Site Name: UK - Hertfordshire - Stevenage, GSK HQ, Italy - Siena
Posted Date: Jan 8 2025
Director Medical Writing Process Management
At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. R&D is committed to discovering and delivering transformational vaccines and medicines to prevent and change the course of disease.
The Director Medical Writing Process Management will be accountable for overseeing and optimizing assigned end-to-end business processes within Medical Writing (MW) to drive efficiency, compliance, standardization, and continuous improvement across the organization. They will lead and work collaboratively with cross-functional teams to identify areas for process improvement & innovation, implement best practices, control process health & compliance, and ensure processes align with GSK’s strategic goals.
Key Responsibilities
1. As the Global Process Owner for assigned processes lead the design, maintenance, and continuous improvement of these end-to-end processes. Ensure these processes are aligned with MW’s strategies, consider innovative approaches being developed in the industry, drive efficiency, comply with regulatory requirements and are well defined. Provide necessary information and training to help users understand and implement these processes effectively.
2. Define and implement process oversight strategy with key performance indicators, in-process controls, management monitoring and end-user feedback. Establish benchmarks and conduct periodic review of performance metrics to ensure effectiveness, efficiency, and compliance.
3. Influence and engage with the organization by building a strong network with stakeholders, partners, and subject matter experts to understand their drivers and needs along with broader organizational goals.
4. Define and manage process change roadmaps, aligning priorities with system updates and innovations to address evolving business needs.
5. Lead strategy, planning, execution, and implementation of process change projects, ensuring improvements are achieved through a combination of process-people-system solutions.
Why you?
Basic Qualifications:
We are looking for professionals with these required skills to achieve our goals:
1. Extensive experience in Pharmaceutical or Biotech industry working in Clinical Operations, Medical Writing, Operational Excellence, or a related field.
2. Excellent understanding of clinical operations / medical writing processes, and ICH/GCP and global regulatory guidelines for drug development and approval processes.
3. Strong strategic and critical thinking, problem solving, influencing and decision-making capabilities.
4. Forward-thinking and visionary mindset to modernise approach to clinical processes and leverage technology.
5. Demonstrated cross-functional collaborator with experience in building networks of partners and stakeholders.
Preferred Qualifications:
BSc, advanced degree preferred
Closing Date for Applications: 31/01/2025 (EOD)
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.
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.
Our success absolutely depends on our people. 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 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.
As an Equal Opportunity Employer, we are open to all talent. In the US, we also adhere to Affirmative Action principles.
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