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Job #03062

About our client Our client is a leading provider of contracted drug development services to the pharmaceutical industry. Their services span from pre-clinical through manufacturing, clinical, regulatory and commercial phases of drug development. Our client’s executive team are accomplished leaders in the full spectrum of drug development and have extensive experience working in and with pharmaceutical, biotech and contract services organizations. Position Location Director and Subject Matter Expert Cincinnati, Ohio Salary Highly competitive package, commensurate with experience Responsibilities 1) Guide research scientists to appropriate literature searches and FDA regulations/guidelines 2) Monitor the research and writing of 505(b)(1)& 505(b)(2) clinical safety and efficacy summaries, generic/bioequivalence clinical summaries, all reports for full regulatory submissions 3) Oversee custom reports (research reports, pre-IND packages, and responses to FDA requests) for client organizations 4) Ensure documents are written in compliance with all regulations (ICH, GLPs, GCPs) and the sponsor’s requests 5) Interact with the FDA 6) Lead pre-IND, EOP2 or NDA meetings and/or act as the project lead in the review and writing of INDs, NDAs or ANDAs 7) Oversee the preparation of clinical development study synopses and white papers/position pieces based upon literature/information searches 8) Ensure documents are complete and accurately reflect the information provided in the public domain (scientific articles, summary basis of approval, Freedom of Information requests, etc.) 9) Review, edit and assist scientists in document preparation (as needed) 10) Provide assistance in researching relevant background material (non-clinical, clinical pharmacology, safety and efficacy) 11) Provide guidance on integrating scientific information to provide strategic recommendations on product development programs 12) Coordinate ongoing training and development of Research Services Team 13) Provide strategy in determining the Reference-Listed Drug (RLD) for 505(b)(2) projects 14) Ensure that staff is adequately educated in the creation of documents and that documents comply with protocols, SOPs, GLPs, GCPs and sponsor requests 15) Perform other related business duties as assigned by the immediate supervisor and other management (as required) Requirements 1) Master’s degree in a scientific or Life Science related field 2) Minimum 3 years of experience as a primary author, writing regulated scientific documents 3) Knowledge of and experience in a combination of regulatory and scientific writing 4) Expertise in writing all documents such as feasibility reports, briefing packages, clinical study reports/synopses/protocols, etc. 5) Excellent interpersonal skills 6) Superb analytical skills 7) Proficient in using MS Office (Word, Excel, PowerPoint and Access) 8) Ability to manage multiple and diverse projects concurrently 9) Team player with high integrity and an open, interactive style 10) Self-directed with considerable initiative 11) Ability to develop relationships and generate collaborations 12) Ability to think strategically as well as plan and implement 13) Flexible attitude regarding schedule and work projects