More then 14 years of experience working in biotechnology industry in a variety of managerial positions within Medical and Regulatory Affairs, Clinical Research, Commercial Development and Marketing. Most recently, as Director of Medical Communications for Favrille, Inc., my responsibilities included the design, build and management of our tradeshow booth at several major annual conferences, as well as planning and execution of variety of meetings with KOLs, investigators, advocacy groups, advisory boards, etc. Additionally, I was responsible for the publication strategy and management and also served as the patient advocacy and outreach liaison as well. Prior to transferring into the Commercial side of the business, I was Sr. Manager, Clinical Projects. In this capacity, I was responsible for study start-up activities for each of Favrille's clinical trials, from site selection, through IRB approvals and site contract and budget negotiations. As part of this effort, Favrille enrolled a 350+ person Phase III trial in less than 18 months.Previously, while working at IDEC Pharmaceuticals during the development of Rituxan, I managed the Clinical Documentation department and was part of the small team of employees sent to Washington DC for the BRMAC (now ODAC) Committee meeting prior to Rituxan's approval.Specialties: Meeting Planning (national and international)Congress/Convention managementExcellent computer skills, including PowerPoint, Word, Excel, Photoshop, OutlookContract Negotiation Ability to juggle multiple complex projectsExcellent management skillsStrong written and oral communication skills
Favrille
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Director Of Medical CommunicationsFavrille Aug 2001 - PresentI am resposible for managing all of our activities at major industry congresses and conventions nationwide. Additionally, I plan and execute all meetings for the Commercial and Clinical departments, including KOL meetings, advisory board meetings, investigator meetings, etc. Additionally, I am the Publication Manager. It is my responsibility to plan the publication strategy, manage the development of abstracts, manuscripts, poster and slide presentations and I assist with the development of all educational material displayed in our tradeshow booth and on our investigator and patient internet portals. Another aspect of my position is that of Patient Liaison /Outreach Representative. In this role I am the conduit between the company and the advocacy groups as well as any of our patients who may wish to become an advocate for our lead candidate product during its upcoming approval.
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Sr. Manager, Clinical ProjectsFavrille Aug 2001 - PresentIn this role, I was responsible for all of the study start up activities for each of Favrille's clinical trials, including site qualifications and selection, all regulatory paperwork through IRB approval, and all contract and budget negotiatios for each of our clinical sites. Of particular note was our accomplishment of enrolling a 350+ patient oncology study in less than 18 months.
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Manager, Site ContentBioq.Com May 2000 - Jun 2001BioQ was a company developing software to support the lifesciences/biotechnology industry. My responsibility was to identify content available on the internet that people within these industries would be interested in receiving each day, delivered directly to their desktop without searching for it. It was important to be famliar with CFR part 21 and other regulatory guidelines.
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Manager, Investigator Site ResourcesQuintiles Transnational, Cns Therapeutics Feb 1999 - Feb 2000Managed more than 20 employees in the process of starting up large studies for a multitude of sponsor pharmaceutical and biotechnology companies. Wrote Master Investigator Agreements and Informed Consents for each study. Negotiated investigator site contracts and routinely negotiated budgets in excdess of $500,000.
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Supervisor, Clinical DocumentationIdec Apr 1996 - Feb 1999Managed eight employees in the production of all clinical documentation for the Medical and Regulatory Affairs Division. Prepared and administered departmental budget. Provided customer service interface between Clinical Documentation and Regulatory Affairs, Biometrics, and Clinical Trials. Ensured quality, accuracy, and uniformity of all documents submitted to the FDA. Electronic Submission Committee member.
Susan Langley Education Details
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Business Administration (Hr Emphasis)
Frequently Asked Questions about Susan Langley
What company does Susan Langley work for?
Susan Langley works for Favrille
What is Susan Langley's role at the current company?
Susan Langley's current role is Congress and Event Director / Meeting Planner.
What schools did Susan Langley attend?
Susan Langley attended National University.
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Susan Langley
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