Global Regulatory Writing – Senior Manager

Job Description:

Responsibilities

• 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
•  lead departmental and cross-departmental initiatives, as appropriate
• Generate document timeline and keep abreast of relevant professional information and technology

Qualification & Experience

• Doctorate degree and 2 years of directly related experience
• OR
• Master’s degree and 6 years of directly related experience