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Job: Regulatory Clinical Affairs Scientist, RTI International, Research Triangle Park, NC
Regulatory Clinical Affairs Scientist
Research Triangle Park, NC 27709 United States
RTI International is currently seeking a Regulatory Affairs Scientist with a background and interest in clinical affairs as it relates to drug development. The successful candidate will support project activities related to the development of new drugs to treat neglected diseases and for other unmet medical needs. The primary responsibility of this position will be to provide regulatory guidance, supplemental writing, and review of clinical reports and pertinent regulatory submission sections for multiple concurrent drug, and biologics development projects. This individual will fulfill a key role with a focus on clinical affairs as a member of a team of scientists in RTI’s Global Health Technologies Group working to develop new products to address critical unmet global health needs and opportunities.
- Write and support the preparation of clinical and regulatory documents required to support client’s global drug development and registration activities.
- Serve as the primary medical writing representative on assigned product teams and closely collaborate with personnel from clinical, regulatory and scientific departments.
- Manage the writing, editing and reviewing of diverse regulatory and clinical document including protocols, informed consents, clinical data summaries clinical study reports (CSRs), and other medical/regulatory documents including regulatory summary documents.
- Manage the quality, accuracy and compliance to internal and external standards and the timely production of English language documents.
- Plan and oversee regulatory activities for drugs and biologics for clients.
- Provide regulatory assistance or serve as regulatory contact for FDA or other regulatory agency submissions
- Manage the regulatory submission process and regulatory agency interactions.
- Plan, schedule and direct activities and programs through regulatory staff.
- Working with a project coordinator, ensure maintenance of each development program’s applications, documentation, per regulations.
- Ensure CRO and consultant deliverables and activities are prepared or conducted on time and of high quality. Review study reports and related documents for compliance with regulatory requirements and good scientific principles.
- Prepare planning, strategy, summary documents, etc. for use in communicating with Sponsors.
- Provide expertise and strategy, to multi-functional project teams as the regulatory leader.
- Ensures compliance with GCP, GMP, and regulatory guidelines.
- Initiative and independence to identify short and long-term project needs, formulate plans for satisfying those needs, and identifying resources to implement project plans.
- Conduct internal (i.e., within RTI) and external business-development activities to raise profile of Global Health Technologies’ drug development capabilities. These activities will include the preparation of proposals for submission to funding agencies.
- MS degree in biology, chemistry, nursing or related field with 12 or more years of experience; or PhD with 8 or more years of experience in drug development activities to include a focus on clinical affairs. RAC certification a plus. Experience with FDA drug and biologics development and experience interacting productively with regulatory authorities.
- Experience with clinical trials, maintaining essential documents, reviewing/writing protocols and clinical study reports.
- Excellent oral and written communications skills.
- Ability to lead and work as a member of multiple project teams, and negotiate and achieve consensus in diverse groups.
- Ability to prioritize and multi-task concurrent project demands.
- To qualify, applicants must be authorized to work in the United States.
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