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Doctor in Technical Medical Writer-Author for; Regulatory, Clinical, Research, New Business Development and Expert Witness

Technical Consultant #2569


Expertise

  • Regulatory Medical Writing
  • Clinical Medical Writing
  • Editing
  • Quality Control
  • Business Development

Expert Witness Experience

  • Writing Experience (Phases 1, 2, 3, and 4):
  • Wrote and edited ICH-compliant documents, including investigator brochures (IBs); Investigational New Drug (IND) applications.
  • Marketing Authorization Application (MAA); informed consent documents (ICF); protocols and amendments.
  • Clinical trial agreements (CTAs); clinical study reports (CSRs).
  • Clinical evaluation reports (CERs); biologics license applications (BLA); new drug applications.
  • NDAs), study-specific (governance, protocol deviation, monitoring management).
  • Project Management [PM], and safety monitoring) plans; briefing books; vendor scope of work (SOW) documents.
  • Microsoft PowerPoint slides; and standard operating procedures (SOPs).
  • Therapeutic Indications: Oncology, Rare Disease, and Infectious Disease.

Experience

TGT, New York, NY, Associate Director, 2021 – Present

  • Write, edit, contribute to and manage the development of a variety of clinical regulatory documents, as well as other documents per company needs.
  • Recruit, hire, supervise, and mentor in-house and contract medical writers.
  • Develop documents to support infrastructure (e.g.,, SOPs, style guides, work instructions, and ICH-compliant Word templates). Work with Legal and Finance to negotiate contracts and develop budgets.
  • Ensure smooth and effective document management from start to finish, including but not limited to first draft authoring, coordination of review and adjudication, reference retrieval, generation of bibliographies, adherence to the style guide, and participation in various document processes (eg, QC, formatting).
  • Work closely with internal and external resources to ensure alignment among timelines for related activities, such as data communication, document authoring, document review, QC, publishing, and submission.
  • Review, edit, and ensure the quality of documents or sections of documents prepared by other writers (internal or contractors) or functional area representatives, as required, ensuring adherence to applicable standards and requirements.
  • Partner with subject matter experts and other stakeholders to oversee document review and comment adjudication meetings with cross-functional teams.
  • Support the development, implementation, and improvement of best practices, the document process, and SOPs.
  • Help communicate procedures, operations, and implementation plans to the organization.
  • Distill large amounts of clinical and scientific data into summary text and analysis for clinical documents.
  • Develop and maintain templates and outlines for key documents. 

HKW, Bismarck, ND, Owner, 2018 – Present

  • Author INDs, protocols, DSURs, CSRs, and IB during a year contract as a Senior Regulatory Medical Writer at AbbVie in oncology.
  • Provide leadership during protocol writing activities for 2 separate studies for a client leading the charge to create a vaccine for the COVID-19 pandemic.
  • Independently author 2 class IIa CERs for Cooper Surgical.
  • Manage and coordinate the development of an oncology BLA on hematologic malignancies.
  • Manage and coordinate the development of an oncology NDA. Oversee SME content across 2 teams (one domestic, one international) to ensure compliance of submission and overall quality for small companies' first NDA.
  • Independently author 3 breast cancer CSRs and assisted in the creation of company templates to streamline the process.
  • Collaborate and assist in the writing of 2 class I CERs as a consultant per MEDDEV 2.7.1 revision 4 guidelines.
  • Locate applicable data, analyze study results, synthesize literature, and prepare summaries into formal reports.
  • Conducted literature searches on medical devices, pharmaceuticals, and biologics as requested by the client.
  • Manage the development of Module 2.7.3 and Module 2.7.4 for a client in oncology.
  • Assist in the writing of an observational study CSR on the outcomes of cancer interventions in HIV patients as a consultant.
  • Write and edit an oncology NDA for a company's initial submission as a consultant (GIST).
  • Collaborate and assist in the writing of 2 CSRs for Deciphera Pharmaceuticals (Phase 1/3) for patients with gastrointestinal stromal tumors.
  • Solely write a Phase 1/2 protocol for Weill Cornell Medicine for patients with metastatic castration-resistant prostate cancer.
  • Participated as a part of a cross-functional team to produce a Phase 1 CSR for X4 Pharmaceuticals, where I was delegated sections 7-11 for cutaneous malignant melanoma.
  • Assist in the writing of a Phase 1/2 and Phase 3 CSR for X4 Pharmaceuticals, where I was delegated sections 8-11 for advanced clear cell renal cell carcinoma and metastatic breast cancer.
  • Write/revise CSRs and Protocol Amendment Summary documents.
  • Submit draft work product requiring minimal revisions.
  • Produce good quality and lucid documents, with excellent grammar and logical flow of ideas from a readers' perspective.
  • Provide editorial review for business development documents.

Trial Runners, LLC, Dickinson, North Dakota, Clinical Research Associate, 2017 - 2018

Project Management and Medical Writing Assignments

  • Collaborate with project managers, graphic artists, regional monitors, programmers, editors, and quality assurance specialists to ensure the sponsor's needs are met in all aspects of the study.
  • Review protocol, amendments, and statistical analysis plans. Ensure the appropriate incorporation into reports as necessary.
  • Revise/review training materials created by others for formatting, flow, and educational effectiveness.
  • Oversee document preparation activities.
  • Build and maintain a knowledge base to improve the overall medical content of the protocol.
  • Develop and maintain timelines per the sponsor's request.
  • Prepare reports, manage review cycles, and incorporate comments as appropriate from reviews.
  • Ensure Quality Assurance review of the protocol and any necessary amendments.
  • Review and QC clinical data in-house and communicate with study site/regional monitor for data query resolution.
  • Write, review, and edit company SOPs.
  • Write feasibility questionnaires and confidential disclosure agreements (CDAs) to support clinical study site selection.
  • Write responses to protocol-related questions from study sites and regional monitors.
  • Assist in the development of clinical study forms and templates, including the informed consent form template, study site budgets, case report forms (CRFs), template source documents, training manuals, regulatory and procedural manuals, and other site-specific forms of resources materials.
  • Develop presentations for participating sites in a clinical study
  • Maintain primary communication with regional monitors to ensure compliance with monitoring plans.
  • Assist in the revision of necessary regulatory documents including protocols, IBs, ICFs, study plans, etc.
  • Write meeting minutes for project team meetings.
  • Edit and revise monitoring trip reports for clarity, accuracy, and validity.
  • Support negotiation, revision, and writing of CTAs.
  • Confirm protocol submission to appropriate regulatory authorities, including institutional review boards (IRBs).
  • Track and report clinical study progress to the project manager.
  • Manage clinical study sites to ensure and assess patient enrollment.
  • Collaborate with the Data Management Department to establish database parameters and edit check specifications.
  • Maintain internal clinical study-specific trackers of deviations, enrollment progress, vendor information/activation, monitoring visits, and dosing.
  • Invoice investigator payments and verify pass-through costs; support the preparation of site budgets.

Honors & Publications


Credentials

  • Bachelor of Arts (BA); Major, Biology with honors; Minor, Allied Health Cum laude, Dakota Wesleyan University 

Academic and Professional Affiliations

  • American Medical Writers Association-AMWA

Education

  • OTD  Doctor of Occupational Therapy, Psychiatric, University of Mary, Bismarck, ND
  • B.S. Biology (With Honors-Cum laude), Dakota Wesleyan University, Mitchell, SD
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