Principal Strategic Medical Writer - Specialty, Oncology, Immunology

Clinical And Regulatory Document Specialist

Responsible for leading and writing clinical and regulatory documents for drug and/or device development in support of company objectives.

Responsibilities:

Independently prepares most clinical and regulatory documents needed for the development of AbbVIe drugs and/or devices. Coordinates the review, approval, and quality control of other functions involved in the production of clinical and regulatory documents. Arranges and conducts review meetings with the team. Works closely with the team(s) on document authoring and content strategies. Communicates deliverables needed, writing process, and timelines to team members. Holds team members accountable to agreed-upon project dates. Contributes to project management strategies and develops ability to lead team members, driving submission objectives. Recommends, leads and/or participates in implementation/execution of tactical process improvements. Develops expert knowledge of US and international regulations, requirements, and guidance associated with preparation of regulatory documentation. Identifies and proposes solutions to resolve issues and questions arising during the writing process, including resolution or escalation as appropriate. Learns and applies therapeutic area and product knowledge to scientific projects and business improvement projects. Works independently with R&D Quality Assurance to address inquiries and draft responses, maintaining an inspection-ready approach.

Qualifications:

A minimum of 5+ years of bio-pharmaceutical industry experience in a 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. Extensive 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. 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 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.