Regulatory Writing Mgr
Advanced Bio-Logic Solutions
- Thousand Oaks, CA
- $50.00 per hour
- Permanent
- Full-time
- 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
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 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 initiative
- 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
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 experiencePreferred 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