ICONMA
Regulatory Writing Mgr
ICONMA, Newbury Park, California, us, 91319
Regulatory Writing Manager
Location: Thousand Oaks, CADuration: 6-7 months With possible Extension
Description:Day to Day Responsibilities: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 narrativesWrite other regulatory submission documents (eg, RTQs, PIPs, white papers, breakthrough therapy applications, orphan drug applications)Lead study timelines for regulatory documents and regulatory submission strategyAct as a functional area representative and lead on product teamsAssist with the following activities: hiring, resourcing therapeutic areas and project teams, and departmental governanceEnsure quality of regulatory submission documents at all stages of developmentProvide expertise and mentorship on document design and principles of good medical writing to the department and product teamsParticipate in departmental meetings, as well as departmental and cross-departmental initiatives
Basic Qualifications:Doctorate degreeOrMaster's degree and 3 years of Writing Regulatory or scientific submission/documents experienceOrBachelor's degree and 5 years of Writing Regulatory or scientific submission/documents experienceOrAssociate's degree and 10 years of Writing Regulatory or scientific submission/documents experienceOrHigh school diploma / GED and 12 years of Writing Regulatory or scientific submission/documents experience
Top 3 Must Have Skill Sets:/Preferred Qualifications: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 field5+ years in writing clinical and regulatory documentsAbility to optimally operate in an environment that involves negotiation, persuasion, collaboration, and analytical judgmentAbility to analyze medical data and interpret its significanceSophisticated knowledge of scientific/technical writing and editing and of related regulatory guidance (eg, ICH) governing regulatory submission documents and industry complianceStrong written/oral communication skills and attention to detailUnderstanding and application of principles, concepts, theories, and standards of scientific/technical fieldStrong time and project management skills, engaging approach, and perseverance with a drive for resultsLeadership skills and ability to guide and influence the work of othersStrong leadership in a collaborative team environment
As an equal opportunity employer, ICONMA provides an employment environment that supports and encourages the abilities of all persons without regard to race, color, religion, gender, sexual orientation, gender identity or express, ethnicity, national origin, age, disability status, political affiliation, genetics, marital status, protected veteran status, or any other characteristic protected by federal, state, or local laws.
Location: Thousand Oaks, CADuration: 6-7 months With possible Extension
Description:Day to Day Responsibilities: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 narrativesWrite other regulatory submission documents (eg, RTQs, PIPs, white papers, breakthrough therapy applications, orphan drug applications)Lead study timelines for regulatory documents and regulatory submission strategyAct as a functional area representative and lead on product teamsAssist with the following activities: hiring, resourcing therapeutic areas and project teams, and departmental governanceEnsure quality of regulatory submission documents at all stages of developmentProvide expertise and mentorship on document design and principles of good medical writing to the department and product teamsParticipate in departmental meetings, as well as departmental and cross-departmental initiatives
Basic Qualifications:Doctorate degreeOrMaster's degree and 3 years of Writing Regulatory or scientific submission/documents experienceOrBachelor's degree and 5 years of Writing Regulatory or scientific submission/documents experienceOrAssociate's degree and 10 years of Writing Regulatory or scientific submission/documents experienceOrHigh school diploma / GED and 12 years of Writing Regulatory or scientific submission/documents experience
Top 3 Must Have Skill Sets:/Preferred Qualifications: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 field5+ years in writing clinical and regulatory documentsAbility to optimally operate in an environment that involves negotiation, persuasion, collaboration, and analytical judgmentAbility to analyze medical data and interpret its significanceSophisticated knowledge of scientific/technical writing and editing and of related regulatory guidance (eg, ICH) governing regulatory submission documents and industry complianceStrong written/oral communication skills and attention to detailUnderstanding and application of principles, concepts, theories, and standards of scientific/technical fieldStrong time and project management skills, engaging approach, and perseverance with a drive for resultsLeadership skills and ability to guide and influence the work of othersStrong leadership in a collaborative team environment
As an equal opportunity employer, ICONMA provides an employment environment that supports and encourages the abilities of all persons without regard to race, color, religion, gender, sexual orientation, gender identity or express, ethnicity, national origin, age, disability status, political affiliation, genetics, marital status, protected veteran status, or any other characteristic protected by federal, state, or local laws.