Medical Writing Manager
Scientific and Medical Writing Manager I (Grade level 7):
• 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
• 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
• 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
Scientific and Medical Writing Manager II (Grade level 6): (In addition to items listed above)
• Direct the work of medical writing teams in medical writing projects in support of the clinical project strategy. May manage development of contracts/invoices for outsources medical writing activities
• Contribute to the planning, authoring, review, and approval of clinical documents for medical writing project to achieve a successful outcome within the required timelines
• Possess highly effective communication skills and is capable of presenting ideas and data clearly to a group, including key stakeholders at a senior level
• Provide major input to submission teams in development of submission plans, timelines, document content and dependencies. Advises on or recommends methods for achieving accelerated timelines as necessary
• Actively contribute to development of training materials for clinical document preparation; provides mentoring and/or training on clinical documentation and submission planning to individuals or teams
• Champion change and contributes to departmental or cross-functional process improvement initiatives and develops/revises standards for GSK submission documents
• Manage development of contracts/invoices and provide oversight for outsourced medical writing activities
• Effectively contribute to process improvement activities
• Bachelor degree in life sciences
• Scientific and Medical Writing Manager I: Up to 5 years of industry experience
• Scientific and Medical Writing Manager II: ≥ 6 years of industry experience
• Post-graduate degree in life sciences
• Expertise in one of the follow areas:
- Infectious disease
- Renal Disease
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.
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