SONUS Pharmaceuticals, Inc.

Document Control and Regulatory Affairs Specialist II

REPORTS TO: VP, Regulatory Affairs & Quality Assurance

REVISION DATE: January 2006

Primary responsibilities include: 1) tracking, archival and retrieval of all GxP documentation; and 2) documentation and logistics support of activities related to preparation of regulatory dossiers to be submitted to health authorities. Ensures in-house archived documentation is appropriately controlled, and that such documentation is readily, reliably and accurately retrievable for regulatory submissions and/or inspections by regulatory authorities, and for authorized internal users. Tracks and helps to facilitate required GxP training for Sonus staff.

MAJOR DUTIES and RESPONSIBILITIES:

Document Control:

• Demonstrates an intimate understanding of paper and electronic document control systems, and a very high level of organization.
• Maintains and upgrades the documentation archival and retrieval system for GxP documents, including both paper and electronic systems.
• Proactively collaborates with internal line function staff and multidisciplinary project team members to generate GxP documents within appropriate architecture for document archival.
• Primary responsibility for logistical management of controlled documents (e.g., assigning control numbers to new documents, maintaining version control, document obsolescence, maintaining up-to-date binders of printed SOPs and/or web-based availability of SOPs in order to ensure immediate access of all staff to current versions of controlled documents).
• Writes, revises and reviews documents in support of document control (e.g., SOPs, best practices guidelines, work instructions and specifications).
• Tracks individual staff GxP training requirements and completion of training; maintains individual staff training files. When needed, works cooperatively with line function staff to facilitate training and documentation.

Regulatory Affairs:

• Demonstrates an impeccable level of organization and attention to detail.
• With direction, assists in preparation and maintenance of Investigational New Drug Exemption (IND) files to U.S. FDA and similar documents (e.g., Clinical Trial Applications/CTAs) to other national health authorities, including retrieval of appropriate component documents from a variety of sources, and management of the logistics of the preparation and submission process for new INDs/CTAs and subsequent IND/CTA Amendments and supporting documents.
• With direction, assists in preparation and submission of regulatory reports to health authorities (e.g., IND Annual Report, IMPD updates, Investigator Brochure).
• With direction, takes primary responsibility for preparing selected routine regulatory submissions to health authorities (e.g., submissions related to clinical protocol amendments or identification of new clinical investigators).
• With direction, assists in the preparation of New Drug Applications (NDAs) to FDA and similar documents (Marketing Authorization Applications, MAAs) to other national health authorities, including retrieval of appropriate component documents from a variety of sources, and management of the logistics of the preparation and submission process. Ensures compliance with appropriate standards for document format and content.

LEVEL REQUIREMENTS:

This is an intermediate position involving routine work, but where a degree of initiative is expected. Typically requires a BA/BS degree in a scientific discipline or related field with 2-5 years experience; or a MA/MS degree in a scientific discipline or related field with <2 years experience. Must be proficient in using Microsoft Office® applications.

The Document Control component of this position requires experience with, and intimate understanding of, paper and electronic document control systems and a high level of organization. Small pharmaceutical/biotechnology company experience in managing document control without the infrastructure of a sophisticated electronic document control system is highly desirable.

The Regulatory Affairs component of this position requires a high level of organization and attention to detail. While experience preparing dossiers for submission to regulatory authorities is highly desirable, previous experience is not a requirement.

TO APPLY:

Please e-mail your resume to careers@sonuspharma.com.

SONUS Pharmaceuticals, Inc.

Email: careers@sonuspharma.com

SONUS Pharmaceuticals, Inc. is an Equal Opportunity Employer

Submitted: 03/13/2006