New · posted Oct 31
AbbVie · Pharmaceuticals
Principal Strategic Medical Writer
- Remote, US
- Remote
- Full-time
- Senior & Principal
The role
The Principal Strategic Medical Writer is responsible for leading and writing clinical and regulatory documents for drug and/or device development in support of company objectives.
What you need
What you'll do
- 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.
US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
Pay and benefits
$110,000 – $209,000 a year
Employer providedPaid time off
Medical/dental/vision insurance
401(k)
Long-term incentive programs
From the posting
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 at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.
Equal opportunity, accessibility and legal noticesAbbVie's statements, word for word
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:
Job intelligence
The context around this role
Live data · October 31, 2026
Salary intelligence
How the pay compares
This role's midpoint is 14% below the US median for Clinical Evaluation & Medical Writing roles at this level.
This roleEmployer provided
Senior & Principal roles in the US6 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $110,000 | — | $209,000 |
| All US (middle half) | $162,375 | $186,000 | $205,875 |
This role: AbbVie's own published range. Comparisons: the base pay employers published on open Clinical Evaluation & Medical Writing roles at the same level on Regulatory Jobs, October 31, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Clinical Evaluation & Medical Writing
The general path across 21 open Clinical Evaluation & Medical Writing roles on Regulatory Jobs, with the titles they carry most. Not AbbVie's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 25 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Collaboration and leadership9
- Documentation and SOPs8
- GMP and compliance3
- Regulatory submissions1
- Quality systems and risk1
- Clinical trial conduct1
Regulatory intelligence
The rules behind this role
Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.
Company hiring pulse
AbbVie on Regulatory Jobs
- 109
- Open roles
- 61
- Distinct roles
- 16
- Locations
By discipline
- Clinical60 55%
- Quality25 23%
- Regulatory24 22%
By level
- Director56 51%
- Manager24 22%
- Senior & Principal13 12%
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Principal Strategic Medical Writer at AbbVie
Open until filled. $110K–$209K a year, employer provided.