Medical Writing Asset Lead

GSK
Middlesex, NJ Full Time
POSTED ON 12/3/2023 CLOSED ON 12/31/2023

What are the responsibilities and job description for the Medical Writing Asset Lead position at GSK?

Are you interested in a highly visible, impactful position that allows you to contribute to the delivery of GSK’s R&D pipeline (including products in the respiratory, immunology, specialty and oncology therapy areas)? Do you have the experience and drive to lead cross-functional teams, external vendors, and senior leaders, in the delivery of global drug licensing applications? If so, this role is an exciting move to explore.

At GSK, Medical Writing Asset Leads (MWALs) use their leadership, experience, scientific and operational expertise in medical writing while working within a matrix organization to plan and deliver the clinical components of global regulatory submissions. Furthermore, MWALs actively contribute to identifying efficiencies and acceleration strategies leading to key organisational process improvements and excellence in medical writing.

We create a place where people can grow, be their best, be safe, and feel welcome, valued and included. We offer a competitive salary, an annual bonus based on company performance, healthcare and wellbeing programmes, pension plan membership, and shares and savings programme.

We embrace modern work practises; our Performance with Choice programme offers a hybrid working model, empowering you to find the optimal balance between remote and in-office work.

Discover more about our company wide benefits and life at GSK on our webpage Life at GSK | GSK

In this role you will

  • Be a matrix team leader and expert medical writing consultant leading one or more assets and related strategies as a medical writing point of contact.
  • 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.
  • Lead, drive, promote and implement key organizational process improvement initiatives, including training materials for a range of clinical documents. Provide mentoring, coaching and/or training to individuals or teams to develop others and shared learnings.
  • Provide resourcing information to TA Head to contribute to budget forecast with early escalation of risks and opportunities to ensure optimal resource utilization.
  • Build interactive relationships with team leaders and senior stakeholders.
  • Lead external resourcing and CRO interactions for project resourcing agreements, oversight of contract medical writers, and the negotiation of delivery/project timelines.

Why you?

Basic Qualifications & Skills:

We are looking for professionals with these required skills to achieve our goals:

  • PhD degree in Life Sciences or equivalent experience.
  • Extensive experience in clinical regulatory writing in the pharmaceutical industry, and demonstration of leadership (people or matrix for project and process improvements).
  • Demonstrated experience in the authoring of the clinical components of global regulatory submissions.
  • Ability to interact with people at various levels of the organisation to present ideas, drive strategy, solve problems etc.
  • Project and people management skills in the matrix.
  • Strategic thinking with strong planning and organizational skills.
  • Demonstrated experience in working with different time-zones and cultures.

Preferred Qualifications & Skills:

Please note the following skills are not necessary, just preferred, if you do not have them, please still apply:

  • Demonstrated leadership as a medical writing submission lead in global regulatory submissions.
  • Experience with medical writing automation strategies.
  • A proven history of peer to peer coaching across R&D functions.
  • Demonstrated contribution to continuous improvement strategies in medical writing.

Closing Date for Applications – 31st December 2023 (COB)

Please take a copy of the Job Description, as this will not be available post closure of the advert. 
When applying for this role, please use the ‘cover letter’ of the online application or your CV to describe how you meet the competencies for this role, as outlined in the job requirements above. The information that you have provided in your cover letter and CV will be used to assess your application.

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