Principal Medical Writer

Principal Medical Writer

The Principal Medical Writer is an individual expert contributor capable of independently executing complex writing assignments involving a thorough understanding of clinical trial designs and interpretation of statistically analyzed research data. He/she would be expected to drive and coordinate the process to draft, review and approve written assignments including marketing application submission documents. He/she has the ability to plan and prioritize without supervision. This role requires extensive clinical document expertise and will support continuous improvement and the implementation of best practices.

Specifically for this position:

• 7+ years of advanced regulatory medical writing experience (protocol, CSRs, briefing books, summary modules), prior experience in oncology and understanding of clinical pharmacology concepts will be an advantage.
• Advanced understanding of and ability to apply statistical and regulatory concepts needed to independently write complex regulatory documents without the guidance of a supervisor.
• Proven expertise in completion of a multiple-document projects including functioning as the lead medical writer (e.g. Lead Writer for a CTD submission dossier with authoring and oversight activities across several Module 2 documents).

Key Responsibilities include, but are not limited to:

• Proven track record in writing clinical regulatory documents including, but not limited to: protocols, clinical study reports, NDA/MAA CTD submission documents, investigator brochures, briefing documents, and responses to regulatory authority questions.
• Work in a matrix team to ensure delivery of high quality, fit-for-purpose clinical documents that accurately reflect associated data, and are in line with GSK standards and global, regional and/or local regulatory requirements.
• Experienced as a significant contributor in planning and production of clinical dossier documents for regulatory submissions worldwide.
• Demonstrated effectiveness in management of projects of increasing scope and complexity.
• Understanding of the interdependencies of various contributing functions (e.g., clinical pharmacology, biomarkers, health outcome).
• Ability to quickly assess complex situations, apply scientific, operational, and submission development knowledge and implement effective plans for solutions.
• High-level technical, statistical, and computer skills, and the ability to interpret complex clinical data.
• Assess trends and patterns in text and statistical data, and effectively organizes content and messages in clinical reports and summary documents.
• Review reporting and analysis plans and provides critical input on the content and display of tables.
• Familiarity with approaches to expedite document preparation such as review tools and automation.
• Demonstrated ability and willingness to adjust behaviors and priorities based on a changing environment (e.g., ability to support documents in different therapeutic areas).
• Effectiveness in both oral and written communications.

Required Qualifications:

• PhD or relevant working experience within the life sciences space.
• Clinical regulatory writing experience in the pharmaceutical industry.
• Demonstration of leadership.
• Experience in multicultural settings (to reflect our external customers/clients [health authorities/patients] and diverse environments with respect to dynamics of human interaction (including working with remote teams).
• Ability to interpret, describe and document clinical data.
• Working knowledge of International Committee for Harmonisation (ICH)/Good Clinical Practice (GCP).
• Computer skills and general computer literacy.
• Excellent English language skills (verbal and written).