Marcie Roche
Senior Medical Writer and Project Coordinator, Ipsen Biopharm, Ltd.
• Medical Writing for an international company has provided me with experience in the global biotech/pharma industry and given me the opportunity to expand my experience generating and contributing to many clinical trial regulatory documents.
• As an imaging specialist for a CRO, I gained exposure to the industry and have experience with protocols, drug development and regulatory compliance.
• Consulting has strengthened my organizational skills and attention to detail as well as provided me with a proven record of producing high quality work according to strict timelines.
• As a professor, I developed educational programs and curricula and improved my ability to impart difficult scientific concepts to individuals.
• The PhD program at Dartmouth prepared me for a career as an independent scientist in biomedical research, provided me with a strong foundation in the analysis of integrated physiological systems and in the interpretation and presentation of scientific data. Through collaboration with Genzyme Corporation, I was exposed to basic clinical aspects of the biotechnology industry.
• As a laboratory manager, I prepared information for strict grant deadlines and was responsible for general laboratory maintenance and organization. Additionally, I was depended upon for my problem solving abilities and emphasis on teamwork.
• Owning a restaurant and special events coordination required enormous attention to detail in order to orchestrate meetings and high level corporate events. I developed administrative, accounting and organizational skills as well as improved my ability to communicate and correspond respectfully with clients.
5 contacts2010 - 2010• Responsible for two drug programs
• Preparation and coordination of writing activities surrounding a total of 10 Phase II, III
and IV Clinical Trial Synopses, Protocols and Errata for international company
• Updated Investigator’s Brochures (IB)
• Implemented medical writing qualification verification process and performed QC
• Supervised one Senior Medical Writer and one Publisher
• Mentored two Junior Medical Writers
• Organized and chaired video conferences and live editing sessions with upper
management
2008 - 2010• Designed and implemented quantitative and qualitative image QA protocol for an fMRI imaging clinical trial.
• Analysis, creation and preparation of images, including MRI, CT, PET, mammogram and ultrasound for clinical trials blind reads.
• Completed an in-house training program on ICH, CTD and CSR guidelines.
• Participated in meetings between CRO executives and client to develop study report content and designed templates based on client specifics.
• Prepared clinical portion of CTD for submission to regulatory agency.
• Collaborated with non-clinical writer to maintain document consistency.
2008 - 2009• Completed an in-house training program on ICH, CTD and CSR guidelines
• Participated in meetings between CRO executives and client to develop study report content
• Designed template for study report based on client specifics
• Prepared clinical portion of CTD for submission to regulatory agency
• Preparation of IMPD and IB documents (for submission to regulatory agencies) and DC documents (for in-house review) according to strict timelines
• Audited Data Integrity quality control reports for CMC studies
• Completed the nonclinical portions of a CTD submission (written and tabulated summaries) for submission to regulatory agency
2008 - 2009• Preparation of Investigator’s Brochures (IB), Investigational Medicinal Product Dossier
(IMPD) documents for submission to European Union regulatory agency
• Preparation of non-clinical portion of Common Technical Document (CTD) for
submission to US regulatory agency
• Preparation of internal drug development candidate document (for in-house review)
• Performed Chemistry Manufacturing and Control (CMC) Data Integrity audits
2008 - 2008• Instructed nursing students in an allied health program.
• Designed new laboratory facility.
• Developed and implemented courses including curricula, syllabi, lecture presentations and notes as well as laboratories.
• Instituted a virtual microbiology laboratory program and the Art of Observation experience for nurses.
• Established recitation study groups thereby improving student competence without sacrificing course content.
2002 - 2004• Designed and conducted gene therapy experiments for application of an experimental angiogenic adenoviral drug in an animal model of stroke
• Developed stereotaxic brain injection surgery, MR imaging methods and Western Blotting assays for analysis of effects of gene therapy on cerebral vasculature
1998 - 1999• Designed and conducted experiments for magnetic resonance imaging research studies.
• Set up animal protocols according to IACUC regulations.
• Performed small animal anesthesia and surgery.
• Analyzed data and reported results at laboratory meetings.
• Provided technical guidance to undergraduate work-study students in laboratory procedures and techniques.
• Maintained magnetic resonance imaging equipment.
• Responsible for budgets, general laboratory maintenance and organization, supply purchases.
• Assisted in the writing of grant submissions as well as scientific abstracts and papers.
1990 - 1994• Coordinated internal and external high level meetings and corporate events.
• Events were attended by 10-5000 people and occurred daily.
• Hired, trained and supervised team of 50 event facilitators.
• Scheduled and monitored contractual vendors including catering, security, music and décor.
• Developed annual budget submissions and performed basic financial accounting.
