Associate Director, Medical Writing Asset Lead
il y a 1 semaine
Site Name:
Belgium-Wavre, Italy - Siena, Mississauga, UK - Hertfordshire - Stevenage
Posted Date:
Jun 9 2023
Job purpose:
Your responsibilities:
Leadership and Expertise:
- Lead one or more assets and serve as a medical writing point of contact for this/these assets. Support prioritising workload across an asset (s)to deliver MW portfolio.
- Lead matrix team to drive the delivery of high quality, fitforpurpose 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 behaviours 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 interdepartmental 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, decisionmaking, and pushing the performance edge within Medical Writing and in crossfunctional platforms.
- Highly pragmatic with strong negotiation skills (to propose creative solutions to new challenges)
Planning, Organisation 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 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.
Third-Party Resourcing Oversight:
- Lead external resourcing and CRO interactions for project resourcing agreements
- Implement third party resourcing agreements and oversee contract medical writers for document delivery
- Identify need for external resource support and negotiate timelines with external medical writing vendors/CROs.
_ Why you?_
Basic Qualifications:
- We are looking for professionals with these required skills to achieve our goals:_
- PhD or equivalent expertise in life sciences.
- 610 years' experience in clinical regulatory writing experience in the pharmaceutical industry, and demonstration of leadership.
- Demonstrate experience in multicultural settings (to reflect our external customers/clients [health authorities/patients] and diverse environments with respect to dynamics of human interaction (including working with remote teams).
- Capability to provide the Medical Writing strategy for the development of clinical programmes 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 criticalpath documents needed to deliver our pipeline) and put in place appropriate mitigation strategies.
- Accountable for Medical Writing support.
- Must have the
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