Experience

PharmaPro Consulting

• United States
• Biotechnology Research
• 1 - 100 Employee

• Medical Writer

  • Dec 2020 - Present



Eli Lilly and Company

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Principal Medical Writer

  • Mar 2016 - Jan 2018

  Project Manager responsible for the coordination, vendor oversight, construction, and maintenance of oncology medical slide sets based on Eli Lilly's scientific disclosures for use by Global Medical Affairs liaisons and Medical Information.

• Manager of Medical Writing

  • Jul 2009 - Mar 2016

  Responsible for writing regulatory documents for Lilly's MAb oncology pipeline including protocols, IBs, DSMPs, CSRs, submission documents, and regulatory responses.



ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company

• Biotechnology Research
• 200 - 300 Employee

• Senior Medical Writer

  • Jan 2007 - Jul 2009

  Wrote protocols, protocol amendments, CSRs, abbreviated study reports, data safety monitoring plans, interim safety reports, and patient narratives for Phase 1-3 oncology trials for pipeline and marketed MAb products; revised and wrote initial Investigator’s Brochures and Annual Reports for 4 investigational targeted MAbs; wrote abstracts, slide decks, and posters for international oncology conferences; provided sections for CTAs, IMPDs, and INDs. Performed QC and assisted in formatting of protocols, CSRs, SAPs, DSMPs, CSSs, Clinical Overviews, journal publications, presentations and posters submitted to scientific meetings, training slide decks for oncologists, and medical information reports for sales force. Strong working knowledge of Word, Excel, PowerPoint, Access, Acrobat, Documentum, ISIWriter and FirstDoc for eCTD. Skilled at interacting with a variety of groups including Preclinical, Toxicology, Pharmacology, Formulations, Clinical Research, Clinical Operations, Biostatistics, Drug Safety, and Regulatory Affairs. Show less



Covance

• United States
• Research Services
• 700 & Above Employee

• Medical Writer II

  • 2005 - 2007

  As a Medical Writer II, responsibilities included writing ~1000 patient narratives and coordinating a tracking system for internal oncology/medical review/QA audit; assisted in 6 CSRs (wrote shells, QC of text and tables, responded to QA audit reports); completed a CSR; wrote several quarterly reports for client’s Phase IV pregnancy registry for an educational program. Served as a core team member and client contact for Phase 2 through 4 clinical studies. As a Medical Writer II, responsibilities included writing ~1000 patient narratives and coordinating a tracking system for internal oncology/medical review/QA audit; assisted in 6 CSRs (wrote shells, QC of text and tables, responded to QA audit reports); completed a CSR; wrote several quarterly reports for client’s Phase IV pregnancy registry for an educational program. Served as a core team member and client contact for Phase 2 through 4 clinical studies.



RadPharm

• Princeton, NJ

• Sr. Medical Affairs Specialist

  • 2004 - 2006

  Medical Writer (first full-time position for this company) that wrote 60 radiology core lab protocols (Charters) for pharmaceutical clients oncology trials. Initialized many working standards, identified gaps, and created processes around position. Liaised with clients, RadPharm Project Managers, and Medical Staff to review the medical components associated with study-related documents and site manuals, and acted as Project Manager for selected studies. Tracked physician training records and Controlled Documents (necessary for Image Quality Assessment and Radiology Reads), wrote 3 SOPs, responded to internal and client audits, distributed medical communications between physicians, and trained new employees. Show less



Shelhigh

• Union, NJ

• CRA / Regulatory Specialist

  • Jan 2003 - Apr 2004

  Responsibilities as a CRA included coordinating a multi-center, international clinical trial for an aortic heart valve. Recruited, initiated, and monitored sites. Presented clinical trial to PIs at Investigator Meeting, participated at in-service training of OR staff, and coordinated IRB activities and contracts. Managed the Shelhigh Clinical Trial Database and generated the biostatistics on Clinical Trials data from adverse events (AE/SAE), patient demographics and clinical endpoints for two clinical trials. Responsibilities as a Regulatory Specialist were to write, publish, and submit to FDA: cardiovascular medical device clinical trial protocol amendments; clinical trial annual report; supplements to an aortic valve IDE (investigational device exemption) and pulmonic valve HDE (humanitarian device exemption); proposals for PMA (pre-market module approval) modules for heart valves; and applied for an Orphan Product HUD (humanitarian use device) status for vascular conduits. Wrote and submitted a clinical trial annual report to the DSMB (Data Safety Monitoring Board). Organized the FDA and European CE submissions documents. Show less



American Cyanamid

• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Residue Study Director, Research Biologist

  • Oct 1983 - Jun 2002

  Study Director for 20 agricultural studies to determine pesticide residues in agricultural commodities. Wrote protocols, trained and monitored contractors and core analytical labs for adherence to protocols, GLPs, and SOPs. Wrote 20 Final Reports that were submitted in registration dossiers, in accordance with US EPA, Canadian PMRA, and EU guidelines. Discovery Research Biologist focused in pesticide mode-of-action, particularly in neurochemistry and biochemistry. Wrote protocols, executed studies, collected data, performed statistics, and wrote study summary reports. Identified chemical and biological agents through high capacity screening, laboratory, greenhouse and field trials. Led a bioassay group to determine the efficacy of recombinant baculoviruses, participated in the manufacturing process of recombinant baculovirus in stir-tank bioreactors. Trained and supervised summer interns and biologists. Show less