Principal Medical Writer

Site Name: Bengaluru Luxor North Tower, Belgium-Wavre, Durham Blackwell Street, Italy - Rome, UK - London - Brentford

Posted Date: Nov 29 2023

Are you energized by a scientific writing role that allows you to shape operational strategy and accelerate compliance? If so, this Scientific & Medical Writing Manager role could be an exciting opportunity to explore.

As a Scientific & Medical Writing Manager, you will implement the operational strategy defined with the Head of Scientific Writing, tracking milestones and deliverables to manage the performance of the Scientific Writing team, ensuring consistency, regulatory compliance and the quality level of functional deliverables.

This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:

Develop the tools and environment to support risk management and management monitoring activities defined by the Head, Scientific Writing Business Excellence, including data collection, tracking, reporting, assessment, and presentation
Implement process management practices within Scientific Writing while verifying/validating project results and serve as the main point of contact for document retrieval
Lead Scientific Writing-led process improvement initiatives, change management, and the implementation of Standard Operating Procedures (SOPs) and business guidance/working standards
Support the Head, Scientific Writing Business Excellence, in establishing and maintaining collaborations with partnering organizations within GSK, and help embed and grow a process improvement culture within Scientific Writing, facilitating root cause/problem solving
Develop training material and toolkits for the Scientific Writing teams, including onboarding external collaboration, tracking training compliance for Scientific Writing including external collaborators
Support the Head, Scientific Writing Business Excellence in ensuring audits, independent monitoring and inspections related to Scientific Writing are adequately supported, tracked and outcomes requiring corrective action are managed to quality requirements
Track findings, observations and Corrective and Preventive Actions (CAPAs) related to Scientific Writing, ensuring all information are readily available and retrievable, assessing weak points/gaps across Scientific Writing and ultimately coordinating training initiatives accordingly
Develop team expertise in areas of interest or specific talent including:
risk facilitation, management monitoring and performance
process improvement, training, audit, assessment and inspection
change management, capacity building, toolkit generation, documentation/archiving

Why you?

Basic Qualifications:

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

Bachelor’s degree
7+ years of experience in the field of medical/scientific writing
Project management, planning, risk management, communication and leadership experience
Experience with International Council for Harmonization (ICH)/Good Clinical Practice (GCP) Guidelines

Preferred Qualifications:

If you have the following characteristics, it would be a plus:

Experience in Risk Management and Management Monitoring
Effective ability to prioritize tasks and deliver on deadlines
Proven track record of successfully managing simple to medium complex programs
Strong coalition-building and communication skills (both written and verbal)

Why GSK?

Our values and expectations are 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.