Senior Strategic Medical Writer
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Job Description
Senior Strategic Medical Writer leading clinical and regulatory documentation for AbbVie’s drug and device development. Coordinating reviews, quality control, submission strategies, and inspection-ready responses.
Responsibilities:
- Lead and write clinical and regulatory documents for drug and/or device development in support of company objectives
- Prepare clinical and regulatory documents needed for AbbVie drug and/or device development
- Draft materials with moderate autonomy and incorporate review by subject matter experts and senior writers
- Develop knowledge and understanding of submission strategies
- Coordinate review, approval, and quality control across functions involved in clinical and regulatory projects
- Arrange and conduct team review meetings
- Produce and maintain high-quality, compliant clinical and regulatory documents within project timelines
- Develop project management knowledge and take greater responsibility for driving submission objectives
- Apply US and international regulations, requirements, and guidelines to regulatory documentation
- Participate in tactical process improvements
- Identify and propose solutions to issues arising during the writing process, resolving or escalating as appropriate
- Work with leadership and R&D Quality Assurance to address inquiries and draft responses in support of an inspection-ready approach
Requirements:
- 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
- Comprehensive knowledge of medical and scientific terminology across multiple therapeutic areas
- Proficiency 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 CONSORT and PRISMA guidelines
- Understanding of drug development, clinical research, study designs, biostatistics, pharmacology, regulatory requirements, and medical terminology
- EU and US device writing experience is a plus
- Excellent writing skills
- Ability to communicate 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
- Ability to sit continuously for prolonged periods, more than 2 consecutive hours in an 8-hour day
Benefits:
- Paid time off, including vacation, holidays, and sick leave
- Medical, dental, and vision insurance
- 401(k)
- Eligibility to participate in long-term incentive programs
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