Responsibility for coordinating a team of writers to deliver study documents across all studies within a project according to our quality standards and business timelines.
- Direct the work of medical writing teams in medical writing projects in support of the clinical project strategy.
- 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 project teams and submission teams in development of cross project study documents, patient-facing documents, 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 project/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.
- Manage a team of writers to work on a variety of documents across studies and ensure the right level of resourcing with the right talent
- Define Scientific Writing project strategy,
- Ensure realistic planning (including stakeholder alignment) for high quality clinical/regulatory documentation for vaccine programs
- Provide leadership to set direction and drive Scientific Writing priorities to meet strategic, process and operational business needs within a clinical development project.
- Implement solutions for new regulatory and compliance requirements
Why you? Basic Qualifications:
- Build capability to meet the changing business and compliance environment by identifying opportunities to increase support through strengthening transversal collaboration across and project and facilitate knowledge transfer and sharing lessons learned, identification and escalation of risks … etc.
- Management oversight of writing resources, escalation of risks and opportunities to ensure optimal resource utilization.
- 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, patient-facing documents (plain language summaries/ICFs) and responses to regulatory authority questions.
- Experienced as a significant contributor in planning and production of clinical dossier and clinical study/project documents for regulatory and clinical trial submission/execution worldwide.
- Demonstrated effectiveness in management of projects of increasing scope and complexity.
- Understanding of the interdependencies of various contributing functions (e.g., adaptive designs, dose escalation, health outcomes and epidemiology).
- Ability to quickly assess complex situations, apply scientific, operational, and submission and clinical project-planning development knowledge and implement effective 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 study and cross-study clinical documents need to execute clinical trials and regulatory submissions.
- 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.
We are looking for professionals with these required skills to achieve our goals:
- Master Degree
- Experience with essential regulatory guidelines, detailed knowledge of GSK SOPs, ICH and FDA regulations as they impact all aspects of drug development.
- Scientific/pharmaceutical/vaccines industry background in research and development
- Detailed experience with drug/vaccines development and clinical processes.
- Manage a group of writers within a matrix environment to deliver of project objectives.
If you have the following characteristics, it would be a plus:
- Masters or Doctorate
- T horough knowledge and understanding of the Clinical Development processes
- Experience leading global teams
Our values and expectationsare at the heart of everything we do and form an important part of our culture.
These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:
- Agile and distributed decision-making - using evidence and applying judgement to balance pace, rigour and risk
- Managing individual and team performance.
- Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
- Implementing change initiatives and leading change.
- Sustaining energy and well-being, building resilience in teams.
- Continuously looking for opportunities to learn, build skills and share learning both internally and externally.
- Developing people and building a talent pipeline.
- Translating strategy into action - a compelling narrative, motivating others, setting objectives and delegation.
- Building strong relationships and collaboration, managing trusted stakeholder relationships internally and externally.
- Budgeting and forecasting, commercial and financial acumen.
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