AbbVie

Senior Associate, Quality Control

AbbVie • $88K — $105K *
Chicago, IL 60629In-Person
Pharmaceuticals & Biotech
Less than 5 years of experience
Today
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Job Overview by Ladders

Qualifications

  • Bachelor's degree required, preferably in Science, English, or Communication.
  • 3-4 years of relevant industry experience in quality control or related fields.
  • Project management experience preferred.
  • Excellent understanding of clinical document organization and eCTD structure.
  • Knowledgeable about global regulatory requirements and scientific publication processes.
  • Proven analytical, critical thinking, and communication abilities.
  • Experience collaborating within cross-functional teams.

Responsibilities

  • Defines and conducts quality control activities for clinical documents.
  • Ensures completeness and accuracy of quality control documentation in the master file.
  • Maintains knowledge of clinical regulatory document requirements.
  • Mentors junior staff and oversees contractors as needed.
  • Leads development and maintenance of medical writing operations processes.
  • Manages outsourced quality control vendors including training and documentation preparation.
  • Communicates quality control deliverables to stakeholders clearly and effectively.

Benefits

  • Comprehensive benefits package including paid time off, medical/dental/vision insurance, and 401(k).
  • Eligibility for participation in short-term incentive programs.
Full Job Description
Job Description

Purpose:

The Strategic Medical Writing Operations Team is dedicated to delivering high-quality, scientifically accurate, and strategically aligned clinical and regulatory documentation that supports AbbVie's mission to transform the standard of care. Our team serves as a critical link between research, development, and regulatory submissions, ensuring clarity and compliance in all clinical and regulatory documents. We strive to innovate and enhance the processes of medical writing through cross-functional collaboration, agile methodologies, and the integration of cutting-edge technology, driving forward AbbVie's commitment to improving patient outcomes worldwide.

Responsibilities:
  • Defines scope of quality control activities with the document author and the required source documents and data required. Conducts independent quality control review of documents per applicable checklist by checking against source documents to ensure results are accurate.
  • Ensures quality control documentation is complete and accurate and uploaded to the master file per the established business processes.
  • Maintain strong knowledge of clinical regulatory documents requiring quality control review and business processes.
  • Mentors and provides guidance and training to less senior medical writing operations staff members. Provides management and oversight/supervision of 2 or more contractors as delegated.
  • Leads the development, implementation, and maintenance of medical writing operations business processes. Acts as subject matter expert (SME) for the master file system and quality control to the medical writing stakeholders.
  • Manages quality control outsourced to vendors that includes providing training and the preparation of the required documentation (e.g. clinical documents, checklists) for the quality control.
  • Effectively communicates quality control deliverables needed to stakeholders. Must demonstrate good interpersonal and organizational communication skills, including conflict management skills.


Qualifications

  • Bachelor's degree required. Bachelor's degree in Science, English, or Communication preferred.
  • 3-4 years in relevant industry experience in quality control/review of clinical regulatory documents or related experience in an area such as quality assurance, clinical research, drug development, medical writing, regulatory, or product support/R&D. Note: Higher education may compensate for years of experience. Years of experience may also compensate for lower education.
  • Project management experience is preferred.
  • Excellent knowledge of organization and content of clinical documents and eCTD structure. Knowledge of drug development and experience with Common Technical Document (CTD) content templates.
  • Working knowledge of global regulatory requirements and guidance associated with scientific publications or clinical regulatory document preparation and submissions. Competent/expertise in the application of business processes (guidelines, standard operating procedures, work instructions, job aids, etc).
  • Experience in being flexible with changing workload that requires prioritization and planning to support immediate/urgent business needs. Operations with limited oversight. Proven analytical and critical thinking skills.
  • Demonstrate higher degree of oral/written communication, interpersonal/organizational, analytical/critical thinking, and conflict management skills. Superior attention to detail and ability to prioritize multiple tasks/projects.
  • Experience in working with collaborative cross functional teams.
  • Demonstrate higher degree of proficiency, skill, and knowledge then more junior level. Computer literacy (hardware and software)/technical skills (ability to apply towards process improvements/operational efficiencies/automation).
  • Proficient skill and knowledge in Microsoft Office Products (Excel, OneNote, Outlook, PowerPoint, Project, SharePoint, Visio, Word) and Adobe in Windows operating system environment required. Proficient skills and knowledge in Microsoft document file formats (DocX) or other style file format tools, publishing software, and content management archival system(s) for eTMF/eSubmissions (Veeva Vault, CARA).


Additional Information

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

About AbbVie

AbbVie develops pharmaceuticals and medical devices. They provide products and services to therapeutic areas including immunology, oncology, neuroscience, eye care, virology, women's health, and gastroenterology.

AbbVie Careers

Joining AbbVie means becoming part of a global team dedicated to making a remarkable impact on patients' lives. At AbbVie, our employees are united in the pursuit of groundbreaking innovation and are committed to transforming the future of healthcare with leading-edge science.

Work You’ll Do

At AbbVie, you’ll collaborate with some of the brightest minds in the industry to solve challenging problems that have a high impact on society. Our culture fosters growth and embraces leadership and diversity training, ensuring that every team member can thrive.

Explore Job Opportunities

AbbVie offers a wide range of job opportunities and career paths, providing a platform where professionals can propel their careers forward. From research and development to marketing and sales, the potential to make a significant impact is limitless.

Internship Programs

Kickstart your career with an AbbVie internship. Our programs provide invaluable industry experience and a chance to develop essential skills in a real-world setting. Interns at AbbVie are considered integral members of the team and are given tasks that are both challenging and rewarding.

Professional Growth and Development

We believe in nurturing our team's professional growth through comprehensive training programs, leadership development opportunities, and continuous learning. Our commitment to your career growth is reflected in our robust offerings that enhance your skills and knowledge.

Benefits and Culture

AbbVie is dedicated to supporting our employees' well-being both inside and outside of work. Our benefits package includes health, financial, and social benefits that are designed to support the diverse needs of our employees. Our inclusive culture encourages collaboration and innovation, fostering a workplace where all can excel.

Hiring Process

Our hiring process is designed to ensure a match that will be beneficial both for the company and for your career aspirations. From resume submission to interview, each step is an opportunity to showcase your skills and fit with the AbbVie team.

Networking and Career Advancement

At AbbVie, networking doesn’t just enhance your career; it propels it. We encourage our employees to engage internally and externally to build relationships that foster personal and professional growth.

Join Our Team

Search open positions that match your skills and interests. We are looking for passionate, curious, and innovative team players who are ready to make a difference.

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Explore AbbVie Jobs

Whether you’re seeking to advance your career in a dynamic and empowering environment, or looking for a place where you can innovate, lead, and contribute to something bigger, AbbVie is the place for you. Join us in our mission to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow.
Learn more about AbbVie
Size
50,000 employees
Market Cap
$288.5 billion
Industry
Pharmaceuticals & Biotech
Net Income
$4.6 billion
Founded
2013
5 Year Trend
+17%
Revenue
$45.8 billion
NASDAQ
ABBV
* Ladders Estimates

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