Medical Manager

MICHAEL J. BLAZE, PhD

*** ********* *****

Ithaca, NY 14850

Phone: 917-***-****

E-mail: **************@*****.***

Education

PhD, Biochemistry & Molecular Biology

University of Louisville School of Medicine

Louisville, KY 2003

BS, Agriculture and Life Science

Cornell University

Ithaca, NY 1994

Summary of Capabilities

Skilled in the development and submission of Pharmaceutical submissions to the US FDA for approval. Experienced in all aspects of regulatory documentation filing for the registration of Class I, II, and III medical devices in the US as well as foreign countries (Australia, Canada, China, EU, Japan). Proficient in the development of educational and promotional programs empowering health care providers to change habits leading to measurable improvements in patient outcomes. Highly skilled at developing new business initiatives, strategies for a pharmaceutical brand medical communication plan as well as implementing individual tactics including symposia (stand alone or during a medical meeting), advisory board summaries, speaker training, and needs assessments.

Regulatory Writing Experience Includes:

Investigational New Drug Application (INDs) -2 years (2 submissions)

New Drug Application (NDAs) -3 years (2 submissions)

Clinical Study Reports (CSRs) -5 years (15+ reports)

Standard Operating Procedure Reports (SOPs) -5 years (5+ reports)

Prescribing information (PI) for FDA review -5 years (5+ PIs)

510(k) submissions -2 years (5+ 510(k) submissions)

International medical device marketing submissions -1 year (EU, Asia, Canada, Australia submissions)

NCCN industry inclusion submission -2 years (Head & Neck Cancer, NSCLC, CRC)

Narrative Writing Experience Includes:

Whitepapers -7 years (12+ papers)

Publication planning -7 years

Primary clinical research manuscripts -7years (20+ manuscripts)

Secondary review manuscripts -7 years (50+ manuscripts)

Abstracts and Posters -10 years (30 +)

Educational Programs -5 years (Industry, NCCN, web based programs)

Experience

Freelance Medical Writer

Medical / Legal / Technical Writing Experience

Ongoing Position

Responsible for writing a full range of regulatory and medical communications for peer-reviewed journals and other venues, including manual editing, news articles, and copy for web sites. Topics include: Clinical Study Reports, Infectious Disease, Oncology, Whitepapers, Cardiovascular, and Pulmonary Disease, Prescribing information. Products include: publication plans/Gap Analysis; conducting literature searches and interpreting data from clinical trials; producing manuscripts (primary and secondary), abstracts, posters, and sales support materials (clinical monographs); Medical slide kits/presentations; Patent research and preparation. Grant writing totals ranging from 200,000 to over 2 Million.

Regulatory Affairs Specialist

October 2011 – Current

Transonic Systems Inc.

Ithaca, NY

Prepared regulatory assessments for new products and changes to existing products in determining the appropriate regulatory pathway to market. Developed and executed regulatory strategies for US and global registrations and compliance activities of internal and contract production. Supported and/or expedited, or directed the preparation of complex regulatory submissions, including 510(k) submissions. Maintained and improved internal database of historical approval-related documents (such as Design Dossier, Technical Files, FDA submission files) and supporting distributors to attain foreign registration of Transonic products. Interfaced, as needed, with European and Asian Notified Bodies and approval agencies regarding significant changes to products. Prepared and submitted Canadian Device License Applications. Reviewed product labeling and advertising for compliance. Coordinated and participated in routine FDA communications (including conference calls, written Correspondence and meetings). Reviewed product development and clinical protocols to assure collection of appropriate data for regulatory submissions and regulatory compliance. This includes use of appropriate standards, experimental designs, evaluation criteria, and statistical rationale. Assisted in grant writing and clinical study reviews including functional, data, and design reviews.

Lecturer – Methods in Nutritional Sciences

Division of Nutritional Sciences

July 2009 – December 2011

Cornell University

Ithaca, NY

Prepared lecture materials and laboratory sessions focused on introducing analytical skills and technical knowledge necessary for an understanding of two key questions in nutritional science:

o How do we determine nutrient levels?

o How do we measure and interpret nutrient status of individuals and populations?

Stimulated senior nutritional science majors in the understanding of the underlying principles of observational and experimental nutritional methods, their associated problems and pitfalls, and their reliability. Developed a one semester lecture and laboratory session involving student experimentations in human subjects, dietary requirements and measurements as well as the procedures for obtaining and analyzing medical samples.

Scientific Director

MedscapeCME, LLC

New York, NY

March 2008 - July 2009

Responsibilities included: developing new business initiatives attending client meetings, symposia, major medical meetings, and internal team meetings; managing the scientific content development from faculty and that of medical writers in order to insure the highest quality, scientific integrity, and inclusion of required learning objectives and educational teaching points; writing and editing materials, including outlines as needed, ensuring scientific integrity and accuracy of medical/clinical messages; identifying key references and other relevant materials for clients; maintaining content-related/editorial communications with physician-authors. This position was eliminated due to company downsizing.

Director of Product Research

NovaSterilis, Inc

Lansing, NY

July 2007 - Aug 2008

Responsibilities include: leading discussions with current and future customers concerning implementation of patented process into their facilities; continually refine and develop the NovaSterilis process for use across tissue types and medical devices; manage the time and professional growth of the product development team; develop and write scientific grants for federal funding consideration and scientific manuscripts for publication in peer reviewed journals; collaborate with the research team in the development and implementation of a quality control division to oversee and maintain in-house additive and procedural protocols for regulatory review. This position was funded by a NIH grant for one year.

Scientific Manager

ProHealth

New York, NY

Aug 2006 - July 2007

Responsibilities included: developing strategy for current business and participating in new business initiatives attending client meetings, symposia, major medical meetings, and internal team meetings; managing the scientific content development of medical writers in order to insure the highest quality, scientific integrity, and inclusion of core messages; developing of investigator brochures, clinical study reports, and additional promotional materials as required; writing and editing materials, including outlines as needed, ensuring scientific integrity and accuracy of medical/clinical and marketing messages; identifying key references and other relevant materials for clients; maintaining content-related/editorial communications with physician-authors. Departure from this position was due to relocation.

Medical Director

SciMed, LLC

New York, NY

May 2005 - Aug 2006

Responsibilities included: providing leadership, motivation, and direction to the medical affairs division; developing content for a full range of medical education programs (promotional and CME) without supervision; managing the scientific content development of associate and assistant level medical directors to insure quality, scientific integrity, and inclusion of core messages; assisting the parent company, Medical Knowledge Group, in the development of new business pitches and client contacts; established long-term relationships with clients and key opinion leaders across a variety of therapeutic areas.

Manager, Publication Planning

IntraMed

New York, NY

May 2004 - May 2005

Responsibilities included: day-to-day planning and management of scientific publications for all clients; managing the smooth flow of documents between teams, both internal (program management and editorial) and external (clients and authors); developing client-specific, comprehensive publication plans that outlined a defined set of abstracts, posters, and peer-reviewed articles; assisting the Global IntraMed team in new business pitches; initiating literature assessments based on quantitative analysis of relevant abstracts found on various database sources including MEDLINE and BIOSIS; writing and editing outline, draft, and final version including submitting completed article to target journal for review.

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