To prepare scientific and regulatory submission documents that comply with global regulatory standards.
Job Summary
To author and gain approval of scientific and regulatory submission documents that comply with global regulatory standards. To maintain key business relationships with appropriate cross-functional product team members. This role serves as functional area lead on product teams, leads writing activities for complex product submissions providing functional area expertise, trains and mentors more junior writers, and leads departmental activities.
Key Activities
Independently:
Author or oversee the authoring of all regulatory submission documents including Clinical Study Reports, Investigator Brochures, Responses to Questions, Protocols, Protocol Amendments, Informed Consent Forms, Table of All Studies, Clinical Overview Addenda, eCTD Module 2 Clinical Summary Documents, Briefing Documents, Pediatric Investigation Plans, and other regulatory documents;
Conduct the formal review and approval of authored documents, following applicable standard operating procedures;
With limited supervision, lead regulatory writing activities for complex product submissions, including new and supplemental drug applications/biologics license applications;
Serve as functional area lead on product teams (e.g., Global Regulatory Team, Evidence Generation Team, Global Safety Team, Label Working Group)
Provide functional area input for Global Regulatory Plan and team goals
oversee the work of contract and freelance writers train, mentor, or supervise more junior medical writers, as assigned
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lead departmental and cross-departmental initiatives, as appropriate
Generate document timeline and keep abreast of relevant professional information and technology
Knowledge and Skills
Required Knowledge and Skills:
Ability to independently analyze scientific data and interpret its significance in practical applications;
Excellent written/oral communication skills and attention to detail;
Highly skilled in word processing and other Microsoft Office programs
Expertise in scientific/technical writing and editing, and of overall clinical development process for new compounds;
Must demonstrate strong leadership skills in a team environment which requires negotiation, persuasion, collaboration, and analytical judgment;
Ability to understand, follow, and develop complex standard operating procedures (SOP’s), guidance documents, and work instructions;
Excellent time and project management skills
Self-starter with a drive and perseverance to achieve results and motivate others
Preferred Knowledge and Skills:
Deep understanding and application of principles, concepts, theories and standards of scientific/technical field.
Advanced knowledge of document management systems.
Expert knowledge and understanding of International Council on Harmonisation (ICH) and Good Clinical Practice (GCP) guidance's and requirements relevant to regulatory submissions.
Education & Experience (Basic)
Doctorate degree and 2 years of directly related experience
OR
Master’s degree and 6 years of directly related experience
OR
Bachelor’s degree and 8 years of directly related experience
OR
Associate’s degree and 10 years of directly related experience
OR
High school diploma / GED and 12 years of directly related experience
Education & Experience (Preferred)
Industry experience
12-17 years experience in writing clinical and regulatory documents for all phases of regulatory submissions (INDs to NDAs)
.
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