AbbVie

Senior Strategic Medical Writer - Remote

AbbVie • $100K — $130K *
US-AnywhereRemote in Chicago, IL
Pharmaceuticals & Biotech
Less than 5 years of experience
Today
Be an Early Applicant
Job Overview by Ladders

Qualifications

  • 4+ years of experience in the bio-pharmaceutical industry.
  • Bachelor's Degree or higher in a scientific discipline preferred.
  • Exceptional written and oral communication skills, especially in medical terminology.
  • Experience writing clinical and regulatory documents per ICH guidelines and GCP.
  • Understanding of drug development, clinical research, and regulatory requirements across various therapeutic areas.
  • Familiar with study designs, biostatistics, and pharmacology concepts.
  • Strong organizational skills and ability to manage multiple projects.

Responsibilities

  • Prepares clinical and regulatory documents for drug and device development.
  • Works autonomously on draft materials while seeking expert review for verification.
  • Coordinates review and approval processes across involved teams.
  • Ensures quality and compliance of all documents within project timelines.
  • Develops knowledge of regulations regarding regulatory documentation preparation.
  • Implements tactical process improvements as needed.
  • Proposes solutions to issues encountered during the writing process.

Benefits

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

The Senior Strategic Medical Writer is responsible for leading and writing clinical and regulatory documents for drug and/or device development in support of company objectives.

Responsibilities:
  • Prepares clinical and regulatory documents needed for the development of AbbVie drugs and/or devices.
  • Functions with a moderate degree of autonomy on draft materials, but relies on review by subject matter experts and more senior writers for verification. Develops knowledge and understanding of submission strategies.
  • Coordinates the review, approval, and quality control of other functions involved in the production of clinical and regulatory projects. Arranges and conducts review meetings with the team.
  • Produces and maintains clinical and regulatory documents focusing on quality and compliance and ensures delivery within project timelines. Develops understanding of project management concepts and accepts greater responsibility for driving submission objectives.
  • Develops knowledge of US and international regulations, requirements, and guidelines pertaining to the preparation of regulatory documentation. Understands and uses guidance associated with preparation of regulatory documentation.
  • Participates in execution of tactical process improvements.
  • Identifies and proposes solutions to resolve issues and questions arising during the writing process, including resolution or escalation as appropriate.
  • Works closely with leadership and R&D Quality Assurance to address inquiries and draft responses, supporting an inspection-ready approach.

Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hr day) is required

Qualifications
  • A minimum of 4+ years of bio-pharmaceutical industry experience in global pharma, biotech, life science, or healthcare authority delivering medicines/therapies to a broad market across various therapeutic areas.
  • Bachelor's Degree or higher required; scientific discipline preferred.
  • Outstanding written and oral communication skills, with a comprehensive knowledge of medical and scientific terminology across multiple therapeutic areas.
  • Proficient in assimilating and analyzing complex data.
  • Experience writing and editing clinical and regulatory documents following guidelines and regulations, such as ICH guidelines, GCP, and other regulatory requirements. Familiarity with industry standards like CONSORT and PRISMA guidelines. EU and US device writing experience is a plus.
  • Understanding of drug development, clinical research, study designs, biostatistics, pharmacology, regulatory requirements, and medical terminology across functional teams and multiple contributors
  • Excellent writing skills. Effectively communicates complex scientific and medical information to various stakeholders.
  • Ability to oversee multiple projects simultaneously and collaborate with cross-functional teams. Strong organizational, time management, and problem-solving skills.


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 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 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.

Stay Connected

Keep up to date with career tips, insider perspectives, and industry-leading insights you can put to use today—all from the people who work here.

Job Alert Emails

Personalize your subscription to receive job alerts, latest news, and insider tips tailored to your preferences. Discover the exciting and rewarding opportunities that await at AbbVie.

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

Similar Jobs

Ad banner background

Get Ready For Your
Next Interview

More Jobs at AbbVie

More Pharmaceuticals & Biotech Jobs

Find similar Senior Strategic Medical Writer - Remote jobs:

NationwideRemote