Technical Writer with clinical background

Melissa Germinara

*** ******** **** 845-***-****

Chester, NY 10918 ***********@*******.***

http://www.linkedin.com/in/melissagerminara

TECHNICAL WRITER/PHARMACEUTICALS

Pharmaceutical professional with expertise in technical writing, regulatory compliance and quality control/assurance. Experience writing testing documents, Annual Product Reviews, Stability Reports and SOPs. Strong scientific background includes drug development from early compound selection through marketed product for testing and stability, method development and validation. Analytical in approach, committed to completing all projects in a timely manner and with a high degree of integrity. Flexible and adaptable to changing priorities and regulations. Able to work independently.

Documentum Trackwise SAP Visio

ICH Guidances Dragon eSOP ISI Writer

FDA Microsoft Office Sharepoint

EXPERIENCE

Eisai Pharmaceutical

Contract Medical Writer April, 2016 - Present

Performed quality control review of clinical study reports, protocols, protocol amendments, safety update reports and investigator brochures including format. Provided change summary on protocol amendments.

Novartis Pharmaceuticals

Sr. Technical Writing Specialist October, 1999-June, 2015

Coordinated, prepared, corrected, updated and issued testing documents for Novartis Quality Control, third parties and global customers with regulatory focus. Created and updated laboratory worksheets and SOPs. Prepared Annual Product Review reports. Supported CMC regulatory, manufacturing, purchasing, quality and development personnel. Single point of contact for all Suffern testing documents for drug products, raw materials, packaging materials and medical devices. Familiar with TEDI, DRAGON, AQWA, eSOP, SAP, Project management software, FDA and ICH guidances.

Updated and maintained testing document and worksheet databases

Single point of contact for USP/Ph. Eur./JP from review to implementation at site

Reviewed and implemented Global Quality Modules/Directives

Managed and completed multiple projects

Supported product launches by reviewing and updating all required documentation

Responsible for supply of all testing documents to Suffern Site

Recognized SME for technical and scientific information

Trained and supervised staff and intern

Supplied quality documents critically needed quickly

Authored many technical documents for regulatory filings

Reviewed regulatory content for department personnel before filing

Created and updated SOPs to meet regulatory compliance standards

Provided drug substance and drug product information for Monographs to USP

Created many change controls to support changes of testing documents

Product Administrator 1997 – 1999

Prepared annual stability review and specialty reports for marketed products. Provided stability support for QC, manufacturing, regulatory and compliance. Working knowledge of GLPs, GMPs and ICH guidelines. Familiar with Microsoft Office programs, proprietary LIMs, SAS and data retrieval systems.

Chairperson of the Stability Evaluation Committee including stability project management responsibilities

Completed many stability annual product review reports

Wrote several stability out-of-specification notifications

Physically stored drug product and drug substance materials into stability chambers and pulled samples for stability testing

Oversight of stability chamber function

EARLY CAREER EXPERIENCE AT NOVARTIS

Supported regulatory, clinical and other groups by developing analytical methodology and providing sample analysis for early development compounds through marketed drug products. Developed and validated methods for NCEs and formulated products. Isolated quantities of minor impurities for further identification. Extensive experience with HPLC, GC, TLC, UV/Visible and FT-IR instrumentation as well as wet chemical techniques. Experienced in NMR, TGA and DSC and Chromatography Software. Class training in Capillary Electrophoresis Chromatography.

Prepared technical reports for IND submissions and NDAs and assisted in the preparation of the Investigator’s Brochure.

Represented Analytical Development on multi-disciplinary project teams

Developed and validated many test methods for early development compounds and intermediates and for clinical supplies

Created several analytical reports for IND filing

Performed testing by USP

Calibrated laboratory equipment

TECHNICAL SKILLS - LABORATORY

HPLC GC TLC

UV/Vis FT-IR NMR

TGA DSC

EDUCATION

Regulatory Affairs Certification (RAC) – June, 2016

Master’s in Public Health (MPH) Epidemiology, NYMC-School of Public Health, Valhalla, N.Y.

MS Chemistry, Long Island University, Dobbs Ferry, NY

BS Chemistry, State University of NY, Oneonta, NY

Studied French, German, Russian and Chinese languages

ASSOCIATIONS

Member Regulatory Affairs Professional Society

Melissa Germinara – Page 2

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