Senior Associate, Trial Disclosure

AbbVie Inc.; North Chicago (IL); On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Paid time off

Health insurance

Dental insurance

Vision insurance

401(k)

Job summary

AbbVie Inc. is seeking a Senior Associate, Trial Disclosure to support clinical trial registrations and results postings. You will write scientific results and lay summaries, ensuring timely and accurate public disclosures according to regulatory requirements.

The role involves planning registration activities, SOP implementation, and collaboration across departments to meet deadlines with high-quality output. Experience in medical writing and regulatory transparency is essential.

Qualifications

• Bachelor's degree in health or biological science required.
• 3-4 years experience in clinical trial registries, regulatory transparency or drug development.
• AMWA certification preferred; with editing/writing specialty.
• Strong project management and cross-functional teamwork skills.
• Excellent written and verbal communication.

Responsibilities

• Complete writing activities to ensure timely disclosure of accurate information globally.
• Provide medical writing expertise for multiple compounds/projects.
• Implement SOPs/process improvements and training activities.
• Communicate deliverables and timelines across teams.
• Coordinate review and approval for trial results postings and agency disclosure.

Skills

Bachelor's degree

3-4 years experience

AMWA certification

Editing/Writing

Project management

Cross-functional teamwork

Excellent communication

Education

Bachelor's degree in health or biological science

Tools

Excel

Word

Job description

About AbbVie AbbVie'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 AbbVie, please visit us at www.abbvie.com . Follow @abbvie on LinkedIn, Facebook , Instagram , X and YouTube.

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.

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

Qualifications

• 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. 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.

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:

Compensation

The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.

Benefits

• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
• This job is eligible to participate in our short-term incentive programs.

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.

Equal Opportunity Statement

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: https://www.abbvie.com/join-us/reasonable-accommodations.html