely collaborate with internal stakeholders on regulatory strategy issues, develop approaches to address regulatory and compliance matters, serve as primary liaison to the US FDA for device matters, and closely work regional regulatory staff to engage with international health authorities. Represening CSL in official device regulatory capacities and acting as an authorized official or responsible person in interactions with regulatory agencies. This role promotes strong cross-functional collaboration and effective communication across Global Operations, Plasma Operations, R&D, Global Regulatory Affairs, and other relevant CSL business functions to...

CSL The Lead, Global Regulatory Affairs Device is responsible for: Partnering closely with R&D, Manufacturing, Operations, Quality, and Regulatory Affairs stakeholders to address regulatory strategy challenges and deliver innovative, timely regulatory solutions that meet evolving device regulatory and compliance requirements for plasmapheresis devices, drug device combination products, standalone drug delivery devices, and ancillary devices. Ensure worldwide regulatory device compliance and successful market access across all regions. Closely collaborate with internal stakeholders on regulatory strategy issues, develop approaches to address regulatory and compliance matters, serve as primary liaison to the US FDA for device matters, and closely work regional regulatory staff to engage with international health authorities. Represening CSL in official device regulatory capacities and acting as an authorized official or responsible person in interactions with...

CSL The Senior Manager, R&D Outsourcing is responsible for managing the full contracting lifecycle for strategic outsourced R&D services and projects across assigned therapeutic and functional areas. This includes drafting, reviewing, and negotiating scopes of work, budgets, and contracts with external service providers to support CSL's global clinical and portfolio development needs. This individual contributor role partners closely with Business Strategy Leads, Project Owners, Legal, Finance, and Procurement to ensure timely contract execution, cost control, and compliance with CSL's policies and standards. Outsourcing Execution Manage vendor identification, RFI/RFP processes, proposal reviews, and budget and contract negotiations for strategic outsourced R&D services (e.g., MSAs, Work Orders, Change Orders, rate cards). Draft, review, and finalize contracts to ensure timely execution and compliance with CSL policies. Coordinate with project teams and...

CSL Position Purpose The Head of Global Regulatory Affairs Device is responsible for: Providing strategic leadership and operational oversight for the Global Regulatory Affairs Device function. Leading the global regulatory strategy and execution for CLS's medical device portfolio during development and post-approval lifecycle, including plasmapheresis devices, blood establishment computer software (BECS), drug device combination products, standalone drug delivery devices, ancillary devices, and software as/in a medical device (SaMD/SiMD). Ensure worldwide regulatory device compliance and successful market access across all regions. Closely collaborate with internal stakeholders on regulatory strategy issues, develop approaches to address regulatory and compliance matters, serve as primary liaison to the US FDA for device matters, and closely work regional regulatory staff to engage with international health authorities. Represening CSL in official...

CSL The Global Regulatory Affairs CMC - Decision Support Lead is responsible for: Providing comprehensive administrative support to the Head of Global Regulatory Affairs CMC to enable the Head of Global Regulatory Affairs CMC to focus on strategic priorities and organizational leadership. This role requires exceptional attention to detail, strong communication skills, maintaining the highest level of confidentiality, and the ability to manage multiple priorities simultaneously. Providing targeted administrative support to the Global Regulatory Affairs CMC leadership team, ensuring the efficient operation of departmental activities. Tracks departmental business actions, goals, objectives, KPIs, and commitments to internal stakeholders. Supports the Head of Global Regulatory Affairs CMC in department-wide resource planning and forecasting through data-driven resource analysis. Partners with finance, HR, and project managers to support workforce planning, hiring...

CSL Reports to: Associate Director, Clinical Trial Business Operations Position Summary The Senior Manager, Clinical Trial Business Operations (CTBO) oversees CRO execution of investigator site budgets, contracts, site payments, and ICF deliverables. This role is also responsible for coordinating clinical trial insurance needs and supporting Sunshine Act/transparency reporting requirements. The Senior Manager ensures operational consistency, manages escalations, and contributes to compliance, quality, and governance activities. Key Responsibilities CRO Oversight Review and oversee CRO work related to budgets, contracts, payments, and ICFs. Ensure accuracy, quality, and alignment with internal templates, processes, and parameters. Provide operational guidance to CRO teams to ensure consistency across regions and studies. Escalation & Issue Management Manage escalations exceeding CRO negotiation authority. Partner with Clinical Operations,...