Our client is seeking a highly motivated and collaborative individual for a contract (12-18 months) position as a Technical Writer. This candidate will report to the Senior Director, Regulatory Affairs, and will be involved in regulatory submission activity for in-vitro diagnostics (IVD). The candidate’s primary responsibility will be to support cross functional teams in the development, reviewing and editing of regulatory submissions related documentation as well as related quality system documentation – essentially a wide range of documents.
RESPONSIBILITIES / DUTIES:
• Writing, editing and reviewing quality system documents, including SOPs, study protocols and reports, and related regulatory submission documents supporting regulatory filings. • Organizing and incorporating information for documents, such as references, graphics, tables, and data listings. • Represent the technical writing viewpoint within cross-functional meetings.
• Bachelors/Masters in a scientific/technical discipline or equivalent • Medical Device, IVD experience with FDA and International Regulatory Submissions • At least 3-5 years of technical writing experience in the regulated (Medical Device, IVD or Pharma) field; experience in writing, reviewing and editing standard operating procedures or related documents • Strong knowledge of molecular biology and molecular biology methods (e.g. PCR, quantitative PCR, sequencing, ELISA), prior laboratory experience, a plus • Experience writing quality system documentation for Software as a Medical Device, a plus. • Knowledge and/or experience writing technical documentation for software development life cycle (SDLC). • Ability to write with scientific accuracy and to compile, write, and edit documents for submission to regulatory agencies. • Understanding of regulations and guidelines governing IVD products, with a broad knowledge of related topics such as Product Development Reagent Manufacturing and Quality Assurance. • Knowledge of ISO 13485 and related quality system documentation and associated regulatory requirements would be an advantage. • Able to facilitate clear communication with stakeholders • Capable and flexible team player with the ability to effectively cope with the challenges of meeting aggressive deadlines • Proven ability to multitask, collaborate in cross-functional teams, and work independently • Critical-thinker able to address complex situations, issues, and adopt a systemic view of continuous process improvement to reach goals • Excellent working knowledge of English grammar, punctuation and overall writing skills, with the ability to edit content for user-facing documentation • Proficient with Microsoft Word, Excel and PowerPoint
Contact Broad Outsource:
If you meet these qualifications and can fulfill the outlined responsibilities in a virtual/remote setting, please email us with your Technical Writing résumé/CV and a cover letter. [Broad Outsource @ Outlook]