Principal Medical Writer
Principal Medical Writer
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Job Description
The Medical Writing Manager is an individual expert contributor capable of independently executing complex writing assignments involving a thorough understanding of clinical trials 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.
This role has extensive clinical document expertise and will lead in the implementation of best practices and continuous improvement.
He/she has the ability to plan and prioritize without supervision.
Key Responsibilities:
Describe the key deliverables to be achieved by the post holder and the ongoing responsibilities of the role.
Proven track record in writing a range of clinical documents including regulatory documents following defined templates 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 fitforpurpose 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.
Highlevel 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.
Can mentor junior writers.
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.
Remote Work :
No
Employment Type
Full Time
