Senior Associate, Trial Disclosure

AbbVie•North Chicago, NJ

16h

About The Position

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, companywide Redaction/Anonymization of clinical documents for public disclosure and Access To Data processes.

Requirements

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.
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.
Relationship management, communication ability, influencing skills required.
Ability to successfully operate in an international environment and experience building effective working relationships across geographic locations.
Working knowledge of registration / results / lay summary / agency disclosure requirements.
Experienced in working in Excel, Word and other systems
Ability to assimilate and interpret scientific content and translate information for appropriate audience.
Superior attention to detail.
Ability to independently prioritize daily responsibilities and meet deadlines.
Strong working knowledge of global registration / results / lay summary / agency disclosure requirements.

Nice To Haves

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.

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.
Supports companywide Redaction/Anonymization of clinical documents for public disclosure and Access To Data processes.