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Regulatory Writing Mgr
Thousand Oaks, CA
Job Description
FULLY REMOTE
Regulatory Writing Manager
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 initiatives
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
Ampcus is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identify, national origin, age, protected veterans or individuals with disabilities.
Regulatory Writing Manager
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 initiatives
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
Ampcus is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identify, national origin, age, protected veterans or individuals with disabilities.
Job Summary
Company
Start Date
As soon as possible
Employment Term and Type
Regular, Full Time
Required Education
High School or Equivalent
Required Experience
5+ years
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