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Director, Medical Writing

Il y a 3 mois

Wavre, Wallonie, Belgique GSK Temps plein

Site Name:
Belgium-Wavre

Posted Date:
Jan

Director, Medical Writing:

Key Responsibilities include, but are not limited to:

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. Support prioritising workload across an asset(s) to deliver medical writing portfolio.
  • Drive medical writing strategy to ensure alignment with the portfolio strategy (e.g. prioritization, acceleration, meeting upper quartile performance).
  • 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.
  • Lead, 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 champion 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:

  • Contribute to asset development teams and project teams as needed to ensure Medical Writing strategy is communicated and discussed
  • Establish quality, efficiency, and effective teamwork across all document teams.
  • Work closely with submission leads 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:

  • 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 interdepartmental levels; ensure 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.
  • Motivate, influence, and advocate for medical writers, team members and senior stakeholders to effectively contribute to and review documents.
  • Promote 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 abovestudy 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 particularly for complex submissions.

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 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?_

Required
Qualifications**:

  • We are looking for professionals with these required skills to achieve our goals:_
  • PhD or relevant working experience within the life sciences space.
  • Extensive 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)

Preferred Qualifications:

  • If you have the following characteristics, it would be a plus_ _:_
  • Ability to lead and drive change within matrix team
  • Being open to innovative medical writing solutions and driving the implementation in the ass