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Associate Director/Director Biostatistican 1 Year Contract – NJ Description Candidate in this position will be providing support to the IMI-EPAD (Innovative Medicines Initiative – European Prevention of Alzheimer’s Dementia) consortium. This senior level contract statistician will: – Support group by  reviewing key documents, as well as be part of the Work group on statistical engine …

Sr. Publishing Specialist 1 yr Contract – NJ   Duties: The Senior Publishing Specialist will be part of the Regulatory Operations Publishing Group and to ensure that dossier is prepared ready to submit to the FDA and other agencies. This includes: Publishing(Bookmarking and Hyperlinking) and Peer Reviewing different types of document like (eg Clinical Study …

Biostatistical Programmer 1 yr Contract – NJ   Duties: To support the Biostatistics team by carrying out programming activities of statistical programmers and overseeing external vendors (as required), and to ensure timely and accurate programming and validation activities for clinical studies and publications. Contributes to the overall efficiency and best practice of the Biostatistics group, …

Clinical Study Manager 1 Year Contract – NJ   Duties: Accountable for the overall management of all assigned clinical studies, in accordance to SOPs. Study Manager must have the ability to work semi-autonomously with strong organizational, prioritization and analytical skills. Must be comfortable collaborating with other functional teams to coordinate the development and finalization of …

Communications/Public Relations Consultant 6mos – 1 yr Contract – NJ   Duties: Assist sales and marketing management with communications media and advertising materials to effectively represent the company’s products and services to customers and prospects. More specifically: 1. Experience in promotional material development including: Working with/in ad agency Reviewing materials with CRC- Copy Review Committee …

Documentation Coordinator 1 Year Contract – NJ Duties: Global Regulatory Department Perform daily document management activities such as Review, Processing, Filing of Clinical Trial Master File documents. Quality Control review of Regulatory Documents. Coordinate with eTMF vendor for TMF set-up and processing of TMF documents. Development of user manuals. Scanning and storage of Clinical Operation …

Financial Analyst 1 Year Contract – NJ Duties: • Preparation, communication and consolidation of the Annual Business Plan o Preparation of monthly, quarterly, full year and 18-month forecast in accordance with the submission timeline. o Build and maintain forecasting models for headcount, payroll, and expense accounts. o Variance explanations of actual performance against prior period, …

Manufacturing Technician Temp to Perm – Maryland Duties: To support the manufacture of Commercial Gliadel wafers, including execution of approved SOPs and batch records to produce a quality product according to GMP guidelines. Takes responsibility for manufacturing a quality product, performs equipment cleaning and maintenance per approved procedures, reviews and edits documentation, and supports protocol …

Procurement Specialist 1 Year Contract – NC Duties: Responsible for independently leading day-to-day purchasing activities within the Procurement function. Evaluates areas of opportunity to leverage material acquisitions; to include generating, sourcing and negotiating purchase orders (including cancellations, changes, etc), selecting or recommending suppliers, ensuring supplier compliance, managing requisition/purchase order system, monitoring supplier performance (such as …

Regulatory Documentation Specialist 1 Year Contract – NJ Duties: – Review and approve daily Clinical Safety Alert Reporting (SUSAR, 6MLL, DSUR, IND Safety Alerts) – Support the distribution of Safety Alert Reports to Investigators, Ethic Committees and CRO’s per US and EU/ROW country-specific requirements – Knowledge of databases (FirstDoc, eTMF, general Database Administration) – Interact/collaborate …