Senior Associate, Trial Disclosure

Company Description

About Abb Vie

Abb Vie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about Abb Vie, please visit us at  Follow @abbvie on Linked In,Facebook,Instagram,Xand You Tube .

The Senior Associate, Trial Disclosure will be responsible for providing writing support to clinical trial registration and results postings including scientific study results and or protocol/results lay summaries and meeting required deadlines. Also responsible for the planning and execution of clinical drug trial registrations per the applicable regulatory requirements. The Senior Associate, Trial Disclosure Associate will also support Agency Disclosure activities, company wide Redaction/Anonymization of clinical documents for public disclosure and Access To Data processes.

Responsibilities

• Completes writing activities to assist in ensuring 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 changes in regulatory requirements via participation in the development and implementation of Standard Operating Procedures (SOPs)/processes, creating efficiency improvements/system automation and communication and training activities.
• Communicates deliverables, writing process and timelines effectively across functional areas and within department to accomplish project objectives.
• Coordinates the review, approval, and other appropriate functions involved with the registration and writing of clinical trial results public postings and Agency Disclosure activities.
• Accountable for completing the assigned studies within established timelines and with an appropriate quality level. Held accountable for driving writing projects and registration activities to timely completion.
• Identifies conflicts and resolves or elevates them to management to ensure resolution.
• Provides writing support for unique registrations to global registries or websites, includes non-interventional safety studies
• Writes scientific study results and/or protocol/result lay summaries to registries and websites for multiple therapeutic areas with more complex study designs per global registry requirements
• Supports anonymization of Protected Personal Data (PPD) and redaction of Commercially Confidential Information (CCI) in clinical documents for submission to and public release by regulatory agencies.
  6. Supports company wide Redaction/Anonymization of clinical documents for public disclosure and Access To Data processes.

• Bachelor's degree (BA/BS) from an accredited college or university is required, preferably in a health or biological science field
• 3-4 years experience in clinical trial registries, regulatory agency transparency or drug development with a clinical research, quality or regulatory background.
• Relevant industry experience in medical writing in the healthcare industry or academia preferred;
  American Medical Writing Association (AMWA) certification or other is preferred, with a specialty in Editing/Writing or Pharmaceutical. 1-3 years of writing experience preferred.
• Knowledge of generally accepted project management practices. Demonstrated success in managing broad scope projects involving cross-functional teamwork.
• Excellent communication (written and verbal), organization, planning, execution, and team leadership skills are required.…