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Congresses ~ Publication Plans ~ Staff Leadership ~ Regulatory Affairs ~ Medical Education
Offer significant expertise in publication development, regulatory affairs, strategy development, quality control and assurance (QC/QA), due diligence, project management, and process improvements.
Substantial knowledge of the drug development process, drug laws, regulations, and guidelines.
Highly skilled at directing all phases of regulatory submissions, and particularly adept at interacting and negotiating with FDA and other national health authorities.
Well-developed analytical, troubleshooting, documentation, reporting, and organizational skills
Draw upon strong interpersonal skills to train, direct, supervise, motivate and empower cross-functional personnel to achieve business goals.
Sanofi Genzyme Corporation Cambridge, Massachusetts, 2008 to Present
Associate Director, Global MS Medical Communication & Education, Aubagio and Franchise (2016 to Present)
Spearhead development of global medical communications plan and $2M budget for Aubagio and franchise in Multiple Sclerosis (MS) according to established timelines, procedures, and high quality standards.
Formulate comprehensive educational and medical materials supporting disease state, treatments, and clinical data, effectively using keen project management skills to seamlessly track and coordinate activities.
Update, verify, and expeditiously disseminate global scientific platform to ensure strategic alignment and scientific accuracy across all global and regional communication resources.
Establish detailed congress plans, drive franchise and Aubagio medical communications brand planning, and extensively contribute to internal medical affairs planning.
Strategically collaborate with vendors and service providers in medical content planning and execution.
Oversee all facets of agenda development, content creation, and execution for educational symposia and internal meetings and summits.
Actively promote cohesive efforts among medical communications senior manager, fellows, and medical communication agencies to achieve or exceed mutual goals.
Diligently ensure scientific communication points and key data are included appropriately in tactics, and that statements and conclusions are accurate and fully supported by appropriate data.
Hold significant accountability for Global Scientific Communications section of MS Global Portal (SharePoint) which is accessed by affiliates worldwide.
Optimize information sharing by orchestrating development, review, and distribution of monthly newsletter.
Associate Director, Global MS Publications, Lemtrada (2015 to 2016)
Steered strategic development of medical, clinical and scientific data dissemination efforts in close cooperation with cross-functional teams and internal stakeholders spanning multiple regions and countries.
Played an integral role in planning and execution of global scientific communication points and global publication strategic and tactical plans, as well as global medical congresses, in a fast-paced environment.
Aligned, mobilized, engaged, and drove collaborating co-authors, external experts in MS, and internal resources toward crafting successful publications for Alemtuzumab and pipeline science products.
Controlled $2M budget for Lemtrada, governed development of annual global publications plan, and facilitated updates to publications-related internal guidance and resource documents.
Effectively navigated compilation of high-quality abstracts, posters, presentations, and manuscripts.
Employed strong project management expertise to coordinate vendors and external/internal resources encompassing Genzyme contributors, meeting planners, and Medical agency in development of data and publications for scientific congresses.
Identified and solicited external neurologists and MS experts as authors for publications and abstracts.
Consistently ensured publications conformed to high ethical standards and industry guidelines (e.g., ICMJE and GPPs), as well as stringent internal policies and procedures.
Manager, Regulatory Affairs (2010 to 2015)
Promoted to serve as global regulatory lead for two anti-CD52 monoclonal antibodies, proficiently steering compliant development, registration, and complete lifecycle management efforts.
Directed and executed submission of major US (sBLA, IND), EU (MAA, IMPD), and other global applications and dossiers by driving cooperative efforts among global regulatory affairs and internal staff.
Led development of strategy and materials to prepare for FDA negotiations; prepare teams for negotiation meetings; and coordinate and interact directly with FDA.
Designed presentation materials for FDA advisory committee and determine core presentation strategy and perform in-meeting slide triage for efficacy, study design, clinical pharmacology, and non-clinical disciplines.
Independently handled preparations for pre-submission meetings, coordinated meeting logistics, reviewed and approved labeling and responses to healthy authority questions.
Directed strategic planning activities and lead submissions for international marketing application plans.
Presented with Sanofi Genzyme Alpine Award for 2014 contributions.
Guided development of non-clinical, clinical, and technical documentation such as clinical study reports, protocols, company core data sheets, labeling, investigator brochures, and financial disclosure for all types of communications and submissions.
Oversaw post-approval commitment and medical affairs study protocols and scientific communications including conference and training materials and medical science liaison materials.
Senior Regulatory Affairs Associate (2008 to 2010)
Helmed global regulatory affairs for product designed to treat osteoarthritis of the knee.
Directed staff in preparing and submitting clinical trial application documents, marketing applications, supplements, design dossiers, amendments, annual reports, responses to questions, and product labeling.
Compiled document packages for regulatory submissions and liaised with FDA.
Demonstrated outstanding skills in design control, risk analysis, CMC (Chemistry Manufacturing and Controls) change control assessments, authoring procedures, and devising product development plans.
Delivered presentations on regulatory activity status to steering committees and program meetings.
Amgen Inc. West Greenwich, RI, 2002 to 2008
Senior Associate, Regulatory Affairs (2007 to 2008)
Directed, supervised and monitored development of CMC Electronic Common Technical Document (eCTD) file for a major initial supplemental Biologic License Application (sBLA) and life cycle submissions.
Defined product submission timelines, collaboratively evaluated change controls, participated in content of documents for submissions, and reported on status to senior management.
Senior Associate, Regulatory Compliance (2005 to 2007)
Helmed preparation and management activities for regulatory inspections and internal audits.
As lead internal auditor, devised annual site audit schedule, delivered final audit reports to management, reviewed responses, and tracked audit commitments through to timely closure.
As war room general, managed set-up and implementation of all roles and administration including potential risks, mitigation strategies, and preparing staff through interviews, mock facility tours and training sessions.
Functioned as lead compliance representative for Quality laboratories.
Authored subsections and coordinating revision of site master file for 2005 EMEA inspection.
Associate II, Quality Analytical Laboratories (2002 to 2005)
As Subject Matter Expert for Laboratory Information Management System (LIMS) project, created strategy, authored scripts, assembled LIMS templates, compiled business use cases and performed gap analyses; successfully earned high performance recognition upon project completion.
Master of Science in Quality Assurance and Regulatory Affairs, Temple University, Philadelphia, PA, 2008
Bachelor of Science in Biology, The George Washington University, Washington, DC, 2001
Regulatory Affairs Certification (RAC), 2011
Medical Devices CE Marking Certification, BSI, 2008
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