Dr. Eileen Rojo
Microbiology
Senior Medical Writer(The company name is only visible to registered members)
- Basel
- Switzerland
Personal information
Professional experience (13 years, 7 months)
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Feb 2009
- present
(3 years, 4 months)
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(Only visible for registered members)
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Feb 2009
- present
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Jun 2007
- Feb 2009
(1 year, 9 months)
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ARPIDA AG, http://www.arpida.com
Industry: Medicinal Products
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Jun 2007
- Feb 2009
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Mar 2006
- Mar 2007
(1 year, 1 month)
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Regulatory CMC Documentation Manager
Novartis Pharma AG, http://www.novartis.ch
Industry: Medicinal Products
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Mar 2006
- Mar 2007
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Aug 2004
- Mar 2006
(1 year, 8 months)
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Novartis Pharma AG, http://www.novartis.ch
Industry: Medicinal Products
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Aug 2004
- Mar 2006
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Dec 2000
- Aug 2004
(3 years, 9 months)
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Novartis Pharma AG, http://www.novartis.ch
Industry: Medicinal Products
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Dec 2000
- Aug 2004
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Sep 1998
- Dec 2000
(2 years, 4 months)
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Max Planck Institut für Züchtungforschung, Cologne, Germany, http://www.mpiz-koeln.mpg.de
Industry: Research
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Sep 1998
- Dec 2000
- Employment status
- Employee
Educational background
- Sep 1993 - Sep 1998
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New York University
Microbiology/Molecular biology, M.Sc./Ph.D
eukaroytic transcriptional regulation
- Sep 1986 - Jun 1991
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University of Washington
Microbiology, B. Sc.
- Languages
- English (First language), French (Fluent), German (Fluent)
About me
Objective:
Looking for challenging position that enables me to use my experience as a scientific researcher, communicator, and project manager
Profile
•Working approximately eight years in the pharmaceutical industry, six of which were in a top-tier pharmaceutical firm (research and development)
•Familiar with all aspects of drug discovery and development, am up-to-date with events affecting pharmaceutical businesses worldwide, and knowledgeable about a wide variety of marketed products from both scientific and marketing prospectives
•Have extensive experience in preparing entire New Drug Application (United States), Marketing Authorisation Application (European Union) and New Drug Submission (Canada)
•Highly proficient in drug regulatory affairs, particularly at the pre-clinical/clinical perspective as well as in eCTD submissions
•Gained significant expertise in project management and communications, particularly at the research level
•Adept in medical and scientific writing as well as in conveying key scientific messages, especially to a non-scientific audience
•Proficient in working in simultaneous multi-national, interdisciplinary projects that involve challenging interactions to deliver quality documents under tight timelines
•Organized, efficient team player who is willing to help others in need and is quick to learn new skills
•Consistent in meeting deadlines and can work on multiple projects simultaneously
•Supervised people and helped them accomplish their immediate project goals
•Strong customer focus – proficient in providing communications material that serves the immediate needs of associates
Professional Experience
2007 –2009: Senior Medical Writer, ARPIDA AG, Reinach, Switzerland
•Was key medical writer, document manager, CRO/publisher liaison and project manager responsible for drafting/coordinating submissions of New Drug Application (United States), Marketing Authorisation Application (European Union) and New Drug Submission (Canada) for ARPIDA’s first major pipeline product in 2008
•Wrote and reviewed clinical study reports and protocols (Phase III clinical trials)
•Gained significant experience in writing/reviewing pre-clinical and clinical (efficacy and safety) regulatory documents
