Principal Strategic Medical Writer

AbbVie; Chicago (IL); On-site; USD 110,000 - 209,000; Full time

Benefits offered by this job

Health insurance

401(k) plan

Paid time off

Job summary

AbbVie is seeking a Principal Medical Writer to lead and write clinical and regulatory documents for drug and device development. You will work with cross-functional teams to develop content, ensure quality, and support submission objectives.

The role requires strong writing skills, regulatory knowledge, and the ability to manage multiple projects in a fast-paced environment across US and international guidelines.

Qualifications

• Proven ability to write and edit clinical/regulatory documents.
• Strong comprehension of medical terminology and regulatory guidelines.
• Experience with complex data and study designs.

Responsibilities

• Independently prepares clinical and regulatory documents for drug/device development.
• Coordinates review, approval, and quality control with cross-functional teams.
• Leads timelines, communicates deliverables, and ensures submission objectives.

Skills

Medical writing

Regulatory writing

ICH guidelines

Cross-functional collaboration

Scientific terminology

Education

Bachelor's degree

Job description

• Compensation: USD 109500 - USD 208500 - yearly

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 atwww.abbvie.com . Follow @abbvie onLinkedIn, Facebook ,Instagram ,X andYouTube.

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 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 the timeof thisposting based on the job grade for this position.Individualcompensation paid within this range will depend on many factors including geographic location,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 long-term incentiveprograms.

Note: No amount of payis considered to bewages or compensation until such amount is earned, vested, anddeterminable.The amount and availability of any bonus,commission,incentive, benefits, or any other form ofcompensation and benefitsthat are allocable to a particular employeeremainsin the Company's sole andabsolutediscretion unless anduntil 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 applicants seeking a reasonable accommodation, click here to learn more: