AbbVie

Principal Strategic Medical Writer

AbbVie • $120K — $145K *
Chicago, IL 60629In-Person
Pharmaceuticals & Biotech
5 - 7 years of experience
Today
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Job Overview by Ladders

Qualifications

  • 5+ years in biopharmaceutical industry, expertise in drug/device development across various therapeutic areas
  • Bachelor's Degree or higher, preferably in a scientific discipline
  • Exceptional written and oral communication skills with extensive medical and scientific knowledge
  • Proficient in analyzing complex datasets and writing clinical/regulatory documents
  • Strong understanding of drug development and regulatory requirements, including ICH and GCP
  • Expertise in overseeing projects and collaborating with cross-functional teams
  • Advanced organizational, time management, and problem-solving abilities

Responsibilities

  • Independently prepares clinical and regulatory documents for drug/device development
  • Coordinates review, approval, and quality control processes with team members
  • Communicates timelines and deliverables to project team
  • Ensures accountability for project dates among team members
  • Contributes to project management and leads team efforts towards submission goals
  • Implements process improvements to enhance document quality and efficiency
  • Develops strong knowledge of US and international regulatory guidelines
  • Identifies and addresses issues during the writing process
  • Collaborates with R&D Quality Assurance to maintain compliance and readiness for inspections

Benefits

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

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

Responsibilities:
  • Independently prepares most clinical and regulatory documents needed for the development of AbbVIe drugs and/or devices.
  • Coordinates the review, approval, and quality control of other functions involved in the production of clinical and regulatory documents. Arranges and conducts review meetings with the team. Works closely with the team(s) on document authoring and content strategies.
  • Communicates deliverables needed, writing process, and timelines to team members.
  • Holds team members accountable to agreed-upon project dates.
  • Contributes to project management strategies and develops ability to lead team members, driving submission objectives.
  • Recommends, leads and/or participates in implementation/execution of tactical process improvements.
  • Develops expert knowledge of US and international regulations, requirements, and guidance associated with preparation of regulatory documentation.
  • Identifies and proposes solutions to resolve issues and questions arising during the writing process, including resolution or escalation as appropriate.
  • Learns and applies therapeutic area and product knowledge to scientific projects and business improvement projects.
  • Works independently with R&D Quality Assurance to address inquiries and draft responses, maintaining an inspection-ready approach.


Qualifications
  • A minimum of 5+ years of bio-pharmaceutical industry experience in a 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.
  • Extensive 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.
  • Advanced 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 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

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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