プロフィール詳細

プロジェクトを作成

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Ngovi K.に依頼

Kenya

Serves as medical writing lead on more complex or clinical regulatory documents such as those associated with filings.

プロフィール概要

Managing the business development and pricing projects for Medical Writing Serves as medical writing lead on more complex clinical regulatory documents such as those associated with filings and dossiers. Works closely with the Publications or Regulatory team(s) on document strategies. Implements all activities related to the preparation of publications (e.g. abstracts, posters/oral presentations, manuscripts) or to the preparation and compilation of data and information into a single comprehensive package for new and updated clinicals Serves as a subject matter expert within department for assigned therapeutic/product areas. As assigned, provides direction and guidance to medical writers regarding assigned projects, including review of work product. Provides input and feedback to management regarding internal medical writers' work product/quality. Recognizes potential scheduling and resource conflicts for projects across therapeutic area/product assignments and provides recommendations to resolve Serves as medical writing lead on more complex or clinical regulatory documents such as those associated with filings and dossiers. Works closely with the Publications or Regulatory team(s) on document strategies. Implements all activities related to the preparation of (e.g. abstracts, posters/oral presentations, manuscripts) or to the preparation and compilation of data and information into a single comprehensive package for new and updated clinicals Serves as a department representative on project teams. Acts as Subject Matter Expert for assigned clinical teams regarding computer-based technologies utilized by the respective departments (e.g. eDocs, eCTD, journal/congress databases). Coaches, mentors, and assists medical writers. Provides guidance to non-Abbott medical writers and external vendors/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, writing documents, generating consensus among reviewers, and facilitating discussions. Provide process, content, and submission document planning to the Clinical Submission, Clinical Satellite and Clinical Trial Teams. Advising on resource utilization, efficiencies and timelines Assisting business development in securing new business

専門分野

• ★ Data Analysis
• ★ Nursing Education
• ★ Technology Scouting
• ☆ Farm Management
• ☆ Data Management
• ☆ Physics

サービス

• Writing
• Research
• Consulting
• Data & AI
• Product Development

Writing Clinical Trial Documentation, Medical Writing, Non-Medical Regulatory Writing, Technical Writing, Business & Legal Writing, Copywriting, Creative Writing, Newswriting, Audio Transcription, Translation

Research Market Research, Feasibility Study

Consulting Scientific and Technical Consulting

Data & AI Statistical Analysis, Algorithm Design-Non ML, Data Visualization

Product Development Formulation, Stability/Shelf Life Testing

職務経験

Chief Medical Writer

Upwork Medical Research Team

4月 2011 - 1月 2014

学歴

Clinical Degree

Jomo Kenyatta University

9月 2015 - 9月 2019

Nursing Degree

Jomo Kenyatta University of Agriculture and Technology

5月 2009 - 7月 2014

認定資格

• Adobe Analytics Developer

  Adobe Systems Incorporated

  https://web.skype.com/

  5月 2013 - 現在