Senior Clinical Trial Disclosure Writer

Allergan; Northern (KY); On-site; USD 85,000 - 120,000; Full time

Job summary

AbbVie in the United States seeks a Senior Associate, Trial Disclosure to provide writing support for clinical trial registrations and results postings, including lay summaries, and to help plan and execute disclosures in compliance with regulatory requirements.

You will collaborate with cross-functional teams across clinical, regulatory, and safety groups, ensure timely delivery, and contribute to efficient SOPs and data redaction processes for public disclosures.

Qualifications

• Bachelor's degree required in health or biological sciences.
• 3–4 years experience in clinical trial registries, regulatory transparency, or drug development with a clinical research, quality or regulatory background.
• AMWA certification or equivalent preferred; editing/writing specialty; 1–3 years writing experience preferred.
• Knowledge of generally accepted project management practices and ability to manage cross-functional projects.
• Excellent written and verbal communication and ability to lead teams.
• Experience operating in an international environment and working across geographic locations.
• Familiarity with registration/results/lay summaries and agency disclosure requirements.

Responsibilities

• Completes writing activities to ensure timely disclosure of accurate, consistent, aligned and complete information globally.
• Provides medical writing expertise for multiple compounds and/or projects within a therapeutic area.
• Operationalizes regulatory changes via SOPs/processes, driving efficiency and training.
• Communicates deliverables, writing process and timelines across functions to accomplish project objectives.
• Coordinates the review, approval, and other functions involved with registration and public postings and agency disclosure activities.
• Drives writing projects and registration activities to timely completion.
• Identifies conflicts and escalates to management for resolution.
• Provides writing support for registrations to global registries/websites and safety studies.
• Writes study results and lay summaries for registries/websites per global requirements.
• Supports anonymization/redaction in regulatory submissions and public disclosures.

Skills

Medical writing

Regulatory knowledge

Project management

Communication skills

Cross-functional collaboration

Education

Bachelor’s degree in health or biological sciences

Tools

Excel

Word

Job description

AbbVie in the United States seeks a Senior Associate, Trial Disclosure to provide writing support for clinical trial registrations and results postings, including lay summaries, and to help plan and execute disclosures in compliance with regulatory requirements.

You will collaborate with cross-functional teams across clinical, regulatory, and safety groups, ensure timely delivery, and contribute to efficient SOPs and data redaction processes for public disclosures.