Medical Writing & Clinical Submission Planning Director - Oncology
As a Medical Writing & Clinical Submission Planning Director you will 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.In the US, this position can be based at the GSK Collegeville, PA or Waltham, MA locations and can be remote based within the east coast time zone. Job Purpose and Key Responsibilities:
Apply experience, scientific and operational expertise, and leadership in a matrix organization to design and deliver high quality fit for purpose clinical regulatory documents and key organizational process improvements including regulatory submissions.
- Leadership and Expertise:
- Team leader and expert medical writing consultant.
- Lead one or more assets and serve as a medical writing point of contact for this/these assets.
- Lead matrix team in 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.
- Lead, drive, promote and implement key organizational process improvement initiatives. Proactively generate ideas for improvement taking advantage of opportunities that arise. Promote environment for others to generate ideas for improvement and champions improvements in technology and ways of working.
- Lead development of training materials for clinical documentation and submission planning. Provide mentoring, coaching and/or training to individuals or teams.
- Matrix Teamwork and Function:
- Establish quality, efficiency and effective teamwork across all document teams.
- Prioritize and successfully meet deadlines across multiple project teams with attention to detail. Provide significant contribution to complex clinical submission documents, document strategy and document delivery.
- Relationship, Influence and Communication:
- Build interactive relationships with team leaders and senior stakeholders.
- Demonstrate an outstanding 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.
- Possess highly effective communication skills. Capable of clearly presenting ideas and data to a group, including key stakeholders at senior level or external formats.
- Motivate, influence, and advocate for medical writers, team members and senior stakeholders to effectively contribute to and review documents.
- Planning and Team Coordination:
- Able to develop document and resourcing strategies to meet project team objectives.
- Determine resourcing strategy to meet anticipated deliverables.
- Process Improvement and Compliance:
- Lead process improvement, training, quality and compliance through ideas, proactive action, and engagement in the matrix team.
- Third-Party Resourcing Oversight:
- Lead external resourcing and CRO interactions.
- Initiate and implement third party resourcing agreements and oversee contract medical writers.
- Identify need for external resource support, negotiate timelines and cost with external medical writing vendors/CROs.
- Managing Direct Reports and Developing Organizational Talent
- Lead and manage a team of internal, contingent and/or contract medical writers to deliver the work specified above.
- Create opportunities to apply new skills and minimize barriers to development.
- Basic: Bachelor's degree in life sciences
If you have the following characteristics, it would be a plus:
- Master's degree in life sciences.
- Relevant professional experience.
- 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 skills.
- Demonstrated ability and willingness to adjust behaviors and priorities based on a changing environment (e.g., ability to support documents in different therapeutic areas).
- Possess highly effective communication skills and is capable of presenting ideas and data clearly to a group, including key stakeholders at a senior level.
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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