16 Regulatory Writing Manager (100% Remote) (JP12795) Jobs in Thousand Oaks, CA
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Regulatory Writing Manager (100% Remote) (JP12795)
$137k-181k (estimate)
Full Time | Business Services
2 Days Ago
3 Key Consulting is Hiring a Remote Regulatory Writing Manager (100% Remote) (JP12795)
Job Title: Regulatory Writing Manager (100% Remote) (JP12795)Location: Thousand Oaks, CA. 91320 (REMOTE)Business Unit: Global Regulatory Affairs Execution TeamEmployment Type: ContractDuration: 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
- 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
- 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
Job Summary
JOB TYPE
Full Time
INDUSTRY
Business Services
SALARY
$137k-181k (estimate)
POST DATE
06/29/2024
EXPIRATION DATE
08/28/2024
WEBSITE
3keyconsulting.com
HEADQUARTERS
WEST HILLS, CA
SIZE
100 - 200
FOUNDED
2009
TYPE
Private
REVENUE
$50M - $200M
INDUSTRY
Business Services
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