Director Medical Writing Process Management Siena

Director Medical Writing Process Management
Siena
Toscana, Siena

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.

Science and technology are coming together in a way they never have before, and we have strong tech-enabled capabilities that allow us to build a deeper understanding of the patient, human biology and disease mechanisms, and transform medical discovery.

We are revolutionising the way we do R&D. We're uniting science, technology and talent to get ahead of disease together.

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 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.

Ensure that written standards are developed and maintained as needed to support the process and that written standards can be clearly understood by end-users.

Provide necessary information and training to help users understand and implement these processes effectively.

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.

Report process health and compliance to the relevant stakeholders proactively and take appropriate measures where deficiencies are identified.

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.

Use these insights to craft alignment, drive meaningful change and improve end-user experience.

Define and manage process change roadmaps, aligning priorities with system updates and innovations to address evolving business needs, manage risks or interdependencies, and implement improvements at scale.

Lead strategy, planning, execution, and implementation of process change projects, ensuring improvements are achieved through a combination of process-people-system solutions.

Partner with subject matter experts and support roles to deliver a comprehensive solution package that includes the end-to-end process itself, written standards, training, communication, change management, implementation, and monitoring plans.

Why you?

Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: Extensive experience in Pharmaceutical or Biotech industry working in Clinical Operations, Medical Writing, Operational Excellence, or a related field.

Excellent understanding of clinical operations / medical writing processes, and ICH/GCP and global regulatory guidelines for drug development and approval processes.

Strong strategic and critical thinking, problem solving, influencing and decision-making capabilities.

Forward-thinking and visionary mindset to modernise approach to clinical processes and leverage technology.

Demonstrated cross-functional collaborator with experience in building networks of partners and stakeholders, and broadly engaging with expert communities.

Preferred Qualifications: BSc, advanced degree preferred Closing Date for Applications: 31/01/2025 (EOD) As an Equal Opportunity Employer, we are open to all talent.

In the US, we also adhere to Affirmative Action principles.

This ensures that all qualified applicants will receive equal consideration for employment without regard to neurodiversity, race/ethnicity, colour, national origin, religion, gender, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.

We believe in an agile working culture for all our roles.

If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.

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