Director Medical Writing Asset Lead

GSK•Mississauga, ON

17h•€119,250 - €198,750•Hybrid

About The Position

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 and submissions strategy for one or more assets (main asset Hepatology.) 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. We encourage you to bring your disruptive thinking, collaborative spirit, and diverse perspective to our organization.

Requirements

PhD, PharmD, MPH, MSc, or other post-graduate degree
Substantial experience in clinical regulatory writing and regulatory submissions in the pharmaceutical industry, with a proven track record of writing the clinical documents in scope.
Strong experience in project management, planning, communication, and demonstrated matrix leadership to deliver results

Nice To Haves

Experience in delivering accelerated submissions for EU, US, China, Japan and Rest of World.
Experience in Hepatology therapy area.
Demonstrated cross-functional collaborator with effective communication skills and experience in building networks and influencing partners and stakeholders at all levels of the organization.
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.

Responsibilities

Providing key contributions to clinical document strategy for one or more 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. Incorporating, promoting and encouraging the adoption of technology for clinical documents within medical writing and the stakeholder landscape.
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.