Principal Strategic Medical Writer - Device

Role Summary

Lead and write clinical and regulatory device and drug documents for regulatory submissions in the Aesthetics therapeutic area. Drive document authoring from study start-up to product approvals with a focus on quality, timelines, and cross-functional collaboration.

Responsibilities

• In Aesthetics we support drug and device documents globally. The writing team participates in writing documents from study start-up to those that support product approvals (e.g. briefing books, IND, protocol, CSR, NDA sections, and regulatory response as well as CER, IDE and PMA).
• 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 global regulations, requirements, and guidance associated with preparation of regulatory documentation.

Qualifications

• A minimum of 5+ years of bio-pharmaceutical industry experience in a global pharma, biotech, life science, medical aesthetics, federal agency organization delivering medicines/therapies to a broad market across various therapeutic areas.
• Bachelor's Degree or higher in a scientific discipline.
• Experience authoring device-specific documents preferred (e.g. CERs, SSCPs, IDEs, PMAs).
• 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, ISO, and other regulatory requirements. Familiarity with industry standards like CONSORT and PRISMA guidelines.
• Advanced understanding of drug and/or device development, clinical research, study designs, biostatistics, 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.