Kim (Cilmi) Rolland Email and Phone Number

Senior Medical Writer for a global CRO. Responsibilities include preparation of clinical protocols, integrated clinical and statistical reports, informed consent and assent forms, and other clinical documents in compliance with ICH guidelines, applicable SOPs, and guidelines specified by the FDA and international regulatory agencies. Collaborate with international CRO and sponsor teams during document preparation.Additional responsibilities include reviewing study-generated tables, listings, and figures, reviewing statistical analysis plans, representing medical writing in project team meetings, facilitating and participating in CRO and sponsor review processes of all documents, assisting in appendices compilations, and performing quality control of documents.

Contract medical writer supporting major global CRO in their Phase 1 department. Responsibilities included preparation of clinical protocols and integrated clinical and statistical reports in compliance with ICH guidelines, applicable SOPs, and guidelines specified by the FDA and international regulatory agencies. Collaborated with CRO and sponsor experts on appropriate methodologies and clinical activity related to document preparation. Clinical study report preparation involved reviewing study-generated tables, listings, and figures, assisting in interpreting clinical safety and pharmacokinetic data, assisting in articulating statistical and pharmacokinetic results and conclusions, and interacting with CRO experts and sponsors to determine format, design, and presentation of results.Also reviewed statistical analysis plans to ensure clarity and accuracy, represented medical writing in project team meetings, facilitated collaboration between the CRO and the sponsor, facilitated and participated in CRO and sponsor review processes of all documents, assisted and oversaw completion of appendices compilations and electronic publishing, interfaced with multiple CRO teams to facilitate medical writing timelines, editing, and electronic publishing.

Provided medical writing of clinical regulatory documents and filings for pharmaceutical and CRO clientele.

Medical writer for a company specializing in post-marketing pharmacovigilance and pharmacoepidemiologic research and consulting for the pharmaceutical industry.

Provided medical writing of clinical regulatory documents and filings for pharmaceutical companies and CROs throughout the country. In addition to document preparation, collaborated with staff from data management, clinical research, biostatistics, project and program management, and regulatory affairs in the resolution of data-related issues, review of analysis plans, preparation of table and listing templates, project coordination, and quality assurance of documents.

Medical Writer for major pharmaceutical company. Wrote, edited, and reviewed clinical regulatory documents. Other responsibilities included preparation of analysis plans and preliminary data displays for clinical study reports and integrated summaries, conducted status meetings to track project progress, and contracted and coordinated activities of contract medical writers. Performed role of lead writer for an NDA.

Medical Writer for major pharmaceutical company. Wrote, edited, and reviewed clinical regulatory documents.

Prepared clinical trial protocols of antiretrovirals to treat HIV. Collaborated with principal investigators, biostatisticians, data managers, FDA and NIH representatives, and pharmaceutical sponsors. Facilitated team meetings, maintained database of protocol-related activities and status, coordinated activities for Pediatric, Neurology, and Pharmacology Committees of AIDS Clinical Trial Group (ACTG).

Clinical Trial Associate for small CRO. Responsibilities included clinical trial monitoring, protocol preparation, data management, and regulatory writing.

Prepared CSRs, patient narratives, adverse event line summaries for antidepressant/anxiolytic NDA in CNS division of Medical Writing department.

Preclinical scientist for drug development in CNS subdivision of Neurochemisty department.