Associate Director Medical Writing Asset Lead
Are you energized by a scientific writing role that allows you to shape operational strategy and accelerate compliance? If so, this Associate Director Medical Writing and Asset Lead role could be an exciting opportunity to explore.
As an AD Medical Writing and Asset Lead, you will implement the operational strategy defined with the Head of Scientific Writing, tracking milestones and deliverables to manage the performance of the Scientific Writing team, ensuring consistency, regulatory compliance and the quality level of functional deliverables. Apply experience, scientific and operational expertise, and leadership in a matrix organization to provide Medical Writing strategy to one or more Therapy Area assets, the design and delivery of high-quality fit for purpose clinical documents including those for regulatory submissions, the plans for efficient and accelerated ways of working, and key organizational process improvements.
This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:
Apply experience, scientific and operational expertise, and leadership in a matrix organization to provide Medical Writing strategy to one or more Therapy Area assets, the design and delivery of high-quality fit for purpose clinical documents including those for regulatory submissions, the plans for efficient and accelerated ways of working, and key organizational process improvements.
Leadership and Expertise:
Lead one or more assets and serve as a medical writing point of contact for this/these assets. Support prioritizing workload across an asset (s)to deliver MW portfolio.
Lead matrix team to drive the delivery of high quality, fit-for-purpose clinical documents that accurately reflect associated data and are in line with GSK standards and global/regional/local regulatory requirements, while demonstrating high performance standards for own work and encouraging similar standards across the matrix teams.
Ensure Medical Writing strategy is aligned with the portfolio strategy (e.g. prioritization, acceleration, meeting upper quartile performance).
Drive, promote and implement key organizational process improvement initiatives. Proactively generate ideas for simplification and improvement taking advantage of opportunities that arise. Promote environment for others to generate ideas for improvement (e.g., continuously challenge the status quo) and champions novel business solutions in technology and ways of working.
Lead development of training materials for a range of clinical documents. Provide mentoring, coaching and/or training to individuals or teams to develop others and shared learnings.
Promote leadership behaviors that support GSK values.
Provide resourcing information to TA Head to contribute to budget forecast with early escalation of risks and opportunities to ensure optimal resource utilization.
Matrix Teamwork and Function:
Establish quality, efficiency and effective teamwork across all document teams.
Work closely with stakeholders to provide significant contribution to complex clinical submission documents, document strategy and on time, efficient document delivery.
Proven track record in writing clinical documents in scope.
Relationship, Influence and Communication:
Demonstrate a track record of leading and influencing teams in a matrix environment. Promote team effectiveness across assigned projects. Build and maintain networks at project, departmental and inter-departmental levels; ensures timely dissemination of information to appropriate levels to improve transparency and shared learnings.
Possess highly effective communication skills. Capable of clearly presenting ideas and data to a group, including key stakeholders at senior level or external formats
Influence and advocate for medical writers, team members and senior stakeholders to effectively contribute to and review documents.
Support a culture of open and honest conversations, smart risk taking, decision-making, and pushing the performance edge within Medical Writing and in cross-functional platforms.
Highly pragmatic with strong negotiation skills (to propose creative solutions to new challenges)
Planning, Organization and Team Coordination:
Able to develop and implement study and above study document and resourcing strategies to meet project team objectives and anticipated deliverables.
Able to develop a resourcing plan to enable efficient and accelerated delivery of documents and submissions.
Flexibility to adjust plans when project timings change.
Process Improvement and Compliance:
Support process improvement, training, quality and compliance through ideas, proactive action, and engagement in the matrix team.
Additional Job Responsibilities:
Capability to provide the Medical Writing strategy for the development of clinical programs and content of documents (through a variety of techniques)
Continually engage stakeholder departments, work with stakeholder departments to identify risks and opportunities and socialize new initiatives (e.g., new templates and processes)
Identify risks to strategic, ethical or compliance objectives (e.g., article 46 compliance or delivery of a critical-path documents needed to deliver our pipeline) and put in place appropriate mitigation strategies.
Measure and monitor efficiency, quality (incl. consistency) and scientific integrity of writing.
Ensure good writing practices and fluid communication within study teams.
Ensure appropriate leadership/ownership of writers on the clinical project teams to enable the optimal planning and delivery of documents (esp. for producing critical documents).
Drive thorough submission planning and delivery with application of agile, efficient and accelerated processes as needed.
We are looking for professionals with these required skills to achieve our goals:
PhD in a life science field of study.
6+ years’ experience in clinical regulatory writing experience in the pharmaceutical industry, in a lead role
6+ years Project management, planning, risk management, communication and leadership experience
6+ years working with International Council for Harmonization (ICH)/Good Clinical Practice (GCP) Guidelines
If you have the following characteristics, it would be a plus:
Experience in Risk Management and Management Monitoring
Effective ability to prioritize tasks and deliver on deadlines.
Proven track record of successfully managing simple to medium complex programs.
Strong coalition-building and communication skills (both written and verbal)