This is a fully remote position, open to applicants in United States.

📋 Description

• Act as the functional area leader within product teams.

• Direct writing tasks for intricate product submissions.

• Create or supervise regulatory submission documents, such as 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, and Pediatric Investigation Plans.

• Carry out formal reviews and approvals of authored documents in accordance with relevant standard operating procedures.

• Lead regulatory writing efforts for complex product submissions, including new and supplemental drug applications and biologics license applications.

• Function as the area leader on the Global Regulatory Team, Evidence Generation Team, Global Safety Team, and Label Working Group.

• Contribute functional area insights for the Global Regulatory Plan and team objectives.

• Manage contract and freelance writers while mentoring junior medical writers.

• Spearhead departmental and interdepartmental initiatives.

• Create and manage document timelines.

⛳️ Requirements

• Doctorate degree with 2 years of relevant experience OR Master’s degree with 6 years of relevant experience OR Bachelor’s degree with 8 years of relevant experience OR Associate’s degree with 10 years of relevant experience OR High school diploma/GED with 12 years of relevant experience.

• Proven experience with regulatory documents in Regulatory Affairs, Research, Development, or a related field.

• Over 5 years of experience in medical writing within the Biotech/Pharmaceutical industry.