Principal Strategic Medical Writer

Summary

Join AbbVie's Strategic Medical Writing team as a Principal Strategic Medical Writer and lead the creation of clinical and regulatory documents. You will independently write most documents, coordinate reviews, conduct team meetings, and collaborate on content strategies. Responsibilities include communicating project timelines, holding team members accountable, contributing to project management, and recommending process improvements. You will develop expert regulatory knowledge and resolve issues during the writing process. The role requires a Bachelor's degree, 5+ years of biopharmaceutical experience, and excellent written and oral communication skills. AbbVie offers a comprehensive benefits package including paid time off, medical/dental/vision insurance, and 401(k).

Requirements

• Hold a Bachelor's Degree or higher in a scientific discipline
• Have a minimum of 5+ years of bio-pharmaceutical industry experience in a global pharma, biotech, life science, federal agency organization delivering medicines/therapies to a broad market across various therapeutic areas
• Demonstrate outstanding written and oral communication skills, with a comprehensive knowledge of medical and scientific terminology across multiple therapeutic areas
• Demonstrate excellent writing skills, effectively communicate and influence complex scientific and medical information to various stakeholders
• Demonstrate extensive experience writing, editing clinical documents following guidelines and regulations, such as ICH guidelines, GCP, and other regulatory requirements
• Demonstrate familiarity with industry standards like CONSORT and PRISMA guidelines
• Demonstrate proficiency in assimilating and analyzing complex data
• Demonstrate advanced understanding of drug development, clinical research, study designs, biostatistics, pharmacology, regulatory requirements, and medical terminology across functional teams and multiple contributors
• Demonstrate ability to oversee multiple projects simultaneously and collaborate with cross-functional teams
• Demonstrate strong organizational, time management, and problem-solving skills

Responsibilities

• Independently write most clinical and regulatory documents within remit
• Coordinate the review, approval, and quality control of other functions involved in the production of clinical and regulatory documents
• Arrange and conducts review meetings with the team
• Work closely with the team(s) on document authoring and content strategies
• Communicate deliverables needed, writing process, and timelines to team members
• Hold team members accountable to agreed-upon project dates
• Contribute to project management strategies and develops ability to lead team members, driving submission objectives
• Recommend, leads, and/or participate in implementation/execution of tactical process improvements
• Develop expert knowledge of US and international regulations, requirements, and guidance associated with preparation of regulatory documentation
• Identify and propose solutions to resolve issues and questions arising during the writing process, including resolution or escalation as appropriate
• Learn and apply therapeutic area and product knowledge to scientific projects and business improvement projects
• Work independently with R&D Quality Assurance to address inquiries and draft responses, maintaining an inspection-ready approach

Benefits

• Paid time off (vacation, holidays, sick)
• Medical/dental/vision insurance
• 401(k)
• Short-term incentive programs
• Long-term incentive programs