Manager, Medical Writing Scientist - Oncology
The Senior Medical Writing Scientist works 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.
• Directs the work of medical writing teams in medical writing projects in support of the Therapy Area clinical strategy
• Contributes to the planning, authoring, review, and approval of clinical documents for any medical writing project to achieve a successful outcome within the required timelines
• Reviews reporting and analysis plans and provides critical input on the content and display of tables
• Assesses trends and patterns in text and statistical data, and effectively organizes content and messages in clinical reports and summary documents
• Provides input or guidance to submission teams in development of submission plans. Advises on or recommends methods for achieving accelerated timelines as necessary
• Actively contributes to development of training materials for therapeutic area scientists and provides mentoring and/or training on clinical documentation and submission planning to individuals or teams
• Champions change and contributes to departmental or cross-functional process improvement initiatives and develops/revises standards for GSK submission documents
• Proposes resourcing solutions for major projects including number of FTEs required and best use of internal and external resource. Manage development of contracts/invoices and provide oversight for outsourced medical writing activities
• Effectively contributes to the evaluation of new business development plans or other process improvement activities
**STRONG REMOTE CANDIDATES WILL BE CONSIDERED
• Bachelors degree in life sciences & 7 plus years of writing experience & a minimum of 5 years of oncology experience; PhD strongly preferred
• Strong working knowledge of ICH guidelines for Common Technical Documents and Good Clinical Practice, FDA Code of Federal Regulations for New Drug Applications, European requirements for Marketing Authorization Applications, and other regulations governing clinical research and documentation
• Proven track record in writing clinical documents including, but not limited to: clinical study reports, NDA/MAA CTD submission documents, investigator brochures, briefing documents, and responses to regulatory authority questions
• Experience as a major contributor in planning and production of clinical dossiers documents for regulatory submissions worldwide
• Demonstrated effectiveness in management of projects of increasing scope and complexity
• Understanding of the interdependencies of various contributing functions and 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
• Demonstrated ability and willingness to adjust behaviors and priorities based on a changing environment
• Effectiveness in both oral and written communication
• Recent experience in the oncology therapeutic area
GSK has a 150-year legacy of helping to transform the health, lives and futures of millions of people around the world. We're a science-led healthcare company with more than 100,000 people working in 115 countries. Each year we produce around 4 billion packs of medicine, nearly 900 million doses of vaccine and more than 18 billion packs of consumer healthcare products. Our focus of helping people do more, feel better and live longer is at the center of all that we aim to do.
At GSK, our mission is to improve the quality of human life by enabling people to do more, feel better and live longer. Our three world-leading businesses research and deliver innovative medicines, vaccines and consumer healthcare products. We need a talented and motivated workforce to deliver against our strategy. To achieve this, we strive to attract the best people and to create an environment that empowers and inspires.
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