35 jobs found in Rahway

Merck Job Description This position contributes to the operational planning and execution of one or moreclinical trials. In this position, you will have the opportunity to develop your leadershipand technical skills as part of a global, cross-functional team. You will applyproject management, communication, and collaboration skills in support of our clinical trials. Job Responsibilities: May have specific operational responsibilities for a single study or across multiple studies (e.g., operational deliverables, clinical & ancillary supplies planning/tracking, lab specimen tracking, status update reports, study closeout activities). May be responsible for tracking study timelines using project management tools. Shares technical expertise with team members. May interact with internal and external stakeholders (e.g., study team, vendors, committees) in support of clinical trial objectives. Education Requirements: Bachelor's degree with two (2)...

Merck Job Description SENIOR SPECIALIST (P-3),Audit and Assurance Services Our company's Audit and Assurance Services primary purpose is to provide value-added independent and risk-based audit and assurance services. Position Overview / Function and Responsibility Under the direction of the Client Audit Director ("CAD") and the Auditor-in-Charge ("AIC"), the Senior Specialist will: Participate in the execution of financial, operational, SOX 404 and IT audits, integrated and process audits, both domestic and abroad to ensure a strong internal control environment is maintained at our company. On occasion, will be expected to lead small teams of auditors. Under the direction of the AIC, partner with colleagues and clients and other organizations to effectively complete all assigned audit work. Execute audit programs and work papers (including walkthroughs and sample testing) in line with the established quality standards and timelines. Present audit...

Merck Job Description The Senior Clinical Director (Senior Principal Scientist) has primary responsibility for planning and directing clinical research activities involving new or marketed medicines in the Oncology therapeutic area. Our company's Oncology medicines span all phases of clinical development (pre-clinical to post-licensure). The Senior Clinical Director may manage the entire cycle of clinical development for their assigned studies including study design, initiation, execution, monitoring, analysis, regulatory reporting, and publication. Role Responsibilities: Specifically, the Senior Clinical Director may be responsible for: Evaluating pre-clinical and translational work for the purpose of generating early clinical development plans and Investigational New Drug applications Developing clinical development strategies for investigational or marketed drugs in Endometrial Cancer Planning clinical trials (designing, collaborating on operational...

Merck Job Description The Sterile Product Development (SPD) group is responsible for developing non-oral dosage forms (injections, implants, inhaled, ocular) for small, intermediate, and large molecules from preclinical toxicology studies to commercialization. Our development teams ensure robust composition, primary packaging/device, and process selection through deep fundamental understanding and characterization such that the process is scalable without compromising stability, safety, efficacy, and delivery. During development, we leverage smart experimental design, cutting edge analytical tools, and predictive approaches to inform molecule, formulation and process selection. In summary, our team enables the translation of preclinical candidates into non-oral drug products. Our team is looking for a strong candidate for the position of Principal Scientist (R5) within the Biologics product development group. Primary duties: Be a seasoned biologics product developer...

Merck Job Description As the Director, Primary Market Research for Oncology, you will join a team of passionate, data-driven strategists who partner with stakeholders at local, regional and global levels to enable value-driven decision making. You will lead and coach a team of market research professionals (both US based and indirect team members based in India) responsible for planning, prioritizing, managing and executing work across the therapeutic area spanning pre- and post-launch, as well as future assets. You will manage a diverse set of stakeholders at all levels and collaborate closely with peers in the Primary Market Leadership team and across the Digital Human Health (DHH) organization. Your Market Research and Analytics expertise will position you as a strategic partner who proactively engages cross-functional brand teams to address key business questions. You will be an exceptional leader and active member of the Primary Market Research leadership team. You...

Merck Job Description Associate Principal Scientist, Small Molecule Analytical Research & Development The Small Molecule Analytical Research and Development (SMAR&D) group has an exciting opportunity for an Associate Principal Scientist based in Rahway, NJ. Join us and experience our culture firsthand - one of strong ethics & integrity, diversified experiences, exceptional science and a resounding passion for improving human health through innovative drug delivery technologies and predictive analytical tools. As part of our global team, you will have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career. As an Associate Principal Scientist, you will be part of a team developing innovative analytical methodologies for medicines based on small molecules, peptides, mRNA, oligonucleotides and bioconjugates. Our responsibilities range from early stage up to commercialization for both drug substance and...

Merck Job Description GRACS (Global Regulatory Affairs & Clinical Safety) CMC - Associate Principal Scientist, CMC - Pharm Pre-approval (Respiratory/Inhalation Products) This Associate Principal Scientist in Pre-approval Pharmaceutical CMC will be responsible for developing and implementing CMC regulatory strategies for our Company's pharmaceutical pipeline products in accordance with global regulations and guidance's, with a focus on small molecule respiratory/inhalation product development. Position will support respiratory/inhalation and some conventional small molecule programs and isresponsible for the preparation and submission of CMC dossiers. Primary responsibilities include, but are not limited to: Regulatory CMC responsibilities: Serve as a CMC Product Lead for assigned products and be accountable for the delivery of all regulatory milestones through product & device development requirements and strategies including assessment of the probability of...

