Head of North American Region, Global Regulatory Affairs @ IQVIA
Director, Global Regulatory Affairs @ IQVIA RDS
Associate Director, Global Regulatory Affairs @ Quintiles
MS, Natural Sciences @
State University of New York at Buffalo
Marian has 17 years regulatory affairs and medical writing experience in the pharmaceutical industry where she participated as regulatory project manager, lead medical writer, or played a major role in the development of scientific documents and regulatory submissions: Investigational New Drug [IND] Applications, New Drug Applications/Biologic License Applications [NDA/BLA] in CTD format, Clinical Study Reports, Protocols, Investigator
Marian has 17 years regulatory affairs and medical writing experience in the pharmaceutical industry where she participated as regulatory project manager, lead medical writer, or played a major role in the development of scientific documents and regulatory submissions: Investigational New Drug [IND] Applications, New Drug Applications/Biologic License Applications [NDA/BLA] in CTD format, Clinical Study Reports, Protocols, Investigator Brochures, briefing documents for FDA or other regulatory authority meetings, clinical development plans, safety update reports, patient narratives, clinical trial registry summaries, manuscripts, and meeting abstracts for marketing groups. She received her Bachelors in Biology from Mercyhurst University, an MS in Natural Sciences and then PhD in Pharmacology from the State University of New York at Buffalo (Roswell Park Cancer Institute Graduate Program). Marian continued her training as a postdoctoral associate at University of North Carolina Lineberger Cancer Center. Marian subsequently joined Lineberry Research Associates/SRA International and worked there for 10 years prior to consulting as a MW or project manager on regulatory and medical writing projects. She recently joined Quintiles in 2014 and is Associate Director of Global Regulatory Affairs, based in RTP headquarters. She has contributed to projects in academia and industry in the following therapeutic areas: oncology, gastrointestinal, neurology, psychiatry, respiratory, cardiovascular, rheumatology, metabolic disease, infectious disease, and pediatric studies where she has demonstrated the ability to work across departmental functions to achieve project goals.
Associate Director, Global Regulatory Affairs @ •Direct, oversee and manage complex regulatory projects, ensuring quality deliverables on time and within budget. Ensure that all project work is completed in accordance with SOPs, policies and practices.
•Project Manager for large stand-alone programs, involving several regulatory or technical deliverables and/or region, and/or operation. Undertakes risk analysis, management and contingency plans, as appropriate.
•Provides strategic regulatory and/or technical consultancy on a variety of projects, internally and externally, using innovative solutions where appropriate.
•Manages meetings with Regulatory Agencies.
•Writes and/or reviews a complete single service regulatory proposal and defends costs and timelines to clients.
•Provides mentorship to junior colleagues and advise others on many regulatory document types.
•May plan and deliver workshops or presentations on Regulatory Affairs topics for conferences or publications.
•May be assigned as Reviewer and/or Approver for Regulatory SOPs or cross-functional SOPs owned by other operations. From June 2015 to Present (5 months) Research Triangle Park, NCAssociate Director, Global Medical Writing and Document Publishing @ Manage and support the direction of a team of Medical Writing (MW) staff to efficiently produce documents that meet customer requirements. Participate in project teams as writing lead and project manager for MW projects. Provide senior review and guidance for most documents prepared by junior staff. Review and monitor budget for projects and those of direct reports and/or departmental budgets, including out of scope activities, and ensures that revenue is recognized as appropriate. From May 2014 to Present (1 year 6 months) Research Triangle Park, NCSenior Medical Writer and Regulatory Consultant @ Document/dossier preparation and regulatory affairs (project management, medical writing, regulatory liaison). Drug development strategy (submission strategy, CDPs, feasibility, KOL advisory panels, strategy for SAPs). From October 2008 to May 2014 (5 years 8 months) Chapel Hill, NCAssociate Director, Regulatory Affairs and Strategic Drug Development Services @ Line management of regulatory affairs personnel; Regulatory document/dossier preparation/regulatory affairs; Drug development strategy From January 2007 to September 2008 (1 year 9 months) Research Triangle Park, NCAssistant Director, Clinical Operations and Regulatory Affairs @ Line management of regulatory affairs and clinical operations personnel. Regulatory document/dossier preparation/regulatory affairs. Drug development strategy. Clinical trial management and monitoring. From 1998 to 2006 (8 years) Research Triangle Park, NC
MS, Natural Sciences, PhD, Cancer Pharmacology @ State University of New York at Buffalo From 1986 to 1994 BS, Biology, Chemistry minor @ Mercyhurst University From 1982 to 1986 Marian Rhodes is skilled in: Regulatory Affairs, Medical Writing, Drug Development, Clinical Operations, Medicine, Strategy, Clinical Development, Pharmaceutical Industry, Regulatory Submissions, Clinical Trials, CRO, GCP, Oncology
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