Senior Strategic Medical Writer - Remote

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 through products and services in our Allergan Aesthetics portfolio.

Responsibilities

• Prepares clinical and regulatory documents needed for the development of AbbVie drugs and/or devices, functioning with a moderate degree of autonomy on draft materials while relying on review by subject matter experts and more senior writers for verification.
• Develops 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, ensuring 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.

Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8-hour day) is required.

Requirements

• 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.

Benefits

• Paid time off (vacation, holidays, sick).
• Medical, dental, and vision insurance.
• 401(k) retirement plan.
• Eligibility to participate in short-term incentive programs.