Regulatory Medical Writer and Editor Specialist

D. Joan Smith (AKA Jody Smith) MA

**** *. ******* ******, ************, PA 19129

Phone: 215-***-****; cell: 267-***-****; email: ****-*****@*******.***

Seeking Position in Regulatory Medical Writing/Editing

I offer solid experience in writing documents that advance a new drug from the proposal stage to a marketed pharmaceutical product. My medical writing career spans 25 years. I began by working at Wyeth where I collaborated in writing 3 successful NDA submissions. Skill in shifting between different therapeutic areas was gained by working at CROs. Overall, I have participated in 9 NDA submissions.

I am knowledgeable about grammar and punctuation that are consistent with the AMA Manual of Style and programs for document formatting. I make certain that documents are well edited and are correct, clear, concise, consistent, and are delivered on schedule to my colleagues using systems such as SharePoint.

Document Writing and Editing Experience

Clinical Protocols Module 2.5 Clinical Overview

Clinical Study Reports Module 2.7 Clinical Summar

Investigational New Drug Reports Participant Safety Narratives

Investigators Brochures Periodic Update Safety Reports

Marketing Authorization Applications Responses to FDA Questions

Medical Device CERs Updates to SOPs

Education

MA Clinical Psychology, University of Pennsylvania, Philadelphia, PA (Awarded a Commonwealth of Pennsylvania Stipend for Professional Training)

BA Psychology and Chemistry, Westminster College, New Wilmington, PA (Magna Cum Laude)

Professional Employment

Senior Medical Writer, Worldwide Clinical Trials, Austin, TX (10/2020 – 5/2024, Remote Position)

Successfully wrote and delivered on schedule phase 1 Protocols and Clinical Study Reports related to the safety and pharmacokinetic/pharmacodynamic properties of new drug products being developed in multiple therapeutic areas. Collaborated with medical monitors, project managers, and statisticians through 2 or 3 cycles of document revisions. Skilled in document formatting and using SharePoint. QC reviews of documents written by peers and in training entry-level writers. Collaborated in revising the phase 1 protocol template and updating medical writing SOPs.

Medical/Regulatory Writer III -QPS LLC, Newark, DE (10/2014 – 3/2020, Remote Position)

Wrote phase 1 Protocols and Clinical Study Reports related to the pharmacokinetic properties and safety of drugs under development for the treatment of neuropathic pain, neurological conditions, rheumatoid arthritis, prostate cancer, cardiac disorders, skin irritation, pregnancy complications, and drug-drug interactions. Provided QC reviews of documents written by peer writers and a medical writer I. Determined schedules for medical writing deliverables. Collaborated in revising templates, improving data presentations, and updating SOPs.

Medical Writer. Otsuka Pharmaceuticals, Princeton, NJ ( 04/2012 - 12/2012, Remote Position)

Authored the early protocol drafts for brexpiprazole and sertraline before the company decided to allow their partner Lundberg Pharmaceuticals, Inc. in Deerfield, Il to accelerate the development of these products as treatment for post-traumatic stress disorder.

Medtronic Inc, Winter Park, FL (01/2011 - 11/2011, Medical Writer, Remote Position)

Wrote Clinical Evaluation Reports submitted to the FDA. These reports included recommendations based on 5-year literature reviews of the efficacy and safety of 2 types of electrocautery devices.

J & J, Risk / Benefit Division, Horsham, PA (5/2010 –10/2010, Quality Control Reviewer of PSURs, Remote Position)

W-2 Employee of RHO Incorporated, 507 Omni Drive, Hillsborough, NJ. Wrote and revised for accuracy Periodic Safety Update Reports that provided post-marketing pharmacovigilance information. Checked consistency of post-marketing reports that described adverse drug experiences, serious adverse events, narratives, and responses to Regulatory Agencies.

Principal Clinical Writer, Premier Research, Philadelphia, PA (08/1999 – 02/2004, On-site)

Wrote documents similar to the Wyeth assignments (see below). Contributed to 4 NDAs: Adderall, Concerta, and the Daytrana patch for ADHD and Xyrem (gamma-hydroxybutyrate) for narcolepsy.

Principal Clinical Writer – Wyeth Research, Radnor, PA (08/1989 – 08/1999, On-site )

Promoted 3 times; Rehired in 2007 as a Consultant Writer for the Pristiq NDA

Wrote phase 1 to phase 3 Protocols and Clinical Study Reports, as well as Investigators Brochures, clinical sections of INDs, IESs, ISSs, FDA Responses, and PSURs. Experienced working in CNS, cardiovascular, antiinflammatory, and women’s health. Experienced using Documentum.

Supervised phase 1 clinical project teams within the medical writing department and full cross-discipline project teams. Participated in clinical project teams in the US, England, Canada, and Taiwan.

Delegated tasks and coordinated the writing activities of 5 medical writers, leading to the completion of IESs for 3 NDAs (Effexor, Ativan for Status Epilepticus, and Sonata)

Collaborated with principal investigators in the preparation of journal articles.

Recognized with a Wyeth Outstanding Award (very selectively given across the company).

American College. of Radiology, Phila., PA, Clinical Data Manager -12/1988 – 07/1989 (On-site)

Collaborated with a statistician in writing grant proposals submitted to the National Cancer Institute.

University of PA Medical School, Department of Clinical Epidemiology, Data Manager – (On-site)

Supervised data collection/coding on a J&J study conducted in 26 countries on the safety of ethylene oxide when used as a sanitizing agent.

Professional Affiliations

Member - American Psychological Association

Member - American Medical Writers Association

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