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2 months ago

Brentford, Greater London, United Kingdom GlaxoSmithKline Full time

Site Name: Belgium-Wavre, Bengaluru Luxor North Tower, Italy - Siena, UK - London - Brentford, USA - Pennsylvania - Upper Providence

Posted Date: Mar

Job purpose:

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.

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, 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 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 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, 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.
  • 6-10 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 critical-path documents needed to deliver our pipeline) and put in place appropriate mitigation strategies.
  • Accountable for Medical Writing support.
  • Must have the ability to work with cross-functional teams and communicate effectively.
  • Fluency in English, local language is a plus.
  • Sound scientific methodology and thinking.
  • Excellent presentation and communication skills.

#Li-GSK

Why GSK?

GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organisation where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years.

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves - feeling welcome, valued and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.

GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organisation where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years.

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We're committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce.

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