Aditi Consulting
Regulatory Writing Manager
Aditi Consulting, Thousand Oaks, California, United States, 91362
Summary:In this vital role you will prepare and coordinate the preparation of regulatory submission documents that comply with global regulatory standards.
Responsibilities:
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 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 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
Top Must Have Skill Set:
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
Compensation:The pay rate range above is the base hourly pay range that Aditi Consulting reasonably expects to pay someone for this position (compensation may vary outside of this range depending on a number of factors, including but not limited to, a candidate's qualifications, skills, competencies, experience, location and end client requirements).
Benefits and Ancillaries:Medical, dental, vision, PTO benefits and ancillaries may be available for eligible Aditi Consulting employees and vary based on the plan options selected by the employee.
Aditi Consulting LLC uses AI technology to engage candidates during the sourcing process. AI technology is used to gather data only and does not replace human-based decision making in employment decisions.
Responsibilities:
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 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 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
Top Must Have Skill Set:
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
Compensation:The pay rate range above is the base hourly pay range that Aditi Consulting reasonably expects to pay someone for this position (compensation may vary outside of this range depending on a number of factors, including but not limited to, a candidate's qualifications, skills, competencies, experience, location and end client requirements).
Benefits and Ancillaries:Medical, dental, vision, PTO benefits and ancillaries may be available for eligible Aditi Consulting employees and vary based on the plan options selected by the employee.
Aditi Consulting LLC uses AI technology to engage candidates during the sourcing process. AI technology is used to gather data only and does not replace human-based decision making in employment decisions.