PharmStatus.com - Regulatory Document Preparation

SUMMARY:
Computer-savvy medical writer and project manager with extensive academic and scientific background.

EDUCATION:
Ph. D., December 1998, Biophysics, University of California, San Francisco (Biomolecular structure, function, and modeling
B. A., Physics, University of California at San Diego

PROFESSIONAL EXPERIENCE:

Regulatory Medical Writing/Project Management

CRO (The Larvol Group) for Johnson and Johnson, Langhorne, PA (http://www.jnj.com/connect 2006-2008)

• Supervised a team of medical writers producing adverse event narratives for the safety section of Clinical Study Reports with a focus on special safety considerations specifically requested by the FDA.
• Team produced 900+ adverse event and special safety narratives per month for FDA and EU submissions.
• Wrote and maintained SOPs and templates
• Was responsible for the QC/QA and final edits.
• Coordinated with the client’s data management and computing to map related documents including unlocked and locked databases, CIOMs (manufacurer’s control documents), multiple clinical trial protocols for the same submission.
Contributed to sections of the clinical study reports including protocols.
• Phase III Clinical trials to assess the safety and efficacy of 4 marketed CNS medications for approval from the FDA for new indications (NDAs).
• Acted as client liaison and was responsible for team management and timely delivery of documents to meet client milestones

Independent Consultant (2003-present-intermitant)

Non-regulatory Medical Writing and Pharmaceutical Intelligence

Alarm Pharm, San Francisco, CA (www.alarmpharm.com)

Technical writer focusing on cancer, type I diabetes, epilepsy, and autoimmune disease.

Assessed technology of protein drug development for white papers, strategic planning, and grant proposals for small to medium biotechnology companies.

Developer and writer for daily secondary source oncology pipeline information for Genentech, S. San Francisco, CA.

The Larvol Group, LLC., San Francisco, CA (www.larvol.com)

Project manager and editor for weekly secondary source market reports on oncology, epilepsy, pain, schizophrenia, and type II diabetes drugs.

I.S.I.S. Inc., San Francisco, CA (www.isisglobal.com)

Gathered primary source intelligence coverage of cancer conferences.

High Tech Business Decisions, Inc., San Jose, CA (www.hightechdecisions.com)

Analyst and writer gathering primary market research intelligence on biopharmaceutical GMP contract manufacturing, disposable technologies, high throughput screening, and electronics manufacturing.

Medical Research (1989 –1990)

University of California, San Francisco (http://www.ucsf.edu/radonc)

As Medical Physicist, was a part of a clinical team for the treatment of cancer in subjects using radioactive implants and focal beam radiation for the treatment of cervical and brain tumors. Calculated dosing, planned treatment, and analyzed efficacy.

ACADEMIC EXPERIENCE:

Faculty Researcher, Institute for Cellular and Molecular Biology, The University of Texas, Austin, TX (http://www.utexas.edu) (2003 – 2006)

Wrote and published articles in peer-reviewed journals on research involving structures of large RNA protein assemblies. Taught courses to instruct graduate students on how to interpret research literature and how to present research.

Research Associate, Department of Molecular Biology (1998-2001)

The Scripps Research Institute, La Jolla, CA (http://garbanzo.scripps.edu/nmrgrp)

Wrote and published articles in peer-reviewed journals on research involving protocols for the calculation of protein structures using NMR data.

Research Assistant, Department of Biophysics (1990-1998)

The University of California, San Francisco (http://biophysics.ucsf.edu)

Wrote and published articles in peer-reviewed journals on research involving structural determination of nucleic acids.

SKILLS/QUALIFICATIONS:

• Well-versed in FDA, EU, and ICH guidelines
• Excellent verbal and written communication adhering to AMA style and excellent organizational and management skills
• Proficient in WHOART and MEDdras terminology
• Ability to work with wide ranging departments and groups to direct projects toward milestones
• Commitment to utilize resources creatively in order to meet or exceed deadlines while managing multiple projects
• Well-versed in Microsoft Word, Microsoft Excel, Adobe Acrobat, and PowerPoint software
• Computer literate with familiarity with C++, Fortran, HTML, Perl, and ECM Documentum

RECENT PEER REVIEWED PUBLICATIONS:

Dai L, Chai D, Gu SQ, Gabel J, Noskov SY, Blocker FJ, Lambowitz AM, Zimmerly S (2008) A three-dimensional model of a group II intron RNA and its interaction with the intron-encoded reverse transcriptase. Mol. Cell 30(4):472-85. http://linkinghub.elsevier.com/retrieve/pii/S1097276508002360

Blocker FJ, Mohr G, Conlan LH, Qi L, Belfort M, Lambowitz AM (2005) Domain structure and three-dimensional model of a group II intron-encoded reverse transcriptase. RNA. Jan;11(1):14-28. http://www.rnajournal.org/cgi/content/abstract/11/1/14

Guo YY, Blocker F, Xiao F, Guo P (2005) Construction and 3-D computer modeling of connector arrays with tetragonal to decagonal transition induced by pRNA of phi29 DNA-packaging motor. J Nanosci Nanotechnol. Jun; 5(6):856-63. http://www.ncbi.nlm.nih.gov/pubmed/16060143

RECENT REPORTS:

Shauna Farr-Jones and Forrest Blocker, What strategies will yield novel treatments for autoimmune disease? Spectrum, Drug Discovery and Design, Decision Resources, March 17, 2008. http://www.decisionresources.com/stellent/groups/public/documents/abstract/08h502-abstract.hcsp

Biopharmaceutical Contract Manufacturing 2007: Quality, Capacities and Emerging Technologies, the Comprehensive Report. Presented by HighTech Business Decisions. Contributing Analyst http://www.hightechdecisions.com/documents/2-FWDPGS-BioCM07_000.pdf

High Throughput Screening 2007: New Strategies, Success Rates, and Use of Enabling Technologies, the Comprehensive Report. Presented by HighTech Business Decisions. Contributing Analyst

http://www.hightechdecisions.com/documents/HTS2007TableofContents.pdf