Medical Writing Standards & Compliance Associate Director

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Site Name: Belgium-Wavre

Posted Date: Dec 9 2022

Are you looking for a highly visible medical writing role that broadens your project management capabilities? If so this Medical Writing Standards and Compliance Associate Director role could be an ideal opportunity to consider.

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

• Lead management monitoring following implementation of science writing standards (eg, ensure implementation/replacement of any tools does not impact quality of communication of downstream information)
• Propose and champion design, development, and implementation of global system capabilities (eg, Veeva) to better support business needs, including engagement of all stakeholders
• Establishing and tracking KPIs for the function on a regular basis and highlight risks in achieving performance targets. This may include:
• Tracking submission timelines
• Concept protocol and protocol timelines
• Compliance such as Article 46 documents
• Track “best in class” practices in collaboration with external organizations (eg, EFPIA, EMWA, AMWA, publications in journals) to identify / predict emerging opportunities for efficiency, cost saving or faster document production
• Develop, implement, and monitor quality plan for the function (accountable for impact)
• Lead quality and training initiatives within the medical writing organization, working closely with internal and external partners
• Lead the implementation of new processes (eg: protocol, CSR, IB, submissions), evaluate the implementation effectiveness and drive compliance.
• In collaboration with the Head of Medical Writing Center of Excellence, measure and monitor quality and impact of the Medical Writing department’s output (Develop quality metrics)
• Lead and coordinate the review of training curriculum, in collaboration with Medical Writing Therapeutic Area heads and Medical Writing Asset Leads, Medical Writing Managers and learning solutions team (eg,MyLearnings)
• Accountable for performance tracking and risk management within medical writing and prepare the team for audit ready
  
  

Why you?

Basic Qualifications:

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

• 10-12 years’ experience in clinical research. Experience in project management, data analytical skills and audit preparation. Knowledge of medical writing processes is highly desirable.
• Demonstrate experience in multicultural settings and diverse environments particularly with respect to dynamics of working with remote teams.
• Project and people management skills.
• Strong negotiation skills (to propose creative solutions to new challenges and implementation of new digital tools).
• Process improvement approaches.
  
  

Preferred Qualifications:

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

• PhD, PharmD, MPH, MS or other post-graduate degree
• Possesses highly effective communication skills and is capable of presenting ideas and data clearly to a group, including key stakeholders at senior level.
• Demonstrated track record of quality decision making and creative problem resolution that impacts program/project direction.
  
  

Why GSK?

Uniting science, technology and talent to get ahead of disease 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 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.

If you have a disability and require assistance during the course of the selection process, you will have the opportunity to let us know what specific assistance you require in order to make suitable arrangements.

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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