Regulatory Writing Manager, Biopharmaceutics - Remote (JP12795)
Company: 3 Key Consulting
Location: Thousand Oaks
Posted on: April 3, 2026
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Job Description:
Job Title: Regulatory Writing Manager, Biopharmaceutics - Remote
(JP12795) Location: Thousand Oaks, CA. 91320 (REMOTE) Business
Unit: Global Regulatory Affairs Execution Team Employment Type:
Contract Duration: 6 months (with possible extensions) Rate : $46 -
$50 /hr. W2. Posting Date: 6/27/2024. Notes: Only qualified
candidates need apply. Fully remote. Approximately 30 hours per
week. 3 Key Consulting is hiring! We are recruiting an Regulatory
Writing Manager for a consulting engagement with our direct client,
a leading global biotechnology company. Job Description: In this
vital role you will prepare and coordinate the preparation of
regulatory submission documents that comply with global regulatory
standards. Day to day activities include: 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 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 cross-departmental initiatives Top Must Have Skill
Sets: Must have experience briefing documents with significant
clinical content/Module 2 clinical summary documents. Looking for
3-5 years of experience with these document types. 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
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 Why is the Position Open? Supplement additional
workload on team Interview Process: Phone screens and video
conference We invite qualified candidates to send your resume to
resumes@3keyconsulting.com . If you decide that you’re not
interested in pursuing this particular position, please feel free
to take a look at the other positions on our website
www.3keyconsulting.com/careers. You are also welcome to share this
opportunity with anyone you think might be interested in applying
for this role. Regards, 3KC Talent Acquisition Team
Keywords: 3 Key Consulting, Covina , Regulatory Writing Manager, Biopharmaceutics - Remote (JP12795), Science, Research & Development , Thousand Oaks, California
