Regulatory Writing Mgr

2 weeks ago

Thousand Oaks, United States Aditi Consulting Full time
Responsibilities:
  • Write or lead all aspects of the writing of clinical study reports and Investigator Brochures for products in all phases of clinical development (phases 1-4)
  • Write CTD sections including the Summary of Clinical Efficacy, Summary of Clinical Safety, Summary of Clinical Pharmacology, Summary of Biopharmaceutics, Clinical Overview, Table of All Studies, briefing documents, and safety narratives
  • Write other regulatory submission documents (eg, RTQs, PIPs, white papers, breakthrough therapy applications, orphan drug applications)
  • Lead study timelines for regulatory documents and regulatory submission strategy
  • Act as a functional area representative and lead on product teams
  • Assist with the following activities: hiring, resourcing therapeutic areas and project teams, and departmental governance
  • Ensure quality of regulatory submission documents at all stages of development

Must Have Skill Sets:
  • Masters or higher degree in biology, chemistry, or other scientific field
  • 5+ years in writing clinical and regulatory documents
  • Ability to optimally operate in an environment that involves negotiation, persuasion, collaboration, and analytical judgment
  • Ability to analyze medical data and interpret its significance
  • Sophisticated knowledge of scientific/technical writing and editing and of related regulatory guidance (eg, ICH) governing regulatory submission documents and industry compliance

Basic Qualifications:
Doctorate degree Or Master's degree and 3 years of Writing Regulatory or scientific submission/documents experience Or Bachelor's degree and 5 years of Writing Regulatory or scientific submission/documents experience Or Associate's degree and 10 years of Writing Regulatory or scientific submission/documents experience Or High school diploma / GED and 12 years of Writing Regulatory or scientific submission/documents experience

Preferred Qualifications:
  • Masters or higher degree in biology, chemistry, or other scientific field
  • 5+ years in writing clinical and regulatory documents
  • Ability to optimally operate in an environment that involves negotiation, persuasion, collaboration, and analytical judgment
  • Ability to analyze medical data and interpret its significance
  • Sophisticated knowledge of scientific/technical writing and editing and of related regulatory guidance (eg, ICH) governing regulatory submission documents and industry compliance
  • Strong written/oral communication skills and attention to detail


Compensation:
The pay rate range above is the base hourly pay range that Aditi Consulting reasonably expects to pay someone for this position (compensation may vary outside of this range depending on several factors, including but not limited to, a candidate's qualifications, skills, competencies, competencies, experience, location and end client requirements).

Benefits and Ancillaries:
Medical, dental, vision, PTO benefits and ancillaries may be available for eligible Aditi Consulting employees and vary based on the plan options selected by the employee.

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