Senior Strategic Medical Writer - Remote

AbbVie; North Chicago (IL); On-site; USD 120,000 - 190,000; Full time

Job summary

AbbVie is seeking a Senior Strategic Medical Writer to lead and author clinical and regulatory documents for drug and device development, supporting company objectives.

The role requires strong expertise in medical writing across therapeutic areas, regulatory guidelines (ICH, GCP), and a demonstrated ability to manage multiple projects with cross-functional teams.

Applicants should have excellent writing and communication skills and a track record of delivering submission-ready documents on time.

Qualifications

• 4+ years in bio-pharmaceutical industry delivering medicines across therapeutic areas.
• Outstanding written and oral communication with medical terminology knowledge.
• Experience writing clinical and regulatory documents per ICH, GCP, CONSORT/PRISMA guidelines.

Responsibilities

• Prepares clinical and regulatory documents for drug and/or device development.
• Autonomously drafts materials while coordinating reviews with SMEs and senior writers.
• Manages review meetings and ensures quality control and timely delivery of documents.
• Develops knowledge of submission strategies and regulatory requirements.
• Collaborates with leadership and QA to address inquiries for inspection readiness.

Skills

Bio-pharma experience

Excellent communication

Regulatory writing

Project management

Education

Bachelor's degree

Job 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 at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.

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 at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.

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. Develop 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