Statistical Programmer II (6m)
Smith Hanley - New Jersey
Statistical Programmer II (6m)-Provide statistical programming support and validation and help set specifications of analysis datasets, pooled datasets, statistical tables, summaries, figures and listing for Phase II-IV clinical trials. Employ standardized programs where applicab...
Smith Hanley - Florida
Smith Hanley Consulting Group LLC seeks Clinical Statistician in Houston, TX. Provide statistical expertise for study case report for design, data base structure, analysis plan, and review of the study protocols and reports. Perform data analysis and provide statistical support i...
Smith Hanley - New York
Safety Surveillance Assoc 12m-Provides support for the review of potential adverse events of Pfizer products. Reviews and assesses domestic/international clinical trials and post-marketing surveillance AE reports on marketed products. Determines regulatory reporting requirements ...
Smith Hanley - Connecticut
Medical Sourcing Mngr (6m)-1. Works with the category lead and relevant medical business partners globally to establish and implement category strategy. 2. Identifies, formulates and implements strategic contracts for assigned projects within Medicine & Drug Regulatory Affairs, a...
Smith Hanley - New Jersey
Job Role: • Provide project management support Sales Training by managing business process activities, assisting project teams. • Organizational effectiveness activities that support training priorities: • Communicate process changes to stakeholders. • Identify process improvemen...
Smith Hanley - North Carolina
QC Associate (12m)-Performs chemical, in-vitro, or in-vivo biological assays of clinical and/or commercial product raw materials, production intermediate and bulk samples, finished product, environmental monitoring samples, process & cleaning validation samples, package samples a...
Smith Hanley - San Francisco, CA
Drug Safety Scientist needed for a 6 month position with potential for renewal in S. San Francisco. Drug Safety Scientist (DSS) is responsible for implementing and coordinating safety surveillance procedures for delegated products. Responsibilities of the DSS include monitoring t...
Smith Hanley - California
A Clinical Trial Assoicate I is needed for an 18-month contract position at major biotech in Northern California. contract Clinical Trial Associate (cCTA) reports to Clinical Program Leader Purpose: The contract Clinical Trial Associate (cCTA) is responsible for providing logisti...
Smith Hanley - Massachusetts
Clinical Trial Head (6m)-Accountable for all aspects of assigned OTM clinical trials (Phase I/II) including leading Clinical Trial Team(s) (CTT). Number of clinical trials depends on the workload and complexity of the individual trials. Responsible for program level activities as...
Smith Hanley - New Jersey
This position supports North America Scientific & Clinical Purchasing with contract coordinating for new contracts and change orders including contract planning, preparation, & review and follow-up for services pertaining to clinical studies Phase I through Phase IV The position ...
Smith Hanley - Ohio
Technical Writer (3m)-Technical Writing role writes, or supports the development of, various technical documents such as: requirements, specifications, test plans, and user manuals. Provides evidence of compliance with legal, business and regulatory requirements; • Translates hig...
Sr. Reg Compliance Auditor 12m
Smith Hanley - California
Sr. Reg Compliance Auditor 12m-Audits areas of the company Vascular quality system, such as development and manufacturing, as assigned.; Creates audit checklists based on assigned area, applicable regulations, and pertinent company Vascular quality system/procedural requirements,...
Assoc Clinical Data Mgmt Syste
Smith Hanley - California
An Associate Clinical Data Management Systems is needed for an 18-month contract position at major biotech in southern California. Job Description: Individual will partner with individuals within Clinical Data Management to provide operational support. Duties include entry of dat...
Smith Hanley - California
A Global Safety Scientist is needed for a 7-month contract position at major biotech in Southern California. Role Purpose: To provide medical and safety input into the clinical scope, review criteria, analysis and interpretation of safety data. To develop and execute the safety s...
Smith Hanley - San Francisco, CA
Regulatory Assistant Needed for a six month position in S. San Francisco. Job Description: QA final labeling and promotional materials and create high-quality, accurate submissions to FDA Supports Promotional Review Committee (PRC) Chairs and PRC team members by reviewing and ens...
Smith Hanley - New Jersey
Safety Assistant (12m)-Execution of local activities relevant to the management of safety data Primary Responsibilities: - Maintain local documentation as required by legislation (including archiving/tracking/retrieval) - Support the submission and distribution of reports and rel...
Smith Hanley - Pennsylvania
The Statistical Programmer is responsible for providing significant programming support to the statisticians as part of the contribution towards the completion of statistical analyses (tables, listings and figures) and reporting of results of clinical studies. It includes Safety,...
Smith Hanley - Massachusetts
QC Analyst (12m)-Performs a variety of qualitative and quantitative analytical assays to support raw material, in-process, intermediate and final product testing according to standard operating procedures and regulatory requirements. Performs laboratory operations necessary to su...
Smith Hanley - New York
Epidemiology Lead (6m)-Provide and carry out various Epidemiology group deliverables. These may include: o Consult on / authoring of regulatory responses and participation in regulatory meetings related to safety or risk assessment o Safety epidemiology literature reviews support...
Smith Hanley - California
Quality Compliance Spec (12m)-Perform Regulatory Compliance Audits as needed: Self Inspections, Supplier, and Third Party Audits Manage audit lifecycle (audit report, CAPA follow up) using Sentry Trackwise database. Follow up on CAPA actions to completion. Track status of audits ...