Senior Associate, Trial Disclosure

Allergan; Northern (KY); Hybrid; 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

Company 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,XandYouTube.

Job Description

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.

Additional Information

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

• The compensation range described below is the range of possible base pay compensation that the Companybelieves ingood faith it will pay for this role at thetimeofthis posting based on the job grade for this position.Individualcompensation paid within this range will depend on many factors including geographiclocation,andwemayultimatelypaymore or less than the posted range. This range may bemodifiedin thefuture.


• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick),medical/dental/visioninsurance and 401(k) to eligibleemployees.


• This job is eligible toparticipatein our short-term incentiveprograms.

Note: No amount of payis considered to bewages or compensation until such amount is earned, vested, anddeterminable.Theamountandavailabilityof anybonus,commission, incentive, benefits, or any other form ofcompensation and benefitsthat are allocable to a particular employeeremainsin the Company'ssoleandabsolutediscretion unless and until paid andmay bemodifiedat the Company’s sole and absolute discretion, consistent withapplicable law.

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