Location: Mahwah, NJ, USA
Closing Date: 11 Nov 16
Type: Full Time
Salary (£): Competitive
This is a full time, permanent, office based position in Mahwah, NJ Chiltern is an EEO / AA Employer and is committed to providing opportunities to minorities, women, individuals with disabilities and veterans.
Provide experienced standard and regulatory compliant insight to Clinical Development Plans (CDP), Clinical Study Protocols (CSP) and Clinical Study Reports (CSR) across the Innovative and Approved products/Branded generic portfolio globally. The candidate should be able to “think with the end of mind” to ensure the compliance in terms of data collection and presentation to support regulatory dossier submission. Responsibilities: Accountable for ensuring that submission datasets are conforming to the data standards required by regulatory agencies. Lead the collaboration between relevant functions (Clinical Operations, Clinical Science, Pharmacology, Data Management, Biostatistics, Regulatory Affairs,…) to produce compliant datasets for regulatory submission. Maintain knowledge of regulatory developments related to data standardization, follow the latest submissions requirements of the agencies Participate in standards-related process improvement meetings/workshops. Requirements: Minimum MSc level Technical competence: • CDASH, SDTM, Define.xml,…. • CDISC controlled terminology Experience of preparing, reviewing and submitting CDISC-compliant datasets to the regulatory agencies (i.e. FDA) Experience overseeing contractor/CRO activities Experience in standardization of clinical collections and submission modules Experience and knowledge in clinical data management tools is desirable Technical experience in programming tools is desirable Project management experience
Wilmington, North Carolina, USA
2520 Independence Blvd, Suite 202, Wilmington, NC 28412, USA
|Tel:||+1 910 338 4760|
|Fax:||+1 888 301 2627|
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