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The Manager, Medical Information will assist in the operational oversight of medical information within the Medical Affairs function under the guidance of the Lead of Medical Information. The manager will be responsible for providing and supporting the provision of accurate, scientifically balanced and timely responses to inquiries received from health care professionals, consumers and other customers. The manager will monitor the scientific literature and communicate new data to relevant....


The Rare Disease Global Regulatory Team Lead (GRTL) is a Director-level role which is part of the Global Regulatory Affairs (GRA) team based in the US. He/she is responsible for developing long- and short-term regulatory strategies that impact company’s business objectives. Specific responsibilities include: Global Regulatory Team Lead (GRTL) is responsible for developing global regulatory strategy for projects in his/her remit, which include both pipeline and life cycle management programs.....

- Buffalo, NY

Clinical Project Manager As a Clinical Project Manager (CPM), you will work in a matrix management environment and serve as the primary contact for interdepartmental and external study contacts. This experienced CPM role is responsible for managing all stages of a clinical study within GCP and ICH guidelines when direct management by the sponsor is required. The CPM may also function as the liaison and provide support for sponsor managed studies in an international setting, and, may oversee....


Clinical Research Associate POSITION OBJECTIVE: Work within a clinical team setting to ensure compliance with protocol and overall clinical objectives. Essential Job Functions/ResponsibilitiesParticipates in the preparation and/or review of draft protocol and informed consent documentsPossesses detailed knowledge of the study protocol and its associated activities and timelinesParticipates in conference calls, prepares agenda and summariesCoordinates with project team and other study personnel


Clinical Research Associate POSITION OBJECTIVE: Work within a clinical team setting to ensure compliance with protocol and overall clinical objectives. Essential Job Functions/ResponsibilitiesParticipates in the preparation and/or review of draft protocol and informed consent documentsPossesses detailed knowledge of the study protocol and its associated activities and timelinesParticipates in conference calls, prepares agenda and summariesCoordinates with project team and other study personnel


Safety Physician POSITION OBJECTIVE: Supports the Pharmacovigilance team in reviewing, querying, documenting and reporting on all serious adverse events (SAE) & Suspected Unexpected Serious Adverse Reactions (SUSAR) cases related to clinical studies. Essential Job Functions/ResponsibilitiesProvide timely and sound medical review of individual case safety reports (ICSR) from clinical trials.Actively participates in the case initiation process (case triage) and case data inputting/data entry

- Cranford, NJ

As a Clinical Study Monitor, you will work within a clinical team setting to ensure study compliance with protocol, FDA and ICH guidelines. Essential Job Functions/Responsibilities · Ensure the Sponsor, Investigator, and study team adhere to current FDA regulations, applicable ICH/GCP guidelines, local policies and standard operating procedures. · Adhere to monitoring plan protocols; e.g. monitoring visit type, frequency, and required critical monitoring activities by utilizing monitoring....

- Buffalo, NY

Senior Clinical Research Associate POSITION OBJECTIVE: Work within a clinical team setting to ensure compliance with protocol and overall clinical objectives. Essential Job Functions/ResponsibilitiesParticipates in the preparation and/or review of draft protocol and informed consent documentsPossesses detailed knowledge of the study protocol and its associated activities and timelinesParticipates in conference calls, prepares agenda and summariesCoordinates with project team and other study....

- Cranford, NJ

Senior Clinical Research Associate POSITION OBJECTIVE: Work within a clinical team setting to ensure compliance with protocol and overall clinical objectives. . Essential Job Functions/ResponsibilitiesParticipates in the preparation and/or review of draft protocol and informed consent documentsPossesses detailed knowledge of the study protocol and its associated activities and timelinesParticipates in conference calls, prepares agenda and summariesCoordinates with project team and other study....

- Cranford NJ & Buffalo NY, NJ

POSITION OBJECTIVE: Provide Statistical Programming Support for Clinical Data Analysis and Submission. Essential Job Functions/Responsibilities This role is expected to contribute to the quality of data analysis and reporting deliverables for phase I to III clinical trials. Provide programming support for the clinical study team by generating and maintaining patient profiles, tables, listings, figures and other types of outputsCreate annotated CRFs, mapping specifications and datasets per SDTM

- Cranford NJ & Buffalo NY, NJ

POSITION OBJECTIVE: Provide Statistical Programming Support for Clinical Data Analysis and Submission. Essential Job Functions/Responsibilities This role is expected to contribute to the quality of data analysis and reporting deliverables for phase I to III clinical trials. Provide programming support for the clinical study team by generating and maintaining patient profiles, tables, listings, figures and other types of outputsCreate annotated CRFs, mapping specifications and datasets per SDTM


Top Tier Pharmaceutical company (with focus in Cardio, Respiratory, CNS, Psych and more) in Madison, NJ is looking for a new Director, Clinical Development for to add to this growing team!The Director Clinical Development will report directly to the Vice President and is responsible for the scientific, strategic, therapeutic, and operational management of programs to evaluate, register, and market pharmaceutical agents. Lead and direct study programs, activities, and teams for one or more....

- Any US State

Position Summary: The Senior Director, CMC Regulatory Affairs will be responsible for providing CMC regulatory leadership and strategy across the organization and to our global partners. The Sr Director, CMC Regulatory Affairs will collaborate with the clinical development team, including the Chief Scientific Officer and drug substance and drug product manufacturers, and others for drug development and manufacturing in the pharmaceutical and biotech industry in accordance with the protocol,....

- Any US State

The Senior Director, CMC Regulatory Affairs will be responsible for providing CMC regulatory leadership and strategy across the organization and to our global partners. The Sr Director, CMC Regulatory Affairs will collaborate with the clinical development team, including the Chief Scientific Officer and drug substance and drug product manufacturers, and others for drug development and manufacturing in the pharmaceutical and biotech industry in accordance with the protocol, standard operating....


Position Overview Plans, directs, and executes product formulation and process development activities in support of development of new products intended for clinical trials and commercialization with focus solid and liquid dosage forms including immediate and controlled/modified release systems. Conducts research in the area of formulation sciences in support of innovative product development both for new chemical entities and life-cycle management of marketed products. Experience in the....

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