AbbVie

Principal Medical Writer

AbbVie • $100K — $130K *
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 in English, Communications or Life Science; Advanced degree/credentials preferred.
  • 3-4 years in medical writing or related fields like regulatory or clinical research.
  • Preferred AMWA certification with a focus on Editing/Writing or Pharmaceutical.
  • Extensive content writing experience, specifically for clinical publications or regulatory documents.
  • Expert-level understanding of US and international regulations for document preparation and compliance requirements.
  • Strong written and oral communication skills with a keen eye for detail and accuracy.
  • Proficient in word processing, flow diagrams, and spreadsheet software.

Responsibilities

  • Leads writing for complex scientific publications and regulatory documents.
  • Represents the writing department on project teams, acting as a subject matter expert.
  • Converts data into compliant forms for regulatory documents, coordinating review processes.
  • Maintains knowledge of relevant regulations and advises on compliance for publications.
  • Applies knowledge of therapeutic areas for scientific publishing projects and stays updated on industry requirements.
  • Facilitates effective team communication on project deliverables and timelines.
  • Interprets and explains research data, resolving document content issues independently.

Benefits

  • Paid time off including vacation, holidays, and sick leave.
  • Comprehensive medical, dental, and vision insurance.
  • 401(k) plan for eligible employees.
  • Participation in long-term incentive programs.
Full Job Description
Job Description

The Principal Medical Writer is responsible for providing scientific publications or clinical regulatory document support and advanced scientific writing expertise to the clinical teams, ensuring successful preparation of high quality submission-ready documents and effective implementation of the writing process. The Prinicipal Medical Writer provides medical writing expertise for multiple compounds and/or projects within a therapeutic area. Interfaces with external groups (e.g. PK, Toxicology, eSubmissions, Regulatory, Statistical Support, Data Management, Clinical, Publishing) to ensure accurate and timely completion/delivery of information and review of scientific publications or clinical regulatory submissions. The Prinicipal Medical Writer serves as a scientific writing content expert for the department and actively contributes to process improvement activities.

Responsibilities:
  • Serves as medical writing lead on more complex scientific publications or clinical regulatory documents such as those associated with filings and dossiers. Implements all activities related to the preparation of scientific publications (e.g. abstracts, posters/oral presentations, manuscripts) or to the preparation and compilation of data and information into a single comprehensive package for new and updated clinical regulatory documents.
  • Serves as a department representative on project teams. Serves as a subject matter expert within department for assigned therapeutic/product areas. Acts as Subject Matter Expert for assigned clinical teams regarding computer-based technologies utilized by the respective departments (e.g. COSMOS, eCTD, journal/congress databases). May mentor and provide guidance to more junior medical writers. Implements tactical process improvements.
  • Converts relevant data and information into a form that meets clinical regulatory document requirements. Explains data in manner consistent with the target audience(s), journal/congress requirements, and/or clinical regulatory requirements. Coordinates the review, approval, and other appropriate functions involved in the production of scientific publishing or clinical regulatory projects. Arranges and conducts review meetings with the team. Ensures required documentation is completed.
  • Maintains expert knowledge of US and international regulations, requirements and guidance associated with scientific publications or clinical regulatory document preparation and submissions. Advises teams regarding compliance with scientific publications or clinical regulatory document content as defined in journal/congress guidelines or regulations, respectively.
  • Learns and applies knowledge of therapeutic area and product to scientific publishing projects. Must continually train/be compliant with all current industry requirements as they relate to scientific publications or clinical regulatory submissions, including electronic submission/approval standards.
  • Responsible for effective communication to team members. Communicates deliverables needed, writing process, and timelines to team members. Holds team members accountable to agreed-upon project dates. Negotiates with functional areas on project outcomes and deliverables to meet conflicting demands (time, deliverables, etc.). Identify and resolve conflicts (including document content issues), remove barriers, generate innovative ways to ensure teams achieve project goals.
  • Understands, assimilates, and interprets sources of info Interprets and explains data generated from a variety of sources, including internal/external studies, research documentation, charts, graphs, and tables. Confirms completeness of info to be presented. Challenges conclusions when necessary. Independently resolves document content issues and questions.
  • Understands/complies with appropriate conventions, proper grammar usage, and correct format requirements per journal/congress, ICH and other governing bodies following applicable divisional guidelines, templates, and SOPs.
  • Arranges and conducts review meetings with the team. Acts as interface to resolve issues and questions arising during the writing process. Works with Regulatory Quality Assurance throughout clinical regulatory document audit process, answers questions during the audit process (as appropriate), and works with team to draft responses as necessary.
  • Recommends and implements tactical process improvements. Participates in process improvement activities.


Qualifications
  • Bachelor's degree in English or Communications with relevant science expertise or Bachelor's degree in Life Science with relevant writing expertise. Advanced degree and/or professional certification/credentials preferred.
  • 3-4 years relevant industry experience in medical writing in the healthcare industry or academia required or in a related area such as quality, regulatory, clinical research, or product support/R&D.
  • American Medical Writing Association (AMWA) certification or other is preferred, with a specialty in Editing/Writing or Pharmaceutical.
  • High-level content writing experience and experience with all types of clinical publications or clinical regulatory documents required. Expert in assimilation and interpretation of scientific content with adeptness in ability to translate for appropriate audience. Working knowledge of statistical concepts and techniques.
  • Expert knowledge of US and international regulations, requirements and guidance associated with scientific publications or clinical regulatory document preparation and submissions and ability to advise teams regarding compliance with regulations. Knowledge and expertise with Common Technical Document content templates. Expert knowledge of current electronic document management systems and information technology.
  • Excellent written and oral communication skills. Superior attention to detail. Ability to find and correct errors in spelling, punctuation, grammar, consistency, clarity and accuracy. Experience in working with collaborative, cross-functional teams, including project management experience.
  • Expert in word processing, flow diagrams, and spreadsheets. Excellent working knowledge of software programs in Windows environment.


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 thisposting 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 long-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 anduntil 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

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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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