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Quality Control Associate
Ref No.: 18-13392
Location: Marlborough, Massachusetts
Summary:
A QC Associate is a member of cross-functional teams responsible for auditing regulatory submission documents (eg, protocol, investigator brochure, clinical study report) against source materials as well as proof reading documents for consistency and adherence to the established Sunovion style guide(s). In addition, a QC Associate will coordinate and prepare clinical trial documentation required for clinical study reports.
Essential Functions:
Perform quality control (QC) audits of regulatory submission documents, including protocols, investigator brochures, clinical study reports, and clinical sections of investigational new drug applications (IND) and new drug applications (NDA) – 50%
Perform consistency checks of regulatory submission documents for style, format, and content – 20%
Ensure regulatory submission documents are publish-ready by checking automated template functionality is used correctly – 5%
Coordinate the collection and review of clinical trial documentation required for clinical study report appendices 20%
Provide feedback for process improvements – 5%

Experience Requirements:
0-2 years of relevant scientific experience
Working knowledge of Good Clinical Practice guidelines and International Council for Harmonisation guidelines is strongly desired. Experience in the development of clinical documents to support regulatory agency submissions is also strongly desired
Strong organization skills and a high attention to detail
Strong interpersonal and teamwork skills
Excellent oral and written communication skills
Strong working knowledge of MS Word, Adobe PDF and Project
Confidential Data/Compliance:
All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential.
Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sunovion are carried out with the "best" industry practices and the highest ethical standards.
Mental/Physical Requirements:
Fast paced environment handling multiple demands. Must be able to exercise appropriate judgment as necessary.
Requires a high level of initiative and independence.
Excellent written and oral communication skills required.
Requires ability to use a personal computer for extended periods of time.