Sr Regulatory Writing Manager

Sr. Regulatory Writing Manager Remote
9month contract with potential extension.
US Citizenship or Permanent Resident is required.

Job Description
In this vital role you will prepare and coordinate the preparation of regulatory submission documents that comply with global regulatory standards.
Write or lead all aspects of the writing of clinical study reports and Investigator Brochures for products in all phases of clinical development (phases 14)
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
Provide expertise and mentorship on document design and principles of good medical writing to the department and product teams
Participate in departmental meetings as well as departmental and crossdepartmental initiatives

Basic Qualifications:
Doctorate degree Or
Masters degree and 3 years of Writing Regulatory or scientific submission/documents experience Or
Bachelors degree and 5 years of Writing Regulatory or scientific submission/documents experience Or
Associates 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 (e.g. ICH) governing regulatory submission documents and industry compliance
Strong written/oral communication skills and attention to detail
Understanding and application of principles concepts theories and standards of scientific/technical field
Strong time and project management skills engaging approach and perseverance with a drive for results
Leadership skills and ability to guide and influence the work of others
Strong leadership in a collaborative team environment

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