Responsible for providing regulatory strategic, scientific, technical, and operational expertise by leading project teams to support external and internal clients in the preparation the preparation, summary, interpretation, review, and finalization in all phases of regulatory development and scientific writing projects in accordance with any applicable CTI Standard Operating Procedures (SOPs) and all applicable regulatory guidelines. This is a subject matter expert role with no direct supervisory responsibilities.
Lead assigned project teams in a broad spectrum of Regulatory, Scientific Affairs, and Medical Writing projects to ensure key messages are clear and consistent within and across documents; provide guidance and editorial review of documents as needed to meet client specifications and regulatory requirements.
Lead formal and informal communications with regulatory agencies and committees including US Food and Drug Administration (FDA) and National Institutes of Health Recombinant DNA Advisory Committee (NIH RAC). May also include communications with the European Medicines Agency (EMA), Health Canada, and others.
Establish and maintain effective relationships with regulatory agencies and committees with a focus on FDA. Create and maintain records of regulatory interactions for project documentation. Attend interactions in-person or remotely as applicable.
Lead drug, biologic, and device development projects including strategic development plans, Pre-IND, IND, NDA/BLA, scientific advice, and other regulatory documents or projects
Provide oversight and guidance of standard and accelerated regulatory designations and filings such as Orphan, Breakthrough, Fast-Track, PRIME, and other designations as they occur within various regulatory agencies
Lead the conduct of scientific research to assimilate data into written deliverable products for clients such as protocols, clinical study reports, briefing documents, abstracts, white papers, and clinical expert reports and other documents intended for submission to regulatory authorities, training materials, and written summaries
Collaborate with departmental and organizational leadership to develop, implement, and maintain a departmental regulatory platform, training development, and standard operating procedures.
Serve as a subject matter expert for business development capabilities presentations, client visits, and programs as needed; actively seek-out additional business opportunities in conjunction with the business development and management teams
Maintain ongoing knowledge of updated US and global regulatory requirements, guidance documents, and best practices.
Develop and maintain knowledge and expertise across multiple therapeutic areas through ongoing awareness of industry practices, clinical guidelines, and participation in professional activities
Support the advancement of corporate and/or departmental initiatives
Mentor and provide guidance to departmental staff
Perform a variety of complicated tasks. A high degree of creativity and flexibility is expected
• Demonstrated excellent scientific research skills with attention to detail and ability to integrate scientific medical information with superior written communication skill • Experience with development of complex technical documents including regulatory planning strategies, pediatric research plans, Pre-IND/Pre-Submission meeting requests, IND, NDA, BLA, and others as applicable. • Strong working knowledge of accelerated approval pathways related to orphan and rare disease across global regulatory agencies • In depth knowledge of global electronic submission requirements for regulatory documents such as eCTD publishing • Demonstrated ability to effectively lead project teams responsible for assimilating complex medical/health-related information • Must be capable of effectively handling multiple projects simultaneously with ability to prioritize tasks to meet client or departmental needs • Ability to work in an autonomous manner and be self-motivated • Proven track record of excellent effective communication (both verbally and in writing) • Must have strong interpersonal skills and the ability to build relationships and influence others while working towards common goals • Must demonstrate a professional demeanor and sensitivity to confidential information
Masters of Science, Masters of Public Health, or Masters degree in fields such allied health, nursing, pharmacy or natural sciences
At least 15 years of direct experience working in the pharmaceutical industry (e.g., contract research organization or pharmaceutical company) or related area or at least 12 years of experience with an advanced degree in a related area (PharmD, DrPH/PhD, Nurse Practitioner)
Proven expertise as a Clinical or Regulatory lead managing drug and/or device development projects pre- and post-marketing
Experience in preparation of technically complex documents intended for submission to regulatory authorities (e.g., briefing documents, clinical study reports)
Expert knowledge of the drug and/or device development process and associated regulatory requirements
Expert knowledge of ICH Good Clinical Practice guidelines and applicable regulatory requirements
Advanced technical skills in Microsoft Office including Word, PowerPoint, Excel, and ability to quickly learn and adapt to new systems and technologies
Understanding of basic business-related financial and business development concepts
At least 10 years of experience with orphan and rare disease designations, hematology/oncology, immunology, gene or cell therapy and other complex medical disease states
Demonstrated history of direct interaction with regulatory agencies (e.g, FDA, EMA, Health Canada)
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About CTI Clinical Trial and Consulting
CTI was founded in 1999 to provide therapeutic expertise to the pharmaceutical and biotechnology industry across a range of services. We have experienced consistent and significant growth from a US-based organization to a multi-national corporation with associates in more than 25 countries across the world. We have worked on more than 2,700 projects on six continents during the company lifetime, and have contributed to more than 100 new drug and device approvals through global regulatory agencies such as the FDA, EMA, and others. Visit www.ctifacts.com for more information.
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