Merck Job Description The Rahway based Senior Specialist, Global Development Quality Operations , is responsible for independent approval of documentation to support GMP clinical supply drug product manufacture, testing, release, and maintenance in support of our company's clinical supply programs. This person will also independently approve documentation accompanying the disposition of excipients, components, and critical supply items to ensure conformance to appropriate regulatory and company requirements. In support of clinical supply manufacture and/or regulatory inspections independently perform or coordinate routine and specialized audits of batch documentation, data, information, procedures, equipment and systems, and/or facilities to ensure compliance with Standard Operating Procedures (SOPs), Good Manufacturing Practices (GMPs) and other applicable worldwide regulations and our company's requirements. Issue reports summarizing results and work with area to ensure...

Merck Job Description Job Description: In BARDS (Biostatistics and Research Decision Sciences), a distinguished department within our renowned Research and Development division, quantitative scientists, in partnership with other subject matter experts, apply state-of-the art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for the benefit of patients and global human health. Responsibilities: The Senior Statistical Programmer, Submission Data Standards Quality Management (SDS QM), provides oversight and quality management of submission data standard deliverables for world-wide regulatory application submissions of drug and vaccine clinical development projects. Accountability predominantly includes submission data standards planning activities, coaching and consulting with project teams, outreach to external vendors and partners, and keeping current with industry...

Merck Job Description GRACS CMC - Principal Scientist, CMC, - Pharm Pre-approval (Inhalation/Respiratory Franchise) Reporting to the Ex-Director/ Sr. Director in Pre-approval Pharmaceutical CMC is responsible for developing and implementing CMC regulatory strategies for our Company's pharmaceutical pipeline products in accordance with global regulations and guidance's, with focus on small molecule respiratory/inhalation product development. Position will primarily lead oversight of multiple programs in Respiratory franchise and some conventional small molecule programs. Primary responsibilities include, but are not limited to the following: Primary Responsibilities Provide regulatory leadership, oversight, and strategy to a team of Regulatory CMC Professionals in developing global Regulatory CMC strategy and executing submissions related to small molecule, development products. This includes preparation of applicable IND/CTA's, Agency Background Packages,...

Merck Job Description Job Description: In BARDS (Biostatistics and Research Decision Sciences), a distinguished department within our renowned Research and Development division, quantitative scientists, in partnership with other subject matter experts, apply state-of-the art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for the benefit of patients and global human health. Responsibilities: The Senior Statistical Programmer, Submission Data Standards Quality Management (SDS QM), provides oversight and quality management of submission data standard deliverables for world-wide regulatory application submissions of drug and vaccine clinical development projects. Accountability predominantly includes submission data standards planning activities, coaching and consulting with project teams, outreach to external vendors and partners, and keeping current with industry...

Merck Job Description The Senior Clinical Director (Senior Principal Scientist) has primary responsibility for planning and directing clinical research activities involving new or marketed medicines in the Oncology therapeutic area. Our company's Oncology medicines span all phases of clinical development (pre-clinical to post-licensure). The Senior Clinical Director may manage the entire cycle of clinical development for their assigned studies including study design, initiation, execution, monitoring, analysis, regulatory reporting, and publication. Role Responsibilities: Specifically, the Senior Clinical Director may be responsible for: Evaluating pre-clinical and translational work for the purpose of generating early clinical development plans and Investigational New Drug applications Developing clinical development strategies for investigational or marketed drugs in Endometrial Cancer Planning clinical trials (designing, collaborating on operational...

Merck Job Description The Rahway based Senior Specialist, Global Development Quality Operations , is responsible for independent approval of documentation to support GMP clinical supply drug product manufacture, testing, release, and maintenance in support of our company's clinical supply programs. This person will also independently approve documentation accompanying the disposition of excipients, components, and critical supply items to ensure conformance to appropriate regulatory and company requirements. In support of clinical supply manufacture and/or regulatory inspections independently perform or coordinate routine and specialized audits of batch documentation, data, information, procedures, equipment and systems, and/or facilities to ensure compliance with Standard Operating Procedures (SOPs), Good Manufacturing Practices (GMPs) and other applicable worldwide regulations and our company's requirements. Issue reports summarizing results and work with area to ensure...