•Responsible for preparing regulatory and non-regulatory documents according to corporate and project needs
•Responsible for the coordination, writing, and completion of scientific publications
•Responsible for planning, coordinating, and executing the publication plan
•Reviewed documents for clinical trials submissions and scientific conferences
2006-2007: Regulatory CMC Documentation Manager, Novartis Pharma AG, Basel, Switzerland
•Responsible for writing chemistry, manufacturing, and control dossiers for submission to national health authorities in response to an upcoming clinical trial
•Liaise with scientists in relevant line functions to assure timely receipt of source data for dossier preparation
•Interpret scientific data and translate into comprehensible form in dossier to facilitate better understanding by health authorities
•Responsible for preparing answers to health authority questions that arrive in response to dossier review
2004-2006: Scientific Writer, Research Communications, Novartis Institutes for Biomedical Research, Novartis Pharma AG, Basel, Switzerland
•Gathered scientific content for all NIBR Communications media (electronic and print) for internal and external audiences
•Generated, researched, wrote, and edited articles featuring NIBR scientists and science for internal and external publication
•Worked directly with Communications Managers to identify stories and provide copy as needed to populate communications vehicles
•Interacted directly with scientists and upper-level research management to gather information about scientific advances and issues of interest internally and externally
•Leveraged NIBR stories for use in other communications departments within Novartis Pharma to ensure consistent and complete communications company-wide
2000-2004: Research Investigator, Ophthalmics Division, Novartis Pharma AG, Basel, Switzerland
•Managed few research projects simultaneously and supervised technical assistants to ensure success of project
•Presented project results in a number of internationally recognized conferences in the field of ophthalmology
•Was author of several internal/external publications, one of which was peer-reviewed
1998-2000: Postdoctoral Researcher, Max Planck Institute for Plant Research, Cologne, Germany
•Managed research project which validated the use of an analytic tool in human cells
•Used yeast, bacterial, and cell culture systems as integral molecular biology tools in validating analytic system
•Presented project results in internationally recognized conferences and non-scientific events (e.g, EXPO 2000)
•Published results in peer-reviewed journal in biochemistry
Education
1993-1998:
•Ph.D, Department of Microbiology, New York University, New York, NY, United States
•M.Sc, Department of Microbiology, New York University, New York, NY, United States
1986-1991:
•B.Sc (Bachelor of Science), University of Washington, Seattle, WA, United States
Publications:
•Ottino P, Finley J, Rojo E, Ottlecz A, Lambrou GN, Bazan HEP, and Bazan NG. Hypoxia activates matrix metalloproteinase expression and the VEGF system in monkey choroids- retinal endothelial cells_ Involvement of cytosolic phospholipase A2 activity. Molecular Vision (2004) 10:341-350.
•Rojo-Niersbach E, Morley D, Heck S, and Lehming N. A new method that allows for the selection of protein interactions inside mammalian cells. Biochemical Journal (2000) 348(3) 585-590.
•Rojo-Niersbach E, Furukawa T, and Tanese N. Genetic dissection of hTAF130 defines a hydrophobic surface required for interaction with glutamine-rich activators. Journal of Biological Chemistry (1999) 274(47) 33778-33784.
Accomplishments/Memberships
2008: Membership in European Medical Writer’s Association
2006/2008: Membership in American Medical Writers’ Association (US)
2005: Selected as honorary VIP member in Madison’s Who’s Who
2005: Membership in National Association for Science Writers (US)
2000: Invited Speaker, Shaping the Future Global Dialogue Symposium, EXPO 2000, Hannover, Germany
1998: Postdoctoral Fellowship Grant, Max Planck Institute for Plant Research, Cologne, Germany
Skills
Computer: Word, Powerpoint, Adobe Photoshop, Corel Draw, Excel, Sigmastat, Microsoft Publisher, Origin
Languages: English (native), French (intermediate to fluent), German (intermediate to fluent)
Other Relevant Activities
Editing and layout design of local newsletters for English-speaking expatriate community in Basel (e.g., Basel Childbirth Trust, Centrepoint)
References
References available upon request.
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Contacts
Volkan Kösele, Eva Komenda, Dr. Sara Paulillo, Maria Solonets(More contacts may only be viewed by registered member)