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This position has closed. AbbVie removed this listing from their careers page on Oct 6, 2026. The interview prep below is still useful, and there are similar open roles at the bottom of this page.

Principal Strategic Medical Writer

AbbVie · Chicago, IL · Remote available · Full time · Writing/Editing

Posted Aug 27, 2026 · We last checked this listing on Oct 5, 2026

Likely interview questions for this role

Written from this job description, not a generic list. Each one notes what the interviewer is really checking.

About your past

You'd coordinate review, approval and quality control across functions and hold team members accountable to agreed dates. How do you hold a senior reviewer to a deadline?

What they are checking: Whether they can hold senior reviewers to agreed dates respectfully, keeping submissions on schedule without formal authority over them.

You'd lead tactical process improvements. What would you change about how medical writing usually runs?

What they are checking: Whether they have thoughtful views about improving how medical writing works, showing they care about the craft beyond individual documents.

How do you develop a less experienced writer's judgment about what belongs in a document?

What they are checking: Whether they can develop junior writers' judgment about content, which is an important responsibility at the principal level.

What would you do

How do you keep a document accurate when the underlying analysis changes late?

What they are checking: Whether they manage late changes carefully so documents stay accurate and consistent, which is critical in regulatory submissions.

Two functions give conflicting comments on the same section. How do you resolve it?

What they are checking: Whether they can resolve conflicting reviewer comments diplomatically and clearly, the most common friction in medical writing.

There is a Senior Strategic Medical Writer role posted alongside this Principal one. Where do you place yourself, and what would you want to know about the programs before you took it?

What they are checking: Whether they can place themselves honestly between the two levels and would ask about the programs before committing.

About the work

This role independently prepares most clinical and regulatory documents for drug and device development. Which document types do you write without support?

What they are checking: Whether they can write the main clinical and regulatory documents independently, which is expected at the principal level.

You'd contribute to project management strategy and drive submission objectives. What does a writer contribute to a submission plan that a project manager cannot?

What they are checking: Whether they understand the strategic value a writer brings to submission planning, like message consistency across documents.

You'd develop expert knowledge of United States and international regulations for regulatory documentation. Which guidance shapes how you write, and where do writers most often get it wrong?

What they are checking: Whether they have deep knowledge of regulatory guidance for documents and can name common mistakes writers make.

What makes a clinical study report clear to a reviewer who has never seen the program?

What they are checking: Whether they write for the regulatory reviewer who reads the report fresh, making the story clear without prior program knowledge.

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The full job description

As published by AbbVie.

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. • 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. 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. 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 only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: https://www.abbvie.com/join-us/reasonable-accommodations.html