Merck Job Description Associate Principal Scientist, Small Molecule Analytical Research & Development The Small Molecule Analytical Research and Development (SMAR&D) group has an exciting opportunity for an Associate Principal Scientist based in Rahway, NJ. Join us and experience our culture firsthand - one of strong ethics & integrity, diversified experiences, exceptional science and a resounding passion for improving human health through innovative drug delivery technologies and predictive analytical tools. As part of our global team, you will have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career. As an Associate Principal Scientist, you will be part of a team developing innovative analytical methodologies for medicines based on small molecules, peptides, mRNA, oligonucleotides and bioconjugates. Our responsibilities range from early stage up to commercialization for both drug substance and...

Merck Job Description GRACS CMC - Principal Scientist, CMC, - Pharm Pre-approval (Inhalation/Respiratory Franchise) Reporting to the Ex-Director/ Sr. Director in Pre-approval Pharmaceutical CMC is responsible for developing and implementing CMC regulatory strategies for our Company's pharmaceutical pipeline products in accordance with global regulations and guidance's, with focus on small molecule respiratory/inhalation product development. Position will primarily lead oversight of multiple programs in Respiratory franchise and some conventional small molecule programs. Primary responsibilities include, but are not limited to the following: Primary Responsibilities Provide regulatory leadership, oversight, and strategy to a team of Regulatory CMC Professionals in developing global Regulatory CMC strategy and executing submissions related to small molecule, development products. This includes preparation of applicable IND/CTA's, Agency Background Packages,...

Merck Job Description GRACS (Global Regulatory Affairs & Clinical Safety) CMC - Associate Principal Scientist, CMC - Pharm Pre-approval (Respiratory/Inhalation Products) This Associate Principal Scientist in Pre-approval Pharmaceutical CMC will be responsible for developing and implementing CMC regulatory strategies for our Company's pharmaceutical pipeline products in accordance with global regulations and guidance's, with a focus on small molecule respiratory/inhalation product development. Position will support respiratory/inhalation and some conventional small molecule programs and isresponsible for the preparation and submission of CMC dossiers. Primary responsibilities include, but are not limited to: Regulatory CMC responsibilities: Serve as a CMC Product Lead for assigned products and be accountable for the delivery of all regulatory milestones through product & device development requirements and strategies including assessment of the probability of...

Merck Job Description SENIOR SPECIALIST (P-3),Audit and Assurance Services Our company's Audit and Assurance Services primary purpose is to provide value-added independent and risk-based audit and assurance services. Position Overview / Function and Responsibility Under the direction of the Client Audit Director ("CAD") and the Auditor-in-Charge ("AIC"), the Senior Specialist will: Participate in the execution of financial, operational, SOX 404 and IT audits, integrated and process audits, both domestic and abroad to ensure a strong internal control environment is maintained at our company. On occasion, will be expected to lead small teams of auditors. Under the direction of the AIC, partner with colleagues and clients and other organizations to effectively complete all assigned audit work. Execute audit programs and work papers (including walkthroughs and sample testing) in line with the established quality standards and timelines. Present audit...

Merck Job Description The Sterile Product Development (SPD) group is responsible for developing non-oral dosage forms (injections, implants, inhaled, ocular) for small, intermediate, and large molecules from preclinical toxicology studies to commercialization. Our development teams ensure robust composition, primary packaging/device, and process selection through deep fundamental understanding and characterization such that the process is scalable without compromising stability, safety, efficacy, and delivery. During development, we leverage smart experimental design, cutting edge analytical tools, and predictive approaches to inform molecule, formulation and process selection. In summary, our team enables the translation of preclinical candidates into non-oral drug products. Our team is looking for a strong candidate for the position of Principal Scientist (R5) within the Biologics product development group. Primary duties: Be a seasoned biologics product developer...

Merck Job Description As the Director, Primary Market Research for Oncology, you will join a team of passionate, data-driven strategists who partner with stakeholders at local, regional and global levels to enable value-driven decision making. You will lead and coach a team of market research professionals (both US based and indirect team members based in India) responsible for planning, prioritizing, managing and executing work across the therapeutic area spanning pre- and post-launch, as well as future assets. You will manage a diverse set of stakeholders at all levels and collaborate closely with peers in the Primary Market Leadership team and across the Digital Human Health (DHH) organization. Your Market Research and Analytics expertise will position you as a strategic partner who proactively engages cross-functional brand teams to address key business questions. You will be an exceptional leader and active member of the Primary Market Research leadership team. You...

Merck Job Description The Director, Quality Assurance will be responsible for team leadership and technical subject matter expertise in Sterile Drug Product Quality Operations at our Company's Rahway, New Jersey site. This position will serve a critical role in supporting the expansion of clinical development activities at the site with responsibilities including, but limited to the following: Execute GMP quality assurance activities directly related to sterile drug product production and release for clinical trial material supply. Support the start-up of a new, state-of-the-art sterile filling line. Support the design and operational readiness of multiple other significant capital projects that are aligned with the expanding site mission. Develop relationships with and provide Quality oversight of key partner groups that are commensurately expanding in size and scope of work. Lead and develop a growing team of professionals. The successful candidate...