Director Medical Writing Process Management

The Director Medical Writing Process Management will be accountable for overseeing and optimizing assigned end-to-end business processes within Medical Writing 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.
• Act as a change agent, effectively communicating and managing change initiatives to minimize disruption and maximize buy-in from stakeholders.
• Provide expertise and represent the process in different cross-business process work streams or be the work stream lead when relevant.
• Maintain current knowledge of global regulations and guidance, global regulatory expectations, regulation intelligence and industry standards pertaining to the assigned processes.
• Proactively assess impact of any new regulations on assigned process and ensure ongoing compliance.
• Proactively educate themselves in evolutions and innovations across the industry and evaluate how they could positively benefit the effectiveness, efficiency or compliance of the process.
• Develop and align proposals with the appropriate stakeholders to drive process innovation that is aligned with MW’s strategic priorities and stakeholder needs.
• Maintain personal readiness to respond to internal audits and regulatory inspections, be the point of contact and interact with inspectors, and provide expert advice to respond to audit observations.
• Represent GSK in external forums to influence the external ecosystem in shaping industry-leading practices and development of innovative methodologies.
• May act as mentor to more junior staff.

Basic Qualifications

• Bachelor’s degree in Scientific discipline.
• 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 matrix team leadership to deliver results.
• Demonstrated cross-functional collaborator with experience in building networks of partners and stakeholders and broadly engaging with expert communities.
• Effective communication skills with ability to communicate and influence at all levels of the organization.

Preferred Qualification

• Advanced degree in Scientific discipline.

GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law. If you require adjustments to our process to assist you in demonstrating your strengths and capabilities, contact us at UKRecruitment.Adjustments@gsk.com.