Manager Sales Representative

DEBRA HORNE

**** ***** ******* ****** ● South Plainfield, New Jersey 07080-3605

Home Phone: 908-***-**** ● ******@*****.***

PROFESSIONAL SUMMARY____________________________________________________

Highly-motivated and self-directed manager (with 6+ years of supervisory experience), and a submissions and scientific writer (with 10+ years of writing experience) that has generated and Qced/edited/proofread various types of documents for potential drugs at different stages of their life cycle from various therapeutic areas. Adept at balancing multiple projects simultaneously in a fast paced environment with ever-changing priorities, domestic guidelines, and international guidelines. Strong leadership, organizational, interpersonal, and communication skills that maximize cooperation and productivity amongst colleagues and direct reports.

EXPERIENCE ________________________________________________________________

CELGENE CORPORATION, Summit, NJ February 2011 to Present

Technical/Scientific Writer, Nonclinical Pharmacology/Nonclinical Development (NCD) (August 2011 to Present)

Write reports for non-GLP (Good Laboratory Practices) nonclinical pharmacology studies conducted within Celgene Translational Development and/or by external collaborators. Write nonclinical pharmacology summaries for investigational new drug (IND), new drug application (NDA), and written and tabulated common technical document (CTD) applications to Health Authorities. Work with relevant line functions to prepare/review and edit/proofread regulatory documents and submissions, including annual reports and Development Safety Update Report (DSURs), Investigator Brochures (IBs), Briefing Books (BBs), Phase I clinical protocols, integrated summaries of efficacy and safety, registration dossiers, company core data sheets, product monographs/package inserts, and responses to health authorities. Review data to determine the appropriate tabular and textual formats, and the clarity, logic and order of presentation. Participate in study and project team meetings and assist the teams in resolving issues related to document preparation. Supervised the NCD Document Specialist group in their daily activities as they finalized study-related reports and put submissions dossiers through workflows in a document repository; make managerial decisions. Work with NCD Document Specialists and Regulatory Operations department to initiate and maintain electronic study report and published literature livelink-based repository, and contribute to the authoring, review, edit, and approval process for electronic documents. Review and/or QC/edit/proofread work of other writers (in-house or contract) for accuracy, quality, focus, and adherence to format and style requirements. Prepare manual documents to describe processes.

QC Compliance Specialist (Consultant), Nonclinical Development (February 2011 to August 2011)

Performed scientific and QC review and data verification on Toxicology, (Safety) Pharmacology, and/or Drug Metabolism and Pharmacokinetics (DMPK) reports and appropriate sections of regulatory dossiers to ensure scientific accuracy and compliance with Celgene standard format. Reviewed study protocols to certify that the regulated studies were compliant with GLPs. Reviewed draft reports and sub-reports to confirm that studies were conducted per the corresponding protocol and according to Sponsor and Client Standard Operating Procedures (SOPs), and that the reports accurately described study methods and results. Identified opportunities for process improvement. Assisted in the review of Nonclinical Development SOPs and Work Practices.

SCHERING-PLOUGH RESEARCH INSTITUTE/MERCK, Kenilworth, NJ March 1996 to December 2010

Scientific Writer/Senior Scientific Writer, Safety Assessment/Drug Safety and Metabolism (January 2005 to December 2010)

WRITER

Prepared DMPK sections of regulatory documents (for domestic and international submissions: CTD written and tabulated summaries, INDs, IMPDs, IBs, BBs, CACs, etc.) for compounds in various stages of development and generated study reports for compounds in discovery. Reviewed compiled regulatory dossiers and attended compound team meetings. Coordinated the review of DMPK protocols and reports. Reviewed and Qced/edited/proofread DMPK clinical and nonclinical study reports, manuscripts, and regulatory documents for format, organization, and scientific content. Worked closely with Drug Safety colleagues and extracted data from Toxicology reports after reviewing them. Created standardized document templates and implemented their use to more easily facilitate the document preparation process.

● Maintained balance between supporting an average of eight development compounds a year (by preparing the necessary dossiers) and managing the publishing group

● Devoted member of a submissions team that received approval to market a drug worldwide

MANAGER

Supervised the DMPK Document Publishing group in their daily activities as they published supporting documentation and submissions dossiers in a Documentum-based repository; made managerial decisions, conducted 6- and 12-month reviews of four direct reports and documented performance evaluations.

● Accepted transfer of publishing group supervisory responsibility, saving the company the salary of one full-time employee

● As a member of publishing teams and as a manager, implemented the use of updated publishing software that allows the publishers to increase productivity, finalizing increasing numbers of higher quality documents in less time

DEBRA HORNE PAGE 2

SCHERING-PLOUGH RESEARCH INSTITUTE/MERCK (Continued)

Scientist I-Technical Writer/Associate Scientific Writer I, Drug Safety and Metabolism (March 2001 to December 2004)

Prepared DMPK study-related reports and regulatory dossiers. Scientifically reviewed and edited data, information, and references contained in such documents to ensure accuracy. Created study-related document templates (e.g. study reports and protocols) and assisted authors in writing and properly formatting these in support of submissions.

● Tracked documents from DMPK Submissions Writing group to ensure that timelines were met, thereby creating a more positive group image.

Assistant Scientist/Scientist I, Drug Metabolism and Pharmacokinetics (August 1996 to February 2001)

Wrote and/or reviewed/edited/proofread documents (e.g. study reports, protocols, study plans, SOPs, book chapters, and manuscripts). Generated laboratory procedures, updated them, and distributed modified versions. Assisted contract research organizations in the performance of studies and writing of related study reports. Conducted in vitro incubations with freshly-prepared microsomes, subcellular fractions, hepatocytes, and organ slices in order to scale up the production of metabolites for identification. Studied transport and absorption of development compounds. Performed solid phase and liquid-liquid extractions and high performance liquid chromatographic (HPLC) analyses. Maintained detailed study notebooks and trained lab personnel. Purchased lab supplies and equipment, and updated documentation for all test articles.

● Proposed the idea and set up the in-house use of cryopreserved human hepatocytes for incubation, saving the company the cost of contracting studies using freshly-isolated human hepatocytes and the time waiting for an appropriate organ donor

Temporary Assistant Scientist, Drug Metabolism and Pharmacokinetics (March 1996 to August 1996)

Set up, optimized, and implemented the use of a Western blotting system (for quantification of cytochrome P450 induction or inhibition)

SARSTEDT, INC., Newton, NC October 1995 to March 1996

Sales Representative, Research Division

Assisted laboratory researchers in the purchase of specialized laboratory supplies and equipment

EDUCATION

DOUGLASS COLLEGE, RUTGERS UNIVERSITY, New Brunswick, NJ

B.A. in Biology

TECHNICAL SKILLS__________________________________________________________

Excellent Written and Oral Communication

Highly Capable of Managing Changing Priorities and Working Under Pressure

Superb Organizational Skills, Detail-oriented

Proficient Both as a Team Player and While Working Independently

Computer Skills (Documentum-based software; MS Office including Word, Excel, PowerPoint, and Outlook; SigmaPlot)

PUBLICATION

Gmitter D, Brostrom CO, Brostrom MA. Translational suppression by calcium ionophores: Reversibility and roles of calcium mobilization, calcium influx and nucleotide depletion. Cell Biol Toxicol 1996;12:101-13.

REFERENCES FURNISHED UPON REQUEST

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