Principal Strategic Medical Writer

Summary

Join AbbVie as a Principal Strategic Medical Writer and lead the creation of clinical and regulatory documents. You will independently write documents, coordinate reviews, and conduct meetings to ensure quality. Collaborate with cross-functional teams on document authoring and content strategies, communicating timelines and expectations. Contribute to project management, lead team members, and implement process improvements. Develop expert knowledge of US and international regulations and apply therapeutic area knowledge to projects. Address inquiries and maintain an inspection-ready approach.

Requirements

• 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
• Bachelor's Degree or higher in a scientific discipline
• 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, editing clinical documents following guidelines and regulations, such as ICH guidelines, GCP, and other regulatory requirements. Familiarity with industry standards like CONSORT and PRISMA guidelines
• 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 communicate and influence 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

Responsibilities

• Independently write most clinical and regulatory documents within their remit
• Coordinate the review, approval, and quality control processes involving other functions in the production of clinical and regulatory documents
• Arrange and conduct review meetings with the team to ensure thorough examination of content
• Work closely with teams on document authoring and content strategies to ensure alignment with project goals
• Communicate deliverables needed, the writing process, and timelines to team members, ensuring clarity and understanding of expectations
• Hold team members accountable to agreed-upon project dates, contributing to the success of timely submissions
• Contribute to project management strategies and develop the ability to lead team members, driving toward submission objectives
• Recommend, lead, and participate in the implementation and execution of tactical process improvements to enhance efficiency and effectiveness
• Develop expert knowledge of US and international regulations, requirements, and guidance associated with the preparation of regulatory documentation
• Identify and propose solutions to resolve issues and questions that arise during the writing process, including resolution or escalation as appropriate
• Learn and apply therapeutic area and product knowledge to scientific projects and business improvement initiatives
• 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