Senior Manager, Regulatory Medical Writing in London

An opportunity to join a growing specialty pharmaceutical company that focuses on developing innovative treatments for hard-to-treat diseases, with key areas including immuno-oncology, gene therapy, mitochondrial biology, blindness and regeneration, and targeted protein degradation.

Acts as a Global Medical Writing Lead generally in mid‐to‐late‐stage development global project teams. The individual provides leadership with respect to all program documents and may act as the departmental expert on IND / IMPD dossier components, briefing documents, and responses to regulatory authorities across programs. The individual independently analyzes proposed program, study, and related documents for their ability to deliver the information required by the target audience (e.g., regulatory authority) with accuracy and consistency. The individual reviews documents within a therapeutic area with respect to consistency with the team / corporate established strategy and document history; ensures a consistent pattern of successful completion of assigned responsibilities within a program resulting in the production of high‐quality documents that meet corporate needs and global regulatory requirements; and provides intellectual leadership and contributes document knowledge and expertise to the global project team.

Responsibilities

• Acts as a primary lead for all assigned programs (generally mid‐to‐late‐stage development).
• As a document specialist, provides intellectual leadership and contributes document knowledge and expertise to the global project team.
• May act as the departmental expert on IND / IMPD dossier components, briefing documents, and responses to regulatory authorities across programs.
• Reviews documents within a therapeutic area with respect to consistency with the team / corporate established strategy and document history, ensuring a consistent pattern of successful completion of assigned responsibilities resulting in the production of high‐quality documents that meet corporate needs and global regulatory requirements.
• For all documents within a program, independently implements adjustments in specific document content within framework of provided templates in order to fit the needs of specific document / core team requirements.
• Participates in standards and processes initiatives / activities and other departmental project activities (up to a total of 15% of time).
• May participate in a multidiscipline productivity or process initiative.
• Supports Line Management in the improvement of departmental performance and outsourcing alliances through analysis and evaluation of metrics and performance data.

Required Qualifications

• BA / BS degree or equivalent, 10+ years relevant experience.
• Preferred: PhD / Pharm D or MS / MA / MPH with at least 10 years as a writing professional in pharmaceutical industry, with 2‐5 years' experience in managing / supervising activities associated with the creation of regulated documents in the pharmaceutical industry.
• Technical expert on all document types produced by medical writing.
• Demonstrated and substantial experience in leading / managing the creation of IND / IMPD and NDA / MAA components, briefing documents, responses to regulatory authorities. Preferred experience in preparing for advisory committees.
• Strong communication and leadership skills; strategic thinker.
• Please note this role is a senior role within the business, so you MUST have extensive experience in RA medical writing and have excellent communication skills.
• The role DOES NOT offer job sponsorship, so you must hold the full right to work in the UK and be based in the United Kingdom.