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Efficient Technical Writer with over 10 years of experience. Extensive understanding of technical research and updating records. Adept at distribution and adaptation to audiences.
· Good computer skills and skilled with client templates; Good knowledge of document management systems and other relevant applications (e.g. Excel, Outlook) · Able to quickly acquire working knowledge regarding a variety of scientific/medical fields · Basic knowledge of statistics, basic data interpretation and presentation skills · Detail-oriented. Methodical. Goal-driven. Good judgment. Able to work with minimal supervision · Good knowledge of regulatory documentation and drug development process · Good interpersonal skills. Ability to work within a team · Knowledge of medical terminology and basic statistical/clinical concepts · Competence in completing good first draft technical reports or clinical reports within a reasonable timeframe with limited guidance · Strong interpersonal skills and the ability to be flexible in varying environments and with multiple customer groups · Cognitive abilities including; verbal reasoning, attention to detail, critical thinking, and analytical ability
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Principia Biopharma Inc. – Knoxville, TN,
Managing the business development and pricing projects for Medical Writing
•Serves as medical writing lead on more complex clinical regulatory documents such asthose associated with filings and dossiers. Works closely with the Publications orRegulatory team(s) on document strategies. Implements all activities related to thepreparation of publications (e.g. abstracts, posters/oral presentations, manuscripts) or tothe preparation and compilation of data and information into a single comprehensivepackage for new and updated clinicals
•Serves as a subject matter expert within department for assigned therapeutic/productareas. As assigned, provides direction and guidance to medical writers regarding assignedprojects, including review of work product. Provides input and feedback to managementregarding internal medical writers' work product/quality. Recognizes potential schedulingand resource conflicts for projects across therapeutic area/product assignments andprovides recommendations to resolve
•Serves as medical writing lead on more complex or clinical regulatory documents such asthose associated with filings and dossiers. Works closely with the Publications orRegulatory team(s) on document strategies. Implements all activities related to thepreparation of (e.g. abstracts, posters/oral presentations, manuscripts) or to thepreparation and compilation of data and information into a single comprehensive packagefor new and updated clinicals
•Serves as a department representative on project teams. Acts as Subject Matter Expert forassigned clinical teams regarding computer-based technologies utilized by the respectivedepartments (e.g. eDocs, eCTD, journal/congress databases). Coaches, mentors, andassists medical writers. Provides guidance to non-Abbott medical writers and externalvendors/agencies. Recommends, leads, and implements tactical process improvements,both within the department and division-wide
•Manage the review and approval process of clinical submissions documents, writingdocuments, generating consensus among reviewers, and facilitating discussions. Provideprocess, content, and submission document planning to the Clinical Submission, ClinicalSatellite and Clinical Trial Teams. Advising on resource utilization, efficiencies andtimelines
•Assisting business development in securing new business
Parexel – Homestead, FL,
· Provide scientific expertise to Business Development in the development of new business pitches and proposals
· Assist Business Development team with the preparation of proposals and cost estimates for medical writing tasks
· To assist Senior Management to assess functional operations and plan for new procedures
· Communicates with and works effectively and productively with all authors on the development of scientific publications
· Ensures publications are developed in accordance with the established time lines
· Develop detailed time lines for document development in line with team and company goals and procedures
· Assist Business Development with the preparation of proposals and cost estimates for medical writing tasks.
Agendia – Indiana, PA,
- Adapted writing style to suit primary and secondary care physicians, specialists, nurses, patients and other stakeholders.
- Collaborated with clinicians, clinical scientists and biostatisticians to interpret study results and accurately reflect in relevant documents.
- Reviewed projects for scientific accuracy to align with project brief and incorporate internal and client or author feedback.
- Combined thorough understanding of therapeutic area with product strategy to meet communication objectives on assigned projects.
- Interpreted and synthesized large amounts of scientific data to create compelling messaging, scientific stories and narratives that aligned with client business goals.
- Proofread copy written by colleagues to correct spelling, punctuation and grammar.
- Organized material to research and complete writing tasks.
- Presented new technology and drafted white papers and other technical documents to complete packages.
- Communicated with customer representatives for feedback and distribution.
- Observed in-progress operations to identify important steps for technical instructions.
University of Washington - Seattle, WA
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School Attended
- University of Washington
Job Titles Held:
- Principal Medical Writer
- Senior Medical Writer
- Medical Writer
Degrees
- Bachelor of Science
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