- Daiichi Sankyo, Inc. (Bernards, NJ)
- …record keeping and tracking of labeling milestones. Collaborates with Global Labeling Operations and Compliance Leads to produce high quality labeling ... serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational...on timelines or resources, may assist another Global Labeling Lead by managing labeling development or approval for either… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …sites. These business functions include but are not limited to Clinical Operations , Clinical Development, Biostatistics and Data Management, Regulatory Affairs, ... areas centered around rare diseases and immune disorders. Summary The Tech Lead manages enterprise level technical projects to ensure homogeneity within IT and… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Global Regulatory Affairs and Clinical Safety Global Process Lead is responsible for overseeing and managing Global Regulatory Affairs & ... Process Lead actively engages with leadership across the Global Regulatory Affairs and Clinical Safety organization and collaborates with internal and external… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …in associated contractual templates. Ensures Good Pharmacovigilance Practice and regulatory compliance in such arrangements. Oversees Local/Global ... and aggregate reporting for DSI products, both investigational and marketed. Maintains compliance with Global PV regulations for individual case safety and periodic… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …position mentors and may manage assigned staff, partnering with the Global Labeling Operations & Compliance group and across the cross-functional and cross- ... record keeping and tracking of labeling milestones. Collaborate with Global Labeling Operations and Compliance leads to product high quality labeling… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …team members to ensure that the organization is in a perpetual state of compliance as follows:Support the Global Quality Lead (s) (GQLs) and Regional Quality ... the status of Quality Events (QEs), CAPAs and GCP compliance matters raised to the GQLs and/or RQLs from...meetings or other relevant activities.Support the External Partner Quality Lead (s) (EPQLs), who are responsible for delivering and executing… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …position mentors and may manage assigned staff, partnering with the Global Labeling Operations & Compliance group and across the cross-functional and cross- ... record keeping and tracking of labeling milestones. Collaborate with Global Labeling Operations and Compliance leads to product high quality labeling… more
- Merck & Co. (Rahway, NJ)
- …development and maintenance of Core and US Labeling for assigned products, ensuring compliance with internal and regulatory standards.You will assist in the ... and animals. In the capacity of a Global Labeling Lead , you will be instrumental in shaping the labeling...providing advice and guidance on labeling to teams.As the regulatory labeling liaison on global Regulatory Affairs… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Oversight Management:Support monitoring oversight strategy to ensure quality and compliance across the organization with applicable policies and procedures, and ... for monitoring the following CRA central oversight activities: Determine CROs compliance with monitoring plan for on-site and remote site visits (expectations… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs. Drafts development plans, ... trial protocols. Provides medical and/or scientific direction to Clinical Operations . Represents Clinical Development on Project Teams. ResponsibilitiesStudy Strategy:… more
- Merck & Co. (Rahway, NJ)
- …Capital Process having participated on a large capital project teamExperience in regulatory compliance expectations across all phases of product development to ... integration and partnering for Pharmaceutical development/ CMC with Quality, Regulatory , Operations , Non-clinical, Clinical, and other functional areasExperience… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …More Years of post-law school experience required- 7 or More Years experience in regulatory , compliance , and legal matters relating to pricing and Market Access ... departmental expectations and goals as identified by senior management.Responsibilities- Lead drafting and negotiating contracts for commercial, Medicaid and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …and manage relationships with contractors to ensure quality of work and compliance with all company policies and regulatory guidelinesHelp improve metrics ... PLCs, VFDs and electrical practices generally attained through hands-on experience, cGMP compliance , EHS and regulatory standards (eg EPA, OSHA and… more
- Merck & Co. (Rahway, NJ)
- …to the Senior Director of GMP Operations , will oversee laboratory compliance across multiple sites, managing regulatory audits, internal quality and safety ... compliance in an analytical laboratory.Extensive experience in technical operations , including resource modeling and capacity planning.Expertise in analytical… more
- Merck & Co. (Rahway, NJ)
- …pharmacokinetics modeling software (eg, Simcyp, GastroPlus) is highly desired.Experience in regulatory compliance expectations across all phases of product ... integration and partnering for Pharmaceutical development/ CMC with Quality, Regulatory , Operations , Non-clinical, Clinical, and other functional areasExperience… more
- Merck & Co. (Rahway, NJ)
- …sites, manufacturing investigations, process validation, and authoring of regulatory submissions. -Under the general scientific and administrative direction ... next generation process development and characterization, process validation, and regulatory submission authoring. In this role, the successful candidate will… more
- Merck & Co. (Rahway, NJ)
- …development (MIDD) to routinely enable efficient drug discovery/development and/or regulatory decisions. The Pharmacometrics group within QP2 brings an experienced ... offers an opportunity for the Pharmacometrics leader to drive pipeline impact and lead a talented group of pharmacometricians.This Senior Director is expected to be… more
- Merck & Co. (Rahway, NJ)
- …data excellence and enhance the efficiency of our clinical research operations .Key Responsibilities:- Lead Data Management Initiatives:-Direct the development ... seeking a highly qualified and experienced Associate Director in Data Management to lead our data management team in supporting the pharm and vaccine veterinary… more
- Merck & Co. (Rahway, NJ)
- …internal and external to Global Clinical Supply and serves as the lead Global Clinical Supply spokesperson at clinical and development related meetings.- Working ... not limited to:--Interacts closely with key partner organizations (as a lead Global Clinical Supply Planning program representative) such as clinical development,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …to meet business objectives.Support Investigations team by providing quality and compliance input for continuous improvement; and remediation's. Lead continuous ... requirements.Strive to reduce non-conformances in supported areas by dedicatedly driving compliance .Ensure readiness of records for regulatory inspections and… more
