11 jobs found in Rahway, NJ

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 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 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 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 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 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 Role Summary: The Global Associate Director Medical Affairs (GADMA) has scientific and working knowledge in their area of responsibility (eg, defined tumor, asset, vaccine) and responsible for supporting execution of the Global Medical and Scientific Affairs (GMSA) portion for their assigned Therapeutic Areas (TA) or across areas as needed, in alignment of the Global Value & Implementation (V&I) Plans. They support the global cross-functional teams, engage with their network of scientific leaders and bring executional excellence and business savviness to the organization. They have a focus on the US, while also supporting the Rest of the World (ROW). The GADMA works as part of a high-performing and results driven team. Responsibilities and Primary Activities: Supports execution of the annual V&I plan with medical affairs colleagues and acts as an empowered partner, making informed decisions with a strategic and agile mindset....

Merck Job Description Role Summary: The Global Associate Director Medical Affairs (GADMA) has scientific and working knowledge in their area of responsibility (eg, defined tumor, asset, vaccine) and responsible for supporting execution of the Global Medical and Scientific Affairs (GMSA) portion for their assigned Therapeutic Areas (TA) or across areas as needed, in alignment of the Global Value & Implementation (V&I) Plans. They support the global cross-functional teams, engage with their network of scientific leaders and bring executional excellence and business savviness to the organization. They have a focus on the US, while also supporting the Rest of the World (ROW). The GADMA works as part of a high-performing and results driven team. Responsibilities and Primary Activities: Supports execution of the annual V&I plan with medical affairs colleagues and acts as an empowered partner, making informed decisions with a strategic and agile mindset....