Site Name: Mississauga Milverton Drive, UK – London – New Oxford Street Posted Date: Feb 5 2025 Are you energized by a medical writing role that allows you to shape clinical document strategy and accelerate product approvals? Do you have experience in oncology? If so, this Director Medical Writing Asset Lead role could be an exciting opportunity to consider. As Medical Writing Asset Lead Director, you will apply experience, scientific and operational expertise, and leadership in a matrix organization to provide the medical writing strategy for one or more oncology assets. You will design and deliver high-quality fit for purpose clinical documents for global regulatory submissions, plan for efficient and accelerated ways of working, and contribute to key organizational process improvements. This is a highly visible medical writing role, that will provide YOU the opportunity to lead key activities to progress YOUR career. Responsibilities of this role include: Providing key contributions to clinical document strategy for one or more oncology assets throughout the life cycle of drug development. Documents in scope include but are not limited to clinical study protocols, clinical sections of the IMPD/IND, investigator brochures, clinical study reports, briefing documents for regulatory authorities, Common Technical Document Summaries and Clinical Overview, and responses to regulatory authority questions. Leading matrix teams in planning and production of multiple clinical documents, working with CROs and/or independent contractors as needed. Planning and successfully delivering large submissions independently, effectively recommending innovative methods and solutions for achieving accelerated timelines. Assessing and adapting to interdependences of various contributing functions and managing problems affecting timelines as necessary. Ensuring a global approach for submissions as appropriate, collaborating with Global Regulatory Affairs to ensure business needs and regulatory requirements are met. Providing guidance and facilitation to submission teams in development of detailed submission plans. Acting as lead author on submissions. Effectively organizing content and arguments in complex clinical submission documents, including briefing documents and responses to regulatory questions. Proposing resourcing solutions for major projects including the number of FTEs required and best use of internal and external resources. Actively contributing to development of training materials for therapeutic area and providing mentoring and/or training on regulatory requirements, medical writing processes, and submission planning to individuals or teams. Driving, promoting and implementing key organizational process improvement initiatives. Proactively generating ideas for simplification and improvement taking advantage of opportunities that arise and challenging the status quo. Prioritizing and meeting multiple deadlines successfully with attention to detail, demonstrating high performance standards for own work and encouraging similar standards across the matrix. Promoting leadership behaviors that support GSK values. Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: PhD, PharmD, MPH, MSc, or other post-graduate degree Experience in oncology 10+ years’ experience in clinical regulatory writing in the pharmaceutical industry, with a proven track record of writing the clinical documents in scope. 10+ years’ experience in project management, planning, communication, and demonstrated matrix leadership to deliver results Excellent understanding of clinical operations / medical writing processes, and ICH/GCP and global regulatory guidelines for drug development and approval. Strong strategic and critical thinking, problem solving, influencing and decision-making capabilities. Preferred Qualifications: If you have the following characteristics, it would be a plus: Experience in delivering accelerated submissions for EU, US, China, Japan and Rest of World. Demonstrated cross-functional collaborator with effective communication skills and experience in building networks and influencing partners and stakeholders at all levels of the organization.- Why GSK? Our values and expectations are at the heart of everything we do and form an important part of our culture. These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities: Agile and distributed decision-making – using evidence and applying judgement to balance pace, rigor, and risk. 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 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. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology). 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. GSK is an equal opportunity employer committed to diversity and inclusion. We welcome applications from all qualified individuals to apply to our career opportunities. GSK is committed to accommodating persons with disabilities. If you need accommodation at any stage of the application process or want more information on our accommodation policies, please contact us at canada-recruitment@gsk.com. Please do not send resumes to this e-mail and instead apply through the online application process of this posting. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. 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