Principal Medical Writer

3 weeks ago

Mississauga, Canada GSK Full time

**Site Name**: Canada - Ontario - Mississauga, Brussels, La Plaine TSA, Warsaw

**Posted Date**: Jun 7 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._
- 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.

LI-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 positively impact the health of 2.5 billion people by the end of 2030.

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 ca